Interventions for treating proximal humeral fractures in adults
- PMID: 35727196
- PMCID: PMC9211385
- DOI: 10.1002/14651858.CD000434.pub5
Interventions for treating proximal humeral fractures in adults
Abstract
Background: Fractures of the proximal humerus, often termed shoulder fractures, are common injuries, especially in older people. The management of these fractures varies widely, including in the use of surgery. This is an update of a Cochrane Review first published in 2001 and last updated in 2015.
Objectives: To assess the effects (benefits and harms) of treatment and rehabilitation interventions for proximal humeral fractures in adults.
Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, trial registries, and bibliographies of trial reports and systematic reviews to September 2020. We updated this search in November 2021, but have not yet incorporated these results.
Selection criteria: We included randomised and quasi-randomised controlled trials that compared non-pharmacological interventions for treating acute proximal humeral fractures in adults. DATA COLLECTION AND ANALYSIS: Pairs of review authors independently selected studies, assessed risk of bias and extracted data. We pooled data where appropriate and used GRADE for assessing the certainty of evidence for each outcome. We prepared a brief economic commentary for one comparison.
Main results: We included 47 trials (3179 participants, mostly women and mainly aged 60 years or over) that tested one of 26 comparisons. Six comparisons were tested by 2 to 10 trials, the others by small single-centre trials only. Twelve studies evaluated non-surgical treatments, 10 compared surgical with non-surgical treatments, 23 compared two methods of surgery, and two tested timing of mobilisation after surgery. Most trials were at high risk of bias, due mainly to lack of blinding. We summarise the findings for four key comparisons below. Early (usually one week post injury) versus delayed (after three or more weeks) mobilisation for non-surgically-treated fractures Five trials (350 participants) made this comparison; however, the available data are very limited. Due to very low-certainty evidence from single trials, we are uncertain of the findings of better shoulder function at one year in the early mobilisation group, or the findings of little or no between-group difference in function at 3 or 24 months. Likewise, there is very low-certainty evidence of no important between-group difference in quality of life at one year. There was one reported death and five serious shoulder complications (1.9% of 259 participants), spread between the two groups, that would have required substantive treatment. Surgical versus non-surgical treatment Ten trials (717 participants) evaluated surgical intervention for displaced fractures (66% were three- or four-part fractures). There is high-certainty evidence of no clinically important difference between surgical and non-surgical treatment in patient-reported shoulder function at one year (standardised mean difference (SMD) 0.10, 95% confidence interval (CI) -0.07 to 0.27; 7 studies, 552 participants) and two years (SMD 0.06, 95% CI -0.13 to 0.25; 5 studies, 423 participants). There is moderate-certainty evidence of no clinically important between-group difference in patient-reported shoulder function at six months (SMD 0.17, 95% CI -0.04 to 0.38; 3 studies, 347 participants). There is high-certainty evidence of no clinically important between-group difference in quality of life at one year (EQ-5D (0: dead to 1: best quality): mean difference (MD) 0.01, 95% CI -0.02 to 0.04; 6 studies, 502 participants). There is low-certainty evidence of little between-group difference in mortality: one of the 31 deaths was explicitly linked with surgery (risk ratio (RR) 1.35, 95% CI 0.70 to 2.62; 8 studies, 646 participants). There is low-certainty evidence of a higher risk of additional surgery in the surgery group (RR 2.06, 95% CI 1.21 to 3.51; 9 studies, 667 participants). Based on an illustrative risk of 35 subsequent operations per 1000 non-surgically-treated patients, this indicates an extra 38 subsequent operations per 1000 surgically-treated patients (95% CI 8 to 94 more). Although there was low-certainty evidence of a higher overall risk of adverse events after surgery, the 95% CI also includes a slightly increased risk of adverse events after non-surgical treatment (RR 1.46, 95% CI 0.92 to 2.31; 3 studies, 391 participants). Open reduction and internal fixation with a locking plate versus a locking intramedullary nail Four trials (270 participants) evaluated surgical intervention for displaced fractures (63% were two-part fractures). There is low-certainty evidence of no clinically important between-group difference in shoulder function at one year (SMD 0.15, 95% CI -0.12 to 0.41; 4 studies, 227 participants), six months (Disability of the Arm, Shoulder, and Hand questionnaire (0 to 100: worst disability): MD -0.39, 95% CI -4.14 to 3.36; 3 studies, 174 participants), or two years (American Shoulder and Elbow Surgeons score (ASES) (0 to 100: best outcome): MD 3.06, 95% CI -0.05 to 6.17; 2 studies, 101 participants). There is very low-certainty evidence of no between-group difference in quality of life (1 study), and of little difference in adverse events (4 studies, 250 participants) and additional surgery (3 studies, 193 participants). Reverse total shoulder arthroplasty (RTSA) versus hemiarthroplasty There is very low-certainty evidence from two trials (161 participants with either three- or four-part fractures) of no or minimal between-group differences in self-reported shoulder function at one year (1 study) or at two to three years' follow-up (2 studies); or in quality of life at one year or at two or more years' follow-up (1 study). Function at six months was not reported. Of 10 deaths reported by one trial (99 participants), one appeared to be surgery-related. There is very low-certainty evidence of a lower risk of complications after RTSA (2 studies). Ten people (6.2% of 161 participants) had a reoperation; all eight cases in the hemiarthroplasty group received a RTSA (very low-certainty evidence).
Authors' conclusions: There is high- or moderate-certainty evidence that, compared with non-surgical treatment, surgery does not result in a better outcome at one and two years after injury for people with displaced proximal humeral fractures. It may increase the need for subsequent surgery. The evidence is absent or insufficient for people aged under 60 years, high-energy trauma, two-part tuberosity fractures or less common fractures, such as fracture dislocations and articular surface fractures. There is insufficient evidence from randomised trials to inform the choices between different non-surgical, surgical or rehabilitation interventions for these fractures.
Trial registration: ClinicalTrials.gov NCT01737060 NCT01984112 NCT02609906 NCT01847508 NCT00612391 NCT03383991 NCT01246167 NCT00438633 NCT02425267 NCT02122315 NCT00408291 NCT00384852 NCT00818987 NCT01532076 NCT02052206 NCT03017105 NCT02073695 NCT00835562 NCT01113411 NCT02075476 NCT01557413 NCT03100201 NCT03217344 NCT02362100 NCT00999193 NCT01524965 NCT02467803 NCT02913378 NCT02944058 NCT03498859 NCT03599336 NCT03610113 NCT03694457 NCT03786679 NCT04106674 NCT04553497 NCT02784522.
Copyright © 2022 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Conflict of interest statement
Patricia Aluko has no interests to declare. Stig Brorson was the lead investigator on Brorson 2009. No other interests to declare. Joanne Elliott has no interests to declare. Helen Handoll was a member of the trial management group of ProFHER 2015; an independent review of this trial was performed by Stig Brorson. No other interests to declare. Theis Thillemann has no interests to declare.
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Update of
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Interventions for treating proximal humeral fractures in adults.Cochrane Database Syst Rev. 2015 Nov 11;(11):CD000434. doi: 10.1002/14651858.CD000434.pub4. Cochrane Database Syst Rev. 2015. Update in: Cochrane Database Syst Rev. 2022 Jun 21;6:CD000434. doi: 10.1002/14651858.CD000434.pub5. PMID: 26560014 Updated.
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- NCT00438633. Comparison of early and late therapy for adults with non-operatively treated proximal humerus fractures (version 4). clinicaltrials.gov/show/NCT00438633 (first posted 22 February 2007).
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- NCT00438633. Comparison of early and late therapy for adults with non-operatively treated proximal humerus fractures (version 8; record updated 6 April 2015). clinicaltrials.gov/show/NCT00438633 (first posted 22 February 2007).
