Cephalomedullary nails versus extramedullary implants for extracapsular hip fractures in older adults
- PMID: 35080771
- PMCID: PMC8791231
- DOI: 10.1002/14651858.CD000093.pub6
Cephalomedullary nails versus extramedullary implants for extracapsular hip fractures in older adults
Abstract
Background: Hip fractures are a major healthcare problem, presenting a substantial challenge and burden to patients, healthcare systems and society. The increased proportion of older adults in the world population means that the absolute number of hip fractures is rising rapidly across the globe. Most hip fractures are treated surgically. This Cochrane Review evaluates evidence for implants used to treat extracapsular hip fractures.
Objectives: To assess the relative effects of cephalomedullary nails versus extramedullary fixation implants for treating extracapsular hip fractures in older adults.
Search methods: We searched CENTRAL, MEDLINE, Embase, Web of Science, the Cochrane Database of Systematic Reviews, Epistemonikos, ProQuest Dissertations & Theses, and the National Technical Information Service in July 2020. We also searched clinical trials databases, conference proceedings, reference lists of retrieved articles, and conducted backward-citation searches.
Selection criteria: We included randomised controlled trials (RCTs) and quasi-RCTs comparing cephalomedullary nails with extramedullary implants for treating fragility extracapsular hip fractures in older adults. We excluded studies in which all or most fractures were caused by a high-energy trauma or specific pathologies other than osteoporosis.
Data collection and analysis: We used standard methodological procedures expected by Cochrane. We collected data for seven critical outcomes: performance of activities of daily living (ADL), delirium, functional status, health-related quality of life, mobility, mortality (reported within four months of surgery as 'early mortality'; and reported from four months onwards, with priority given to data at 12 months, as '12 months since surgery'), and unplanned return to theatre for treating a complication resulting directly or indirectly from the primary procedure (such as deep infection or non-union). We assessed the certainty of the evidence for these outcomes using GRADE. MAIN RESULTS: We included 76 studies (66 RCTs, 10 quasi-RCTs) with a total of 10,979 participants with 10,988 extracapsular hip fractures. The mean ages of participants in the studies ranged from 54 to 85 years; 72% were women. Seventeen studies included unstable trochanteric fractures; three included stable trochanteric fractures only; one included only subtrochanteric fractures; and other studies included a mix of fracture types. More than half of the studies were conducted before 2010. Owing to limitations in the quality of reporting, we could not easily judge whether care pathways in these older studies were comparable to current standards of care. We downgraded the certainty of the outcomes because of high or unclear risk of bias; imprecision (when data were available from insufficient numbers of participants or the confidence interval (CI) was wide); and inconsistency (when we noted substantial levels of statistical heterogeneity or differences between findings when outcomes were reported using other measurement tools). There is probably little or no difference between cephalomedullary nails and extramedullary implants in terms of mortality within four months of surgery (risk ratio (RR) 0.96, 95% CI 0.79 to 1.18; 30 studies, 4603 participants) and at 12 months (RR 0.99, 95% CI 0.90 to 1.08; 47 studies, 7618 participants); this evidence was assessed to be of moderate certainty. We found low-certainty evidence for differences in unplanned return to theatre but this was imprecise and included clinically relevant benefits and harms (RR 1.15, 95% CI 0.89 to 1.50; 50 studies, 8398 participants). The effect estimate for functional status at four months also included clinically relevant benefits and harms; this evidence was derived from only two small studies and was imprecise (standardised mean difference (SMD) 0.02, 95% CI -0.27 to 0.30; 188 participants; low-certainty evidence). Similarly, the estimate for delirium was imprecise (RR 1.22, 95% CI 0.67 to 2.22; 5 studies, 1310 participants; low-certainty evidence). Mobility at four months was reported using different measures (such as the number of people with independent mobility or scores on a mobility scale); findings were not consistent between these measures and we could not be certain of the evidence for this outcome. We were also uncertain of the findings for performance in ADL at four months; we did not pool the data from four studies because of substantial heterogeneity. We found no data for health-related quality of life at four months. Using a cephalomedullary nail in preference to an extramedullary device saves one superficial infection per 303 patients (RR 0.71, 95% CI 0.53 to 0.96; 35 studies, 5087 participants; moderate-certainty evidence) and leads to fewer non-unions (RR 0.55, 95% CI 0.32 to 0.96; 40 studies, 4959 participants; moderate-certainty evidence). However, the risk of intraoperative implant-related fractures was greater with cephalomedullary nails (RR 2.94, 95% CI 1.65 to 5.24; 35 studies, 4872 participants; moderate-certainty evidence), as was the risk of later fractures (RR 3.62, 95% CI 2.07 to 6.33; 46 studies, 7021 participants; moderate-certainty evidence). Cephalomedullary nails caused one additional implant-related fracture per 67 participants. We noted no evidence of a difference in other adverse events related or unrelated to the implant, fracture or both. Subgroup analyses provided no evidence of differences between the length of cephalomedullary nail used, the stability of the fracture, or between newer and older designs of cephalomedullary nail.