Rommens 1993 {published data only}
-
- Deldycke J, Rommens PM, Heyvaert G, Broos PL. Conservative treatment of sub-capital humerus fractures. A comparative study between the classical Desault-bandage and the new Gilchrist-bandage [Die konservative Behandlung von subkapitalen Humerusfrakturen. Eine vergleichende Studie zwischen dem klassischen Desault-Verband und der neuen Gilchrist-Bandage]. Hefte zur der Unfallchirurg 1993;232:145-6. - PubMed
-
- Rommens PM, Heyvaert G. Conservative treatment of subcapital humerus fractures. A comparative study of the classical Desault bandage and the new Gilchrist bandage [Die konservative behandlung subkapitaler humerusfrakturen. Eine vergleichende studie zwischen dem klassischen Desault-verband und der neuen Gilchrist-bandage]. Unfallchirurgie 1993;19(2):114-8. - PubMed
Sebastiá‐Forcada 2014 {published data only}
-
- Sebastiá-Forcada E, Cebrián-Gómez R, Lizaur-Utrilla A, Gil-Guillén V. Reverse shoulder arthroplasty versus hemiarthroplasty for acute proximal humeral fractures. A blinded, randomized, controlled, prospective study. Journal of Shoulder and Elbow Surgery 2014;23(10):1419-26. - PubMed
Smejkal 2011 {published data only}
-
- Smejkal K, Didek T, Zvak I, Trlica J, Folvarsky J. Operation treatment of 2-3 fragments proximal humeral fractures using Zifko versus Philos [abstract]. European Journal of Trauma & Emergency Surgery 2008;34(Suppl 1):44-5.
-
- Smejkal K, Lochman P, Dedek T, Trlica J, Koci J, Zvak I. Surgical treatment for proximal humerus fracture [Operacni lecba zlomenin proximalniho humeru]. Acta Chirurgiae Orthopaedicae et Traumatologiae Cechoslovaca 2011;78(4):321-7. - PubMed
Sohn 2017 {published data only}
-
- Sohn HS, Jeon YS, Lee J, Shin SJ. Clinical comparison between open plating and minimally invasive plate osteosynthesis for displaced proximal humeral fractures: a prospective randomized controlled trial. Injury 2017;48(6):1175-82. - PubMed
Soliman 2013 {published data only}
-
- PACTR201205000381245. Proximal humeral fractures treated with hemiarthroplasty. Does tendodesis of the long head of the biceps improve results? apps.who.int/trialsearch/Trial2.aspx?TrialID=PACTR201205000381245 (registered 10 May 2012).
-
- Soliman O. Comment on when 8 patients were excluded [personal communication]. Email to: H Handoll 6 May 2015.
-
- Soliman O. Information on implant manufacturer, and complications and reoperations [personal communication]. Email to: H Handoll 3 May 2015.
-
- Soliman OA, Koptan WMT. Proximal humeral fractures treated with hemiarthroplasty: does tenodesis of the long head of the biceps improve results? Injury 2013;44(4):461-4. - PubMed
Stableforth 1984 {published data only}
-
- Stableforth PG. Four-part fractures of the neck of the humerus. Journal of Bone and Joint Surgery. British Volume 1984;66(1):104-8. - PubMed
Torrens 2012 {published data only}
-
- Torrens C, Perez FS, Rigol P, Puig L. Management of conservatively treated proximal humeral fractures: prospective randomized study [abstract]. American Academy of Orthopaedic Surgeons. 2012 Mar 7-11; San Francisco (CA). www.aaos.org/education/anmeet/prevmeet.asp (accessed 26 February 2013) 2012.
-
- Torrens C. Additional trial data and information [personal communication]. Email to: H Handoll 10 June 2015.
-
- Torrens C. Clarification of study numbers [personal communication]. Email to: H Handoll 4 June 2015.
Tousignant 2020 {published data only}
-
- Cabana F, Page C, Svotelis A, Langlois-Michaud S, Tousignant M. Is an in-home telerehabilitation program for people with proximal humerus fracture as effective as a conventional face-to-face rehabilitation program? A study protocol for a noninferiority randomized clinical trial. BMC Sports Science, Medicine and Rehabilitation 2016;8(27):[8 p.]. [DOI: 10.1186/s13102-016-0051-z] - DOI - PMC - PubMed
-
- NCT02425267. Effectiveness of a home telerehabilitation program for people with proximal humerus fracture (version 5, 23 May 2019). clinicaltrials.gov/show/NCT02425267 (first received 20 April 2015).
-
- Page C. Publication of full report [personal communication]. Email to: H Handoll 3 February 2020.
-
- Tousignant M, Cabana F, Langlois-Michaud S, Brière S, Pagé C. In-home telerehabilitation for proximal humerus fractures compared to conventional rehabilitation: a randomized trial. Acta Scientific Medical Sciences 2020;4(2):1-6.
Voigt 2011 {published data only}
-
- Voigt C, Geisler A, Hepp P, Schulz AP, Lill H. Are polyaxially locked screws advantageous in the plate osteosynthesis of proximal humeral fractures in the elderly? A prospective randomized clinical observational study. Journal of Orthopaedic Trauma 2011;25(10):596-602. - PubMed
-
- Voigt C. Additional information and clarification of those not completing follow-up and gender data [personal communication]. Email to: H Handoll 30 May 2012.
Wirbel 1999 {published data only}
-
- Wirbel R, Knorr V, Saur B, Duhr B, Mutschler W. Minimally invasive fixation of displaced proximal humeral fractures. Orthopaedics and Traumatology 1999;7(1):44-53.
-
- Wirbel RJ, Knorr V, Mutschler W. Minimal invasive therapy in dislocated proximal humerus fractures. Influence of post-operative immobilisation on the function outcome [Minimal invasive Therapie bei dislozierten proximalen Humerusfrakturen. Einfluss der postoperativen Immobilisation auf das funktionelle Ergebnis]. Hefte zur der Unfallchirurg 1997;268:678-81.
Zhang 2011 {published data only}
-
- Zhang D. [personal communication]. Email to: H Handoll 14 May 2012.
Zhang 2019 {published data only}
-
- Zhang J, Zhou SJ, Cai F, Ma Y. Efficacy of proximal humeral internal locking system combined with allogeneic femoral head bone grafts for complex osteoporotic proximal humeral fractures. International Journal of Clinical and Experimental Medicine 2019;12(7):8847-54.
Zhu 2011 {published data only}
-
- Zhu Y, Lu Y, Shen J, Zhang J, Jiang C. Locking intramedullary nails and locking plates in the treatment of two-part proximal humeral surgical neck fractures: a prospective randomized trial with a minimum of three years of follow-up. Journal of Bone and Joint Surgery. American Volume 2011;93(2):159-68. - PubMed
Ziegler 2019 {published data only}
-
- DRKS00011376. PEEK (Polyetheretherketon) power plate for the treatment of proximal humerus fractures: a prospective study and comparison to fixation with a conventional locking plate (version 3 submitted 13 August 2018). www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DR... (first posted 25 November 2016).
Zyto 1997 {published data only}
-
- Karladani HA. Treatment of displaced proximal humeral fractures in elderly patients [Letter and reply]. Journal of Bone and Joint Surgery. British Volume 1999;81(1):181-2. - PubMed
-
- Tornkvist H, Ahrengart L, Sperber A. Tension band wiring vs. non-operative treatment of displaced proximal humerus fractures. A prospective randomized study [abstract]. Orthopaedic Transactions 1997;21(2):592.
-
- Tornkvist H, Ahrengart L, Sperber A. Tension band wiring vs. nonoperative treatment of proximal humerus fractures - a prospective randomized study [Abstract]. Acta Orthopaedica Scandinavica. Supplementum 1995;66(265):40-1.
-
- Zyto K, Ahrengart L, Sperber A, Tornkvist H. Treatment of displaced proximal humeral fractures in elderly patients. Journal of Bone and Joint Surgery. British Volume 1997;79(3):412-7. - PubMed
-
- Zyto K. Explanation of reasons for excluding participants [personal communication]. Letter to: H Handoll 21 March 1997.
References to studies excluded from this review
ACTRN12610000730000 {unpublished data only}
-
- ACTRN12610000730000. Minimally invasive versus standard open reduction of proximal humerus fractures. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=335913 (first posted 1 September 2010).
Arias‐Buria 2015 {published data only}
-
- Arias-Buria JL, Valero-Alcaide R, Cleland JA, Salom-Moreno J, Ortega-Santiago R, Atin-Arratibel MA, et al. Inclusion of trigger point dry needling in a multimodal physical therapy program for postoperative shoulder pain: a randomized clinical trial. Journal of Manipulative and Physiological Therapeutics 2015;38(3):179-87. [DOI: ] - PubMed
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- Arias-Buria Jl, Valero-Alcaide R, Cleland JA, Salom-Moreno J, Ortega-Santiago R, Atin-Arratibel MA. Inclusion of trigger point dry-needling in a multimodal physical therapy program for postoperative shoulder pain: a randomised controlled trial. New Zealand Journal of Physiotherapy 2016;44(2):113. - PubMed
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- NCT02122315. Dry needling in post-operative shoulder pain. www.clinicaltrials.gov/ct2/show/NCT02122315 (first posted 14 April 2014).
-
- Twaddle R. Inclusion of trigger point dry-needling in a multimodal physical therapy program for postoperative shoulder pain: a randomised controlled trial. New Zealand Journal of Physiotherapy 2016;44(2):113.
Avci 2013 {published data only}
Bai 2014 {published data only}
-
- Bai LC, Gu S, Xiong Y, Liu BL, Zhao F, Wang DX. Optimal position of locking compression plate for proximal humeral fractures: choice of lateral deltoid splitting approach? Chinese Journal of Tissue Engineering Research 2014;18(9):1453-8. [DOI: 10.3969/j.issn.2095-4344.2014.09.024] - DOI
Bai 2015 {published data only}
-
- Bai JZ, Hou B, Shi HF, Yang W, Xu G, Liang CG. Prognosis of locking plate versus ordinary steel plate fixation for proximal humeral fractures. Chinese Journal of Tissue Engineering Research 2015;19(26):4213-7. [DOI: 10.3969/j.issn.2095-4344.2015.26.022] - DOI
Baudi 2014 {published data only}
-
- Baudi P, Campochiaro G, Serafini F, Gazzotti G, Matino G, Rovesta C, et al. Hemiarthroplasty versus reverse shoulder arthroplasty: comparative study of functional and radiological outcomes in the treatment of acute proximal humerus fracture. Musculoskeletal Surgery 2014;98(Suppl 1):19-25. [DOI: 10.1007/s12306-014-0322-3] - DOI - PubMed
Bing 2002 {unpublished data only}
-
- Armstrong A. [personal communication]. Email to: H Handoll 17 July 2010.
-
- Bing AJ, Eastwood G, Sharma R, Cross R, Taylor GS, Harper WM. A randomised prospective trial comparing Polarus nail and Rush pins for fixation of proximal humeral fractures - Poster A5. In: British Orthopaedic Association Annual Congress; 2002 Sept 18-20; Cardiff (UK). London (UK): British Orthopaedic Association, 2002:2.
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- Sharma R. A prospective, randomised clinical trial to compare Rush pins fixation with Polaris nail fixation of displaced two part fractures of the proximal humerus. In: National Research Register, Issue 2, 2000. Oxford: Update Software.
Bolano 1995 {published data only}
-
- Bolano LE. Operative treatment of humeral shaft fractures: a prospective, randomized study of intramedullary nailing versus dynamic compression plating [abstract]. Orthopaedic Transactions 1995;19(1):33.
Brownson 2001 {unpublished data only}
-
- Brownson P. A prospective randomised trial comparing conservative treatment and the Halder Humeral Nail for displaced fractures of the surgical neck and shaft of the humerus. In: National Research Register, Issue 2, 2000. Oxford: Update Software.
Caforio 2017 {published data only}
Caliskan 2019 {published data only}
Carbone 2012 {published data only}
Chapman 1997 {published data only}
-
- Chapman J, Weber TG, Henley B, Benca PJ. Randomized prospective study of humerus fixation: nails vs. plates [abstract]. Orthopaedic Transactions 1997;21(2):594.
-
- Chapman J, Weber TG, Henley MB, Benca P. Randomized prospective study of humerus fixation: nails vs. plates [abstract]. Orthopaedic Transactions 1996;20(1):10.
Chen 2014 {published data only}
-
- Chen Q, Ji L, Pan Z, Zhou X, Zhu J, Cao Z, et al. Treating Neer two- and three-part proximal humeral fractures through anterolateral acromial approach and deltopectoral approach. Zhongguo Gu Shang [China Journal of Orthopaedics and Traumatology] 2014;27(12):991-4. - PubMed
Chen 2019 {published data only}
Chen H 2018 {published data only}
Chen JL 2018 {published data only}
-
- Chen JL, Chang FC, Lin SJ, Chuang PY, Peng KT, Huang KC, et al. The outcome of surgical management of proximal humeral fractures using locking plates: comparison between locking plates with different geometry. Journal of Shoulder and Elbow Surgery 2018;27(12):2159-66. [DOI: 10.1016/j.jse.2018.05.033] - DOI - PubMed
ChiCTR1900025412 {published data only}
-
- ChiCTR1900025412. Different interventions treating 3- or 4-part proximal humeral fracture in elderly patient: a prospective study. who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR1900025412 (first posted 26 August 2019).
ChiCTR‐TRC‐14004213 {published data only}
-
- ChiCTR-TRC-14004213. Immediate or delayed passive motion after operation of old fractures of greater tuberosity. who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR-TRC-14004213 (first posted 19 January 2014).
Chiu 1997 {published data only}
-
- Chiu FY, Chen CM, Lin CF, Lo WH, Huang YL, Chen TH. Closed humeral shaft fractures: a prospective evaluation of surgical treatment. Journal of Trauma 1997;43(6):947-51. - PubMed
Cigni 2012 {published data only}
-
- Cigni S, Battista E, Chessa A, Pietrogrande L. Stability plate surgery in proximal humerus fractures: deltoidpectoral approach versus direct lateral transdeltoid approach [abstract]. Journal of Orthopaedics and Traumatology 2012;13(Suppl 1):S20.
De Boer 2003 {unpublished data only}
-
- Booth C. Study status [personal communication]. Contact with H Handoll 20 March 2003.
-
- De Boer P. Plating of proximal humerus fracture: a blind comparative study. In: National Research Register, Issue 1, 2003. Oxford: Update Software.
-
- De Boer P. Study design [personal communication]. Contact with H Handoll 12 March 2003.
Dias 2001 {unpublished data only}
-
- Armstrong A. Study stopped [personal communication]. Email to: H Handoll 17 July 2010.
-
- Der Tavitian J. The management of comminuted proximal humeral fractured, a randomised prospective trial. In: National Research Register, Issue 3, 2006. Oxford; Update Software.
-
- Dias J. Study status [personal communication]. Contact with H Handoll 16 November 2001.
Edelson 2008 {published data only}
-
- Edelson G, Safuri H, Salami J, Vigder F, Militianu D. Natural history of complex fractures of the proximal humerus using a three-dimensional classification system. Journal of Shoulder & Elbow Surgery 2008;17(3):399-409. - PubMed
Elidrissi 2013 {published data only}
-
- Elidrissi M, Bensaad S, Shimi M, Elibrahimi A, Elmrini A. Surgical treatment of proximal humeral fractures anatomical plate versus palm tree pinning (26 cases) [Le traitement chirurgical des fractures de l'extrémité supérieure de l'humérus: plaque anatomique versus embrochage en palmier, à propos de 26 cas]. Chirurgie de la Main. 2013;32(1):25-9. - PubMed
Erdoğan 2014 {published data only}
-
- Erdoğan M, Desteli EE, İmren Y, Üztürk A, Kılıç M, Sezgin H. The effect of inferomedial screw on postoperative shoulder function and mechanical alignment in proximal humerus fractures. European Journal of Orthopaedic Surgery & Traumatology 2014;24(7):1055-9. - PubMed
EUCTR 2015‐001820‐51 {published data only}
-
- EUCTR2015-001820-51-DE. BMC2012, Cell based therapy by implanted bone marrow-derived mononuclear cells (BMC) for bone augmentation of plate-stabilized proximal humeral fractures - a randomized, open, multicentric study - phase IIa [BMC2012, Zellbasierte Therapie mit bone marrow-derived mononuclear cells (BMC) zur Knochenaugmentation bei der Osteosynthese proximaler Humerusfrakturen - eine randomisierte, offene, multizentrische Phase IIa Studie]. clinicaltrialsregister.eu/ctr-search/trial/2015-001820-51/DE (first posted 15 October 2015).
-
- NCT02803177. Cell therapy by autologous BMC for large bone defect repair (BMC2012) (Version 7). clinicaltrials.gov/ct2/show/NCT02803177 (first posted 16 June 2016).
Fan 2012 {published data only}
-
- Fan Y, Wang S, Luo Y. Effectiveness comparison of operative and non-operative treatment for complex proximal humeral fractures in elderly patients. Chung-Kuo Hsiu Fu Chung Chien Wai Ko Tsa Chih [Chinese Journal of Reparative & Reconstructive Surgery] 2012;26(9):1029-32. - PubMed
Flannery 2006 {unpublished data only}
-
- Flannery M. A prospective randomised trial for the treatment of four part fractures of proximal humerus: "conservative vs hemiarthroplasty". In: National Research Register, Issue 3, 2006. Oxford; Update Software.
-
- Flannery M. No recruitment at centre [personal communication]. Email to: H Handoll 16 November 2006.
-
- Turner R. Study stopped [personal communication]. Contact with H Handoll 19 November 2006.
Ge 2017 {published data only}
Ge 2019 {published data only}
-
- Ge HQ, Bai YY, Tang BB, Guan H. Floating needle therapy for postoperative functional rehabilitation in patients with surgical neck fracture of humerus: a randomized controlled trial. Zhongguo Zhen Jiu [Chinese Acupuncture And Moxibustion] 2019;39(5):473-6. [DOI: 10.13703/j.0255-2930.2019.05.004] - DOI - PubMed
Gradl 2009 {published data only}
Hems 2000 {unpublished data only}
-
- Hems T. A prospective randomised trial comparing conservative treatment and the Halder Humeral Nail for displaced fractures of the surgical neck and shaft of the humerus. In: National Research Register, Issue 3, 2000. Oxford: Update Software.
HOMERUS {unpublished data only}
-
- Diercks RL. Trial status [personal communication]. Email to: H Handoll 13 June 2020.
-
- NTR2354. Hemiarthroplasty versus osteosynthesis in humeral fractures (HOMERUS): a multicenter randomized trial (accessed 12 June 2020) (renumbered). www.trialregister.nl/trial/2354 (registered 10 August 2010).
-
- NTR2461. Hemiarthroplasty versus osteosynthesis in humeral fractures (HOMERUS): a multicenter randomized trial (accessed 10 April 2012). www.trialregister.nl/trialreg/admin/rctview.asp?TC=2461 (registered 10 August 2010).
-
- Verbeek PA, Van den Akker-Scheek I, Wendt KW, Diercks RL. Hemiarthroplasty versus angle-stable locking compression plate osteosynthesis in the treatment of three- and four-part fractures of the proximal humerus in the elderly: design of a randomized controlled trial. BMC Musculoskeletal Disorders 2012;13(16):[7 p.]. [DOI: 10.1186/1471-2474-13-16] - DOI - PMC - PubMed
IRCT2013052313435N1 {unpublished data only}
-
- IRCT2013052313435N1. Comparing review of the treatment results based on surgical or nonsurgical methods in the patients with fracture of proximal humerus referred to Al-Zahra and Kashani Hospitals (Isfahan) during 1388 -1392 (years). apps.who.int/trialsearch/Trial2.aspx?TrialID=IRCT2013052313435N1 (registered 8 August 2013).
ISRCTN32335957 {published data only}
-
- ISRCTN32335957. Prospective randomised study of reverse shoulder prosthesis and hemiarthroplasty for elderly patients with proximal humeral fractures. www.controlled-trials.com/ISRCTN32335957 (first registered 14 March 2007).
-
- Smith M. Study closed [personal communication]. Email to: H Handoll 27 April 2012.
Jin 2016 {published data only}
Kim 2016 {published data only}
-
- Kim J-W, Oh C-W, Oh J-K, Park K-H. Is minimally invasive plate osteosynthesis helpful in the fixation of 2-part proximal humerus fractures compared to open plating? (abstract). In: Orthopaedic Trauma Association Annual Meeting, 2016 October 5–8; National Harbor (MD). 2016.
Kim 2018 {published data only}
-
- Kim DS, Lee DH, Chun YM, Shin SJ. Which additional augmented fixation procedure decreases surgical failure after proximal humeral fracture with medial comminution: fibular allograft or inferomedial screws? Journal of Shoulder and Elbow Surgery 2018;27(10):1852-8. [DOI: ] - PubMed
Kulkarni 2000 {unpublished data only}
-
- Kulkarni R. Welsh proximal humeral fracture project. In: National Research Register, Issue 2, 2000. Oxford: Update Software.
Li 2015 {published data only}
-
- Li D, Zhang GW, Liu JB. Minimally invasive and open reduction plate fixation for proximal humerus fractures: range of motion of the shoulder joint. Chinese Journal of Tissue Engineering Research 2015;19(39):6355-9. [DOI: 10.3969/j.issn.2095-4344.2015.39.022] - DOI
Liao 2009 {published data only}
-
- Liao C, Wang P, Xie Y, Fan T, Li P, Liang W. Different surgical methods for treatment of senile osteoporotic comminuted proximal humerus fracture. Zhongguo Xiufu Chongjian Waike Zazhi [Chinese Journal of Reparative and Reconstructive Surgery] 2009;23(12):1443-6. - PubMed
Maniscalco 2014a {published data only}
-
- Maniscalco P, Caforio M. The importance of early rehabilitation in proximal humeral fracture: a randomized controlled clinical trial of efficacy and safety of endomedullary Diphos nail [abstract]. Journal of Orthopaedics and Traumatology 2014;15(Suppl 1):S32-3.
Martetschlager 2012 {published data only}
-
- Martetschlager F, Siebenlist S, Weier M, Sandmann G, Ahrens P, Braun K, et al. Plating of proximal humeral fractures. Orthopedics 2012;35(11):e1606-12. - PubMed
Martin 2000 {published data only}
-
- Heath C. The effect of interfential current on pain following proximal fracture of the humerus. A single blind, randomised, controlled clinical trial. In: National Research Register, Issue 4, 2001. Oxford: Update Software.
-
- Martin D, Palmer S, Heath C. Interferential current as an adjunct to exercise and mobilisation in the treatment of proximal humerus fracture pain: lack of evidence of an additional effect [Abstract]. Physiotherapy 2000;86(3):147.
-
- Palmer S. Compromised trial will not be reported [personal communication]. Email to: H Handoll 9 May 2003.
Mechlenburg 2009 {unpublished data only}
-
- Mechlenburg IB. Trial abandoned [personal communication]. Email to: H Handoll 25 May 2010.
-
- NCT00408291. Comparison of the Philos plate and cemented hemiprosthesis (Bigliani) in the treatment of three- and four-part fractures of the proximal humerus: a prospective, randomised migration and bone density study (Version 6). clinicaltrials.gov/show/NCT00408291 (first posted 6 December 2006).
-
- NCT00408291. Evaluation of the Winsta PH osteosynthesis device in the treatment of three- and four-part fractures of the proximal humerus: a prospective migration and bone density study (Version 8). clinicaltrials.gov/show/NCT00408291 (first posted 6 December 2006).
NCT00205959 {published data only}
-
- NCT00205959. LPHP-Philos-PHN conservative treatment (version 2; record updated 6 September 2006). clinicaltrials.gov/ct2/show/NCT00205959 (first posted 21 September 2005).
NCT00384852 {unpublished data only}
-
- Lo K. Study status [personal communication]. Email to: H Handoll 12 February 2015.
-
- NCT00384852. A study of rhBMP-2/CPM in closed fractures of the humerus (Version 15 posted 28 February 2013). clinicaltrials.gov/ct2/show/NCT00384852 (first posted 6 October 2006).
NCT00818987 {unpublished data only}
-
- NCT00818987. Operative versus non operative treatment of proximal humerus (shoulder joint) fractures (Version 1). clinicaltrials.gov/show/NCT00818987 (first posted 8 January 2009).
-
- NCT00818987. Operative versus non operative treatment of proximal humerus (shoulder joint) fractures (Version 4). clinicaltrials.gov/show/NCT00818987 (first posted 8 January 2009).
-
- Roffey D. Status of trial [personal communication]. Email to: H Handoll 22 July 2020.
NCT01086202 {published data only}
-
- NCT01086202. Clinical outcome comparison between medial and lateral offset reverse shoulder arthroplasty (version 2; updated 25 March 2010). clinicaltrials.gov/show/NCT01086202 (first posted 15 March 2010).
-
- NCT01086202. Clinical outcome comparison between medial and lateral offset reverse shoulder arthroplasty (version 6; updated 16 September 2016). clinicaltrials.gov/show/NCT01086202 (first posted 15 March 2010).
NCT01532076 {unpublished data only}
-
- NCT01532076. Effectiveness of adipose tissue derived mesenchymal stem cells as osteogenic component in composite grafts (ROBUST) (Version 3, updated 17 September 2014). www.clinicaltrials.gov/ct2/show/NCT01532076 (first posted 13 February 2012).
NCT01817933 {published data only}
-
- NCT01817933. Integrated rehabilitation program for fractures (Version 1). clinicaltrials.gov/ct2/show/NCT01817933 (first posted 26 March 2013).
NCT02052206 {unpublished data only}
-
- NCT02052206. Accuracy evaluation of shoulder replacement surgery (Version 1). www.clinicaltrials.gov/ct2/show/NCT02052206 (first received 31 January 2014).
-
- NCT02052206. Reconstruction of complex proximal humeral fractures (version 6, 24 November 2017). www.clinicaltrials.gov/ct2/show/NCT02052206 (first received 31 January 2014).
NCT02597972 {published data only}
-
- NCT02597972. Reverse total shoulder arthroplasty versus open reduction internal fixation of 3&4 part proximal humerus fractures (Version 7). clinicaltrials.gov/ct2/show/NCT02597972 (first posted 5 November 2015).
NCT03017105 {published data only}
-
- Bardsley J. Trial status: early termination due to "very low recruitment" [personal communication]. Email to: H Handoll 30 June 2020.
-
- NCT03017105. Cross-education for proximal humerus fracture rehabilitation (Version 1). clinicaltrials.gov/ct2/show/NCT03017105 (first posted 11 January 2017).
NCT03804853 {published data only}
-
- NCT03804853. Rehabilitation following reverse total shoulder arthroplasty (Version 3). clinicaltrials.gov/ct2/show/NCT03804853 (first posted 15 January 2019).
NCT04285606 {published data only}
-
- NCT04285606. Effect of postop rehab methods on outcomes following reverse shoulder arthroplasty (Version 3). clinicaltrials.gov/show/NCT04285606 (first posted 26 February 2020).
NTR2186 {unpublished data only}
-
- NTR2186. Delta Xtend reversed shoulder prosthesis. apps.who.int/trialsearch/Trial2.aspx?TrialID=NTR2186 (first posted 28 January 2010).
Parnes 2005 {published data only}
-
- Parnes N, Pritsch T, Mozes G. Is surgery the best choice in the treatment of complex fractures of proximal humerus? Preliminary study on 50 cases [Abstract]. Journal of Bone & Joint Surgery - British Volume 2005;87(Suppl 3):384.
Pullen 2007 {unpublished data only}
-
- Pullen H. Comparison of the T2 procimal humeral nail and PHILOS system in the treatment of 2+3 part proximal humeral fractures. In: National Research Register, Issue 3, 2006. Oxford; Update Software.
Rasool 2015 {published data only}
-
- Rasool K, Zubair M, Muhammad E, Akhtar S. Outcome of open reduction and internal fixation using plate versus closed reduction and percutaneous fixation using K-wires for treatment of two part proximal humerus fracture. Pakistan Journal of Medical and Health Sciences 2015;9(4):1257-9.
Rodriguez‐Merchan 1995 {published data only}
-
- Rodriguez-Merchan EC. Compression plating versus Hackethal nailing in closed humeral shaft fractures failing nonoperative reduction. Journal of Orthopaedic Trauma 1995;9(3):194-7. - PubMed
Rollo 2019 {published data only}
-
- Rollo G, Porcellini G, Rotini R, Bisaccia M, Pichierri P, Paladini P, et al. A new plate design to treat displaced 3-4 parts proximal humeral fractures in comparison to the most tested and used plate: clinical and radiographic study. Medicinski Glasnik 2019;16(2):284-91. [DOI: 10.17392/1033-19] - DOI - PubMed
ROTATE 2019 {unpublished data only}38563880
-
- Kassam AM, Ainsworth B, Hawken R, Ramesh R, Conboy V. Return of function and external rotation post-proximal humerus fracture fixation with neutral rotation brace (abstract). Bone and Joint Journal 2013;95(Suppl 9):31.
-
- NCT02073695. Return of function and external rotation post proximal humerus fracture fixation with neutral rotation brace (ROTATE) (Version 2). clinicaltrials.gov/ct2/show/NCT02073695 (first posted 27 February 2014).
-
- NCT02073695. Return of function and external rotation post proximal humerus fracture fixation with neutral rotation brace (ROTATE) (Version 4, submitted 17 July 2019). clinicaltrials.gov/ct2/show/NCT02073695 (first posted 27 February 2014).
Schoch 2019 {published data only}
Shah 2003 {unpublished data only}
-
- Shah N. Brief detail on study status [personal communication]. Contact with H Handoll 1 April 2003.
-
- Shah N. Shoulder function following four part fractures of proximal humerus: A prospective randomised trial for treatment of four part fractures of proximal humerus - conservative vs hemiarthroplasty. In: National Research Register, Issue 1, 2003. Oxford: Update Software.
Shah 2018 {published data only}
-
- Shah PS, Shinde SB. Effect of desensitization methods during the early mobilization phase in post-fracture conditions of upper extremity. Asian Journal of Pharmaceutical and Clinical Research 2018;11(7):93-6.
Torrens 2015 {published data only}
-
- Torrens C. Correction on the status of this trial [personal communication]. Email to: H Handoll 8 July 2020.
-
- Torrens C. Notice of ongoing trial [personal communication]. Email to: H Handoll 4 June 2015.
-
- Torrens C. Ongoing trial details [personal communication]. Email to: H Handoll 10 June 2015.
Wallace 2000 {unpublished data only}
-
- Wallace WA. A prospective randomised trial of the management of displaced surgical neck and displaced shaft fractures of the humerus with the Halder Humeral Nail. In: National Research Register, Issue 3, 2000. Oxford: Update Software.
Wan 2005 {published data only}
-
- Wan L, Wang G-X. Interventional effect of improved mobilization on dysfunction of fractured shoulder joint. Zhongguo Linchuang Kangfu [Chinese Journal of Clinical Rehabilitation] 2005;9(26):10-1.
Wang 2014 {published data only}
-
- Wang Y, Xu B, Yu Z, Dai S, Li F, Wu Y. Comparison of swing shoulder and internal fixation for the treatment of proximal humeral fractures in elderly. Zhongguo Gu Shang [China Journal of Orthopaedics and Traumatology] 2014;27(12):980-5. - PubMed
Warnecke 1999 {published data only}
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- Warnecke J, Jansen T, Oestern H-J. Surgical treatment of proximal humerus fractures [Operative behandlung proximaler humerusfrakturen - AO multicenterstudie]. Deutsche Gesellschaft fur Chirurgie 1999;Suppl Kongressband II:1021-4.
Yang 2006 {published data only}
-
- Yang L, Li B, Pan XY, Li C, Huang JW, Wang ZW, et al. Percutaneous reduction and fixation of osteoporotic fractures for the proximal humerus in a geriatric population. Zhonghua Wai Ke Za Zhi [Chinese Journal of Surgery] 2006;44(12):830-2. - PubMed
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- Yang L. [personal correspondence]. Contact with: H Handoll 9 March 2010.
You 2016 {published data only}
-
- You W, Liu LJ, Chen HX, Xiong JY, Wang DM, Huang JH, et al. Application of 3D printing technology on the treatment of complex proximal humeral fractures (Neer3-part and 4-part) in old people. Orthopaedics & Traumatology, Surgery & Research : OTSR 2016;102(7):897-903. [DOI: 10.1016/j.otsr.2016.06.009] - DOI - PubMed
Zhang 2010 {published data only}
-
- Zhang JH, Di ZL, He ZY, Feng JX, Xu RM. Comparison of humeral head replacement and internal fixation for the treatment of 3 parts and 4 parts fractures of proximal humerus in the elderly. Zhongguo Gu Shang [China Journal of Orthopaedics and Traumatology] 2010;23(6):435-9. - PubMed
Zhao 2017 {published data only}
-
- ChiCTR-INR-17011098. A comparative study on the clinical outcome between MIPPO and conventional ORIF through the deltoid-pectoralis approach for the treatment of proximal humeral fracture in elderly patients. www.chictr.org.cn/showprojen.aspx?proj=18875 (first registered 9 April 2017).
Zhao 2019 {published data only}
-
- Zhao L, Qi YM, Yang L, Wang GR, Zheng SN, Wang Q, et al. Comparison of the effects of proximal humeral internal locking system (PHILOS) alone and PHILOS combined with fibular allograft in the treatment of Neer three- or four-part proximal humerus fractures in the elderly. Orthopaedic Surgery 2019;11(6):1003-12. - PMC - PubMed
References to studies awaiting assessment
Baring 2017 {published data only}
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- Baring T, Desai K. The N-brace trial - a feasibility study (abstract). Shoulder & Elbow 2017;9(1S):S6.
Battistella 2011 {published data only}
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- Battistella F, Oldani M, Tajana MS, Prestamburgo D. Treatment of proximal humerus fractures with locking plate by minimally invasive technique (abstract). Journal of Orthopaedics and Traumatology 2011;12(Suppl):S15-6.
Brorson 2009 {published data only}
-
- Brorson S, Olsen BS, Frich LH, Jensen SL, Johannsen HV, Sorensen AK, et al. Effect of osteosynthesis, primary hemiarthroplasty, and non-surgical management for displaced four-part fractures of the proximal humerus in elderly: a multi-centre, randomised clinical trial. Trials 2009;10:51. - PMC - PubMed
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- Brorson S. Availability of trial data [personal communication]. Email to: H Handoll 24 January 2020.
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- Brorson S. Trial status [personal communication]. Email to; H Handoll 3 February 2015.
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- Brorson S. Trial status [personal communication]. Email to: H Handoll 11 June 2012.
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- Brorson S. Trial status [personal communication]. Email to: H Handoll 22 May 2015.
Chen 2016 {published data only}
-
- Chen H, Ji X, Gao Y, Zhang L, Zhang Q, Liang X, et al. Comparison of intramedullary fibular allograft with locking compression plate versus shoulder hemi-arthroplasty for repair of osteoporotic four-part proximal humerus fracture: consecutive, prospective, controlled, and comparative study. Orthopaedics & Traumatology, Surgery & Research : OTSR 2016;102(3):287-92. - PubMed
Chengjin 2017 {published data only}
-
- Chengjin Z, Haibin H, Shengmei S, Kai L. Comparison of the effect of the fixation of the articular plate and the hollow screw and the band anchorage in the large nodule of humerus. Biomedical Research (India) 2017;28(18):8138-41.
Liu 2011 {published data only}
-
- Liu ZZ, Zhang GM, Ge T, Yang YF. Proximal humeral internal locking system and injectable calcium sulfate graft for the treatment of osteoporotic proximal humeral fractures in elderly patients. Chinese Journal of Tissue Engineering Research 2012;16(51):9679-83.
Liu 2014 {published data only}
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- Liu J, Di J, Zhao C, Yao S, Zhu L, Wang B, et al. Clinical efficacies of different internal fixation materials in the treatment of senile proximal humerus fractures. Zhonghua Yi Xue Za Zhi [Chinese Medical Journal] 2014;94(47):3758-60. - PubMed
Luo 2008 {published data only}
-
- Luo KM, Hou Z, Yang L. Observation on therapeutic effect of electroacupuncture on activity disturbance of the shoulder joint after operation of fracture. Zhongguo Zhen Kiu [Chinese Acupuncture & Moxibustion] 2008;28(10):727-9. - PubMed
NCT01113411 {unpublished data only}
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- NCT01113411. Effectiveness of intensive rehabilitation on shoulder function after proximal humerus fracture (Version 5). clinicaltrials.gov/show/NCT01113411 (first posted 29 April 2010).
-
- NCT01113411. Effectiveness of intensive rehabilitation on shoulder function after proximal humerus fracture (Version 8). clinicaltrials.gov/show/NCT01113411 (first posted 29 April 2010).
NTR3208 {unpublished data only}
-
- NTR3060. Arthroplasty in three- or four-part proximal humerus fracture: hemi or reverse? (renumbered). www.trialregister.nl/trial/3060 (first posted 18 December 2011).
-
- NTR3208. Arthroplasty in three- or four-part proximal humerus fracture: hemi or reverse? www.trialregister.nl/trialreg/admin/rctview.asp?TC=3208 (first posted 18 December 2011).
Paladini 2019 {published data only}
-
- Paladini P, Padolino A, Saporito M, Porcellini G, Merolla G. Clinical and radiographic evaluation of three-four fragments proximal humerus treated with CRF-PEEK or metal plates at two years follow-up. JSES Open Access 2019;3(4):248.
Peng 2017 {published data only}
ProCon 2010 {published and unpublished data}
-
- Den Hartog D, Schep N, Mahabier K, Lordens G, De Zwart A, Verhofstad MH, et al. Hemiarthroplasty versus nonoperative treatment of comminuted proximal humeral fractures: results of the ProCon multicenter randomized clinical trial (abstract). In: Orthopaedic Trauma Association Annual Meeting; 2018 Oct 17–20; Kissimmee (FL). 2018.
-
- Den Hartog D, Van Lieshout EM, Tuinebreijer WE, Polinder S, Van Beeck EF, Breederveld RS, et al. Primary hemiarthroplasty versus conservative treatment for comminuted fractures of the proximal humerus in the elderly (ProCon): a multicenter randomized controlled trial. BMC Musculoskeletal Disorders 2010;11(97):[9 p.]. [DOI: 10.1186/1471-2474-11-97] - DOI - PMC - PubMed
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- NTR1923. Primary hemiarthroplasty versus conservative treatment for comminuted fractures of the proximal humerus in the elderly (ProCon) - A multicenter randomized trial (Version 2: renumbered). www.trialregister.nl/trial/1923 (first posted 30 September 2009).
-
- NTR2040. Primary hemiarthroplasty versus conservative treatment for comminuted fractures of the proximal humerus in the elderly (ProCon) - A multicenter randomized trial. www.trialregister.nl/trialreg/admin/rctview.asp?TC=2040 (first posted 30 September 2009). - PMC - PubMed
Wang 2013 {published data only}
-
- Wang ZH, Deng D, Chen LQ, Zhang WK, Yan HB, Chen XY, et al. Case-control studies on therapeutic effects of combined methods of minimally invasive percutaneous proximal humerus locked osteosynthesis plate with injectable bone for the treatment of proximal humerus fractures in elderly patients. Zhongguo Gu Shang [China Journal of Orthopaedics and Traumatology] 2013;26(5):404-7. - PubMed
Zhang 2016 {published data only}
-
- Zhang AF. Discussion on the effect of TCM fracture three stages therapy in treating proximal humerus fractures. Guang Ming Zhong Yi [Guangming Journal of Traditional Chinese Medicine] 2016;31(10):1422-3.
Zhu 2014 {published data only}
-
- Zhu L, Liu Y, Yang Z, Li H, Wang J, Zhao C, et al. Locking plate fixation combined with iliac crest bone autologous graft for proximal humerus comminuted fracture. Chinese Medical Journal 2014;127(9):1672-6. - PubMed
Z‐TUp Alvarez 2020 {published data only}
-
- NCT02075476. Effectiveness between two surgical techniques for reconstruction of humeral proximal extremity fractures (version 7 updated 1 April 2020). clinicaltrials.gov/ct2/show/NCT02075476 (first posted 3 March 2014).
Z‐TUp Batar 2020 {published data only}
-
- Batar S, Turkmen I, Celik H, Uzer G, Bilsel K. Improved functional outcomes with reverse shoulder arthroplasty compared to hemiarthroplasty after proximal humeral fractures in the elderly [Lepsi funkcni vysledky reverzni artroplastiky ramena ve srovnani s hemiartroplastikou u zlomenin proximalniho humeru u starsich pacientu]. Acta Chirurgiae Orthopaedicae et Traumatologiae Cechoslovaca 2020;87(4):278-84. - PubMed
Z‐TUp Bhayana 2021 {published data only}
-
- Bhayana H, Chouhan DK, Aggarwal S, Prakash M, Patel S, Arora C, et al. Outcomes of plate osteosynthesis for displaced 3-part and 4-part proximal humerus fractures with deltopectoral vs. deltoid split approach. European Journal of Trauma and Emergency Surgery 2021 Jul 31 [Epub ahead of print]. [DOI: 10.1007/s00068-021-01761-6] - DOI - PubMed
Z‐TUp Borda 2019 {published data only}
-
- Borda IM, Irsay L, Ciortea V, Onac I, Ungur R. Pulsed electromagnetic field in rehabilitation of proximal humeral osteoporotic fractures (abstract). Osteoporosis International 2019;30(Suppl 2):S765-6.
Z‐TUp Boyer 2021 {published data only}
-
- Boyer P, Couffignal C, Bahman M, Mylle G, Rousseau MA, Dukan R. Displaced three and four part proximal humeral fractures: prospective controlled randomized open-label two-arm study comparing intramedullary nailing and locking plate. International Orthopaedics 2021;45(11):2917-26. - PubMed
Z‐TUp Hachem 2021 {published data only}
-
- Hachem AI, Rius X, Rodriguez-Bascones K, Catasus M, Matellanes J, Verdalet I, et al. Can anatomic stem angles of 135º in reverse shoulder prosthesis obtain better consolidation rates and clinical outcomes than 155º in RSA fracture? A randomized control trial (Abstract). Journal of Shoulder and Elbow Surgery 2021;30(7):e425-6.
Z‐TUp Izquierdo‐Fernández 2021 {published data only}
-
- Izquierdo-Fernández A, Gómez-Rodríguez M, Urbano-Luque M, García-Carmona M, Quevedo-Reinoso R, Minarro JC. Reverse shoulder arthroplasty in complex fractures of the proximal humerus: results after 7 years of follow-up. Journal of Orthopaedica and Traumatology 2021;22(1):38. [DOI: 10.1186/s10195-021-00597-5] - DOI - PMC - PubMed
Z‐TUp Kröger 2021 {published data only}
-
- Kröger I, Nerz C, Schwickert L, Schölch S, Müßig JA, Studier-Fischer S, et al. Robot-assisted training after proximal humeral fracture: a randomised controlled multicentre intervention trial. Cinical Rehabilitation 2021;35(2):242-52. - PubMed
Z‐TUp Laas 2021 {published data only}
-
- Laas N, Engelsma Y, Hagemans FJ, Hoelen MA, Van Deurzen DF, Burger BJ. Reverse or hemi shoulder arthroplasty in proximal humerus fractures: a single blinded prospective multi-center randomized clinical trial. Journal of Orthopaedic Trauma 2021;35(5):252-8. - PubMed
-
- Li X. In older adults with 3- or 4-part dislocated proximal humeral fractures, reverse shoulder arthroplasty improved anterior elevation and Constant score, but not DASH scores, quality of life, or radiographic outcomes compared with hemiarthroplasty. Journal of Bone and Joint Surgery. American Volume 2021;103(22):2142. - PubMed
Z‐TUp Li 2020 {published data only}
-
- Li G, Wei WF, Liu X, Yang T. Treatment of proximal humeral fractures in elderly patients with intramedullary nail and locking plate. Chung Hua I Hsueh Tsa Chih [Chinese Medical Journal (Taipei)] 2020;100(41):3240-5. - PubMed
Z‐TUp Martinez 2021 {published data only}
-
- Martinez R, Santana F, Pardo A, Torrens C. One versus 3-week immobilization period for nonoperatively treated proximal humeral fractures: a prospective randomized trial. Journal of Bone and Joint Surgery. American Volume 2021;103(16):1491-8. - PubMed
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- Martinez Torregrosa R, Sabtana Perez F, Torens Canovas C. One or three-weeks immobilization period in proximal humeral fractures conservatively treated. Prospective randomized study (abstract). Journal of Shoulder and Elbow Surgery 2021;30(7):e422.
Z‐TUp Monticone 2021 {published data only}ISRCTN17996552
-
- Monticone M, Portoghese I, Cazzaniga D, Liquori V, Marongiu G, Capone A, et al. Task-oriented exercises improve disability of working patients with surgically-treated proximal humeral fractures. A randomized controlled trial with one-year follow-up. BMC Musculoskeletal Disorders 2021;22(1):293. [DOI: 10.1186/s12891-021-04140-9] - DOI - PMC - PubMed
Z‐TUp Vijan 2020 {published data only}
-
- Vijan K, Saoji K. Comparison of functional outcome of fracture proximal humerus treated with open reduction and plate osteosynthesis v/s closed reduction and wire fixation. Indian Journal of Forensic Medicine and Toxicology 2020;14(4):6653-7.
Z‐TUpx ISRCTN85422168 {published data only}
-
- ISRCTN85422168. Comparing the outcomes of non-surgical versus surgical treatment of shoulder fractures with different shoulder replacements (date last edited: 1 September 2021). www.isrctn.com/ISRCTN85422168 (Date applied: 3 July 2021). [DOI: ]
Z‐TUPx NCT04405947 {published data only}
-
- NCT04405947. Influenze of approach in reversed shoulder prosthesis (version 2 updated 30 March 2021). clinicaltrials.gov/show/NCT04405947 (first posted 28 May 2020).
Z‐TUPx NCT04572022 {published data only}
-
- NCT04572022. Impact of mobile health technology application on proximal humerus fracture care practice (version 2 updated 21 July 2021). clinicaltrials.gov/ct2/show/NCT04572022 (first posted 1 October 2020).
Z‐TUpx NCT04651543 {published data only}
-
- NCT04651543. X-ray follow-up in proximal humeral fractures conservatively treated. clinicaltrials.gov/ct2/show/NCT04651543 (first posted: 3 December 2020).
Z‐TUpx NCT04917536 {published data only}
-
- NCT04917536. Comparison of the speed of functional recovery (Constant Score) between two different approaches of humeral nailing in humeral fractures: through the rotator cuff or through the rotator interval split (HUNAAP) (version 2 updated 22 June 2021). clinicaltrials.gov/show/NCT04917536 (first posted 8 June 2021).
Z‐TUpx Song 2020 {published data only}
References to ongoing studies
ChiCTR1900022553 {published data only}
-
- ChiCTR1900022553. Clinical outcomes of three- or four-part complex proximal humerus fractures: reverse total shoulder arthroplasty, hemiarthroplasty versus locking plate fixation. apps.who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR1900022553 (first posted 16 April 2019).
ChiCTR‐IOR‐16008817 {published data only}
-
- ChiCTR-IOR-16008817. Treatment of proximal humeral fractures with locking plates and intramedullary fibular allograft: prospective randomized controlled study (last refreshed 18 April 2017). apps.who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR-IOR-16008817 (first posted 11 July 2016).
DRKS00009990 {published data only}
-
- DRKS00009990. Robot training assistance in humerus fracture – a multicenter, controlled, randomized interventional trial (Version 2). who.int/trialsearch/Trial2.aspx?TrialID=DRKS00009990 (first posted 2 February 2016).
DRKS00011581 {published data only}
-
- DRKS00011581. Clinical, functional and psychosocial outcome of reverse shoulder arthroplasty - a prospective randomized comparison of two types of prostheses after traumatic fracture of the proximal humerus (CEUS #Delta) (Version 1). drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00... (first posted 18 January 2017).
Hakim 2018 {published data only}
-
- Hakim Z, Daw R, Wilkinson P, Brookes-Fazakerley S, Smith M, Kent M, et al. Randomised control trial comparing hemi arthroplasty and reverse polarity shoulder replacement for the treatment of proximal humerus fractures in the elderly - interim analysis (abstract). Shoulder & Elbow 2018;10(3S):S24-5.
Howard 2018 {published data only}
-
- Howard L, Berdusco R, Momoli F, Pollock J, Liew A, Papp S, et al. Open reduction internal fixation vs non-operative management in proximal humerus fractures: a prospective, randomized controlled trial protocol. BMC Musculoskeletal Disorders 2018;19(299):[10 p.]. [DOI: 10.1186/s12891-018-2223-3] - DOI - PMC - PubMed
-
- NCT02362100. Proximal humerus fractures randomized control trial (Version 6). clinicaltrials.gov/ct2/show/NCT02362100 (first posted 12 February 2015).
ISRCTN17996552 {unpublished data only}
-
- ISRCTN17996552. Rehabilitation for humeral fractures in working ages. www.isrctn.com/ISRCTN17996552 (first posted 16 December 2019).
ISRCTN76296703 {published data only}ISRCTN76296703
-
- ISRCTN76296703. Effectiveness and cost-effectiveness of reverse shoulder arthroplasty versus hemiarthroplasty versus non-surgical care for acute 3 and 4 part fractures of the proximal humerus in patients aged over 65 years – the PROFHER-2 randomised trial. isrctn.com/ISRCTN76296703 (first posted 5 April 2018).
Launonen 2019 {published data only}
-
- Launonen AP, Fjalestad T, Laitinen MK, Lahdeoja T, Ekholm C, Wagle T, et al. Nordic Innovative Trials to Evaluate osteoPorotic Fractures (NITEP) Collaboration: the Nordic DeltaCon Trial protocol - Non-operative treatment versus reversed total shoulder arthroplasty in patients 65 years of age and older with a displaced proximal humerus fracture: a prospective, randomised controlled trial. BMJ Open 2019;9(1):e024916. [DOI: 10.1136/bmjopen-2018-024916] - DOI - PMC - PubMed
-
- NCT03531463. Nordic DeltaCon Trial: for displaced proximal humeral fractures in elderly (DeltaCon) (Version 6). clinicaltrials.gov/ct2/history/NCT03531463 (first posted 21 May 2018).
NCT00999193 {unpublished data only}
-
- NCT00999193. Proximal humeral comminuted fractures in the elderly - PERCELE trial (version 8, updated 2 June 2018). clinicaltrials.gov/ct2/show/record/NCT00999193 (first posted 21 October 2009).
-
- NCT00999193. Treatment of comminuted fractures of the proximal humerus. A randomised, controlled study (version 2, updated 26 May 2010). clinicaltrials.gov/ct2/show/record/NCT00999193 (first posted 21 October 2009).
-
- NCT00999193. Treatment of comminuted fractures of the proximal humerus. A randomised, controlled study (version 4, updated 22 January 2012). clinicaltrials.gov/ct2/show/record/NCT00999193 (first posted 21 October 2009).
NCT01524965 {unpublished data only}
-
- NCT01524965. The effect of the timing of postoperative mobilisation after locking plate osteosynthesis of fractures of the surgical neck of the humerus (Version 2). clinicaltrials.gov/ct2/show/NCT01524965 (first posted 2 February 2012).
-
- NCT01524965. The effect of the timing of postoperative mobilisation after locking plate osteosynthesis of fractures of the surgical neck of the humerus (Version 4; sent 3 January 2017). clinicaltrials.gov/ct2/show/NCT01524965 (first posted 2 February 2012).
NCT01557413 {unpublished data only}
-
- Boyer P, Dukan R. Displaced 3- and 4-part proximal humeral fractures: a prospective randomized study comparing intramedullary nail and locking plate (abstract). In: American Academy of Orthopaedic Surgeons Annual Meeting; 2019 Mar 12-16; Las Vegas (CA). 2019.
-
- NCT01557413. Randomised study between intramedullary locking nails and locking plates for treatment of proximal humerus fractures (HUMERUS) (Version 1). clinicaltrials.gov/show/NCT01557413 (first posted 19 March 2012).
-
- NCT01557413. Randomised study between intramedullary locking nails and locking plates for treatment of proximal humerus fractures (HUMERUS) (Version 4, updated 11 March 2015). clinicaltrials.gov/show/NCT01557413 (first posted 19 March 2012).
-
- NCT01557413. Randomised study between intramedullary locking nails and locking plates for treatment of proximal humerus fractures (HUMERUS) (Version 6, updated 20 February 2017). clinicaltrials.gov/show/NCT01557413 (first posted 19 March 2012).
NCT02075476 {unpublished data only}
-
- NCT02075476. The effectiveness between two surgical techniques for reconstruction of humeral proximal extremity fractures or fractures luxation in three or four fragments (version 2 updated 4 March 2014). clinicaltrials.gov/ct2/show/NCT02075476 (first posted 3 March 2014).
-
- NCT02075476. The effectiveness between two surgical techniques for reconstruction of humeral proximal extremity fractures or fractures luxation in three or four fragments (version 6 updated 6 August 2019). clinicaltrials.gov/ct2/show/NCT02075476 (first posted 3 March 2014).
NCT02467803 {published data only}
-
- NCT02467803. Shoulder functional outcomes of patients with proximal humerus fractures: comparison of two different treatment protocol (Version 1). clinicaltrials.gov/ct2/show/NCT02467803 (first posted 10 June 2015).
NCT02913378 {published data only}
-
- NCT02913378. Conservative vs surgical treatment for proximal humerus fractures in the elderly (Version 2; 29 October 2017). clinicaltrials.gov/ct2/show/NCT02913378 (first posted 23 September 2016).
NCT02944058 {published data only}
-
- NCT02944058. Plate fixation versus intramedullary nailing of 3 and 4 part proximal humerus fractures (Version 2; posted 6 July 2018). clinicaltrials.gov/ct2/show/NCT02944058 (first posted 5 October 2016).
NCT03217344 {published data only}
-
- NCT03217344. Conservative treatment of proximal humeral fractures (Version 3). clinicaltrials.gov/ct2/show/NCT03217344 (first posted 14 July 2017).
-
- Torrens C. Information on the trial status [personal communication]. Email to: H Handoll 8 July 2020.
-
- Torrens C. Provision of unpublished abstract and results table for 1 year follow-up [personal communication]. Email to: H Handoll 10 July 2020.
NCT03498859 {published data only}
-
- NCT03498859. Efficacy of physiotherapist-supervised rehabilitation after proximal humerus fracture (Version 3). clinicaltrials.gov/ct2/show/NCT03498859 (first posted 17 April 2018).
NCT03599336 {published data only}
-
- NCT03599336. RSA vs. nonop for 3 & 4-part proximal humerus fractures (Version 3). clinicaltrials.gov/ct2/show/NCT03599336 (first posted 26 July 2018).
NCT03610113 {published data only}
-
- NCT03610113. Reverse or nothing for complex proximal humeral fractures (Version 3). clinicaltrials.gov/ct2/show/NCT03610113 (first posted 1 August 2018).
NCT03694457 {published data only}
-
- NCT03694457. Comparison between anterior approach (deltopectoral) and lateral approach (deltoid splitting) in shoulder reverse arthroplasty for proximal humerus fracture (Version 3). clinicaltrials.gov/ct2/show/NCT03694457 (first posted 3 October 2018).
NCT03786679 {published data only}
-
- NCT03786679. Non-operative treatment in Sweden of proximal humeral fractures (Version 1). clinicaltrials.gov/show/NCT03786679 (first posted 26 December 2018).
NCT04106674 {published data only}
-
- NCT04106674. Two- part proximal humerus - conservative vs operative (Version 1). clinicaltrials.gov/ct2/show/NCT04106674 (first posted 27 September 2019).
NCT04553497 {published data only}
-
- NCT04553497. IFC therapy in proximal humerus fractures (Version 1). clinicaltrials.gov/ct2/show/NCT04553497 (first posted 17 September 2020).
Nerz 2017 {published data only}
-
- NCT03100201. Robotic-assisted training after upper arm fracture (RASTA) (Version 3). clinicaltrials.gov/show/NCT03100201 (first posted 4 April 2017).
-
- Nerz C, Schwickert L, Becker C, Studier-Fischer S, Mußig JA, Augat P. Effectiveness of robot-assisted training added to conventional rehabilitation in patients with humeral fracture early after surgical treatment: protocol of a randomised, controlled, multicentre trial. Trials 2017;18(1):10.1186/s13063-017-2274-z. - PMC - PubMed
NTR3859 {unpublished data only}
-
- Bransen J. Current status of trial [personal communication]. Email to: H Handoll 14 August 2020.
-
- NTR3859. PROMOTION-trial: a PROspective randomized Multicenter trial for the treatment of dislocated 3-part proximal humerus fractures: Open reduction and internal fixaTION versus intramedullary nailing (version; renumbered). trialregister.nl/trial/3859 (first posted 3 June 2013).
-
- NTR4019. PROMOTION-trial: a PROspective randomized Multicenter trial for the treatment of dislocated 3-part proximal humerus fractures: Open reduction and internal fixaTION versus intramedullary nailing. apps.who.int/trialsearch/Trial2.aspx?TrialID=NTR4019 (first posted 3 June 2013).
ReShAPE {published data only}
-
- ACTRN12616000345482. The ReShAPE trial: Reverse Shoulder Arthroplasty for treatment of Proximal humeral fractures in the Elderly (updated version 22 Februrary 2020). anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12616000345482 (first posted 16 March 2016).
-
- Smith GC, Bateman E, Cass B, Damiani M, Harper W, Jones H, et al. Reverse Shoulder Arthroplasty for the treatment of Proximal humeral fractures in the Elderly (ReShAPE trial): study protocol for a multicentre combined randomised controlled and observational trial. Trials 2017;18(1):91. [DOI: 10.1186/s13063-017-1826-6] - DOI - PMC - PubMed
SHeRPA {published data only}21981284
-
- ISRCTN21981284. Comparison of two shoulder replacement methods after trauma. www.isrctn.com/ISRCTN21981284 (first posted 27 January 2015).
-
- ISRCTN21981284. Comparison of two shoulder replacement methods after trauma (record updated 3 December 2015). www.isrctn.com/ISRCTN21981284 (first posted 27 January 2015). [DOI: 10.1186/ISRCTN21981284] - DOI
TPHF {published data only}
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