Authors' conclusions: Extramedullary devices, most commonly the sliding hip screw, yield very similar functional outcomes to cephalomedullary devices in the management of extracapsular fragility hip fractures. There is a reduced risk of infection and non-union with cephalomedullary nails, however there is an increased risk of implant-related fracture that is not attenuated with newer designs. Few studies considered patient-relevant outcomes such as performance of activities of daily living, health-related quality of life, mobility, or delirium. This emphasises the need to include the core outcome set for hip fracture in future RCTs.
Trial registration: ClinicalTrials.gov NCT01238068.
Copyright © 2022 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Conflict of interest statement
SL has no known conflicts of interest.
RM has no known conflicts of interest.
JG has no known conflicts of interest.
MP has received and may continue to receive financial payment from manufacturing companies of orthopaedic implants, for attending meetings organised by these companies and for advising on the design and use of hip fracture implants. He has remained independent of study selection decisions, risk of bias assessments, and data extraction of any of the studies on which he is an author, co‐applicant or has had an advisory role.
XG is funded by a National Institute for Health Research Clinician Scientist Grant. Further funding from industry and charitable grants are and have been made available to his institution. All decisions relating to the design, conduct, analysis, write‐up, and publication of research are independent of these funders. He has ongoing expert consultancy with several companies; none involve the development of any implant for use in hip fracture care. He has remained independent of study selection decisions, risk of bias assessments, and data extraction of any of the studies on which he is an author, co‐applicant, or has had an advisory role.
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Update of
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Gamma and other cephalocondylic intramedullary nails versus extramedullary implants for extracapsular hip fractures in adults.Cochrane Database Syst Rev. 2010 Sep 8;(9):CD000093. doi: 10.1002/14651858.CD000093.pub5. Cochrane Database Syst Rev. 2010. Update in: Cochrane Database Syst Rev. 2022 Jan 26;1:CD000093. doi: 10.1002/14651858.CD000093.pub6. PMID: 20824825 Updated.
References
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O'Brien 1995 {published and unpublished data}
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Pahlpatz 1993 {published data only}
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- Pahlplatz PVM, Langius FB.Comparing the Gamma nail and the Dynamic Hip Screw in the treatment of pertrochanteric fractures. Preliminary results of a prospective randomised study. In: Marti RK, Dunki Jacobs PB, editors(s). Proximal femoral fractures. Operative technique and complications. Vol. 2. London, UK: Medical Press Limited, 1993:475-80.
Pajarinen 2005 {published data only}
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- Pajarinen J.personal communication 24 February 2005.
Papasimos 2005 {published data only}
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- Papasimos S, Koutsojannis CM, Panagopoulos A, Megas P, Lambiris E.A randomised comparison of AMBI, TGN and PFN for treatment of unstable trochanteric fractures. Archives of Orthopaedic and Trauma Surgery 2005;125(7):462-8. [PMID: ] - PubMed
Park 1998 {published data only}
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Parker 2012 {published data only}
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- Parker MJ, Bowers TR, Pryor GA.Sliding hip screw versus the Targon PF nail in the treatment of trochanteric fractures of the hip; a randomised trial of 600 fractures. The Journal of Bone & Joint Surgery 2012;94(3):391-7. [PMID: ] - PubMed
Parker 2017 {published data only}
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- Parker M.Intramedullary fixation with a third generation nail versus the sliding hip screw for trochanteric hip fractures; a randomised trial of 400 patients. Orthopaedic Proceedings January 2011;Vol. 93-B:22.
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- Parker M.Intramedullary fixation with a third generation nail versus the sliding hip screw for trochanteric hip fractures: a randomised trial of 400 patients. Orthopaedic Proceedings 2010;Vol. 92-B:556.
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- Parker MJ, Cawley S.Sliding hip screw versus the Targon PFT nail for trochanteric hip fractures. Bone and Joint Journal 2017;99(9):1210-5. [PMID: ] - PubMed
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- Parker MJ.Sliding hip screw versus intramedullary nail for trochanteric hip fractures; a randomised trial of 1000 patients with presentation of results related to fracture stability. Injury 2017;48(12):2762-7. [PMID: ] - PubMed
Pelet 2001 {published data only}
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Radford 1993 {published data only}
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- Radford PJ, Needoff M, Webb JK.The Gamma nail compared to the dynamic hip screw for pertrochanteric fractures of the femur [abstract]. Journal of Bone and Joint Surgery. British Volume 1992;74 Suppl 2:133-4.
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- Radford PJ, Needoff M.Intramedullary or extramedullary fixation for pertrochanteric fractures of the femur? [abstract]. Journal of Bone and Joint Surgery. British Volume 1992;74(Suppl 3):281.
Rahme 2007 {published data only}
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- Harris I, Rahme D.A prospective randomised controlled trial of subtrochanteric femur fractures treated with a proximal femoral nail compared to a 95-degree blade plate [abstract]. Journal of Bone and Joint Surgery. British Volume 2005;87(Suppl 3):310-1.
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- Rahme DM, Harris IA.Intramedullary nailing versus fixed angle blade plating for subtrochanteric femoral fractures: a prospective randomised controlled trial. Journal of Orthopaedic Surgery 2007;15(3):278-81. [PMID: ] - PubMed
Raimondo 2012 {published data only}
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Reindl 2015 {published data only}
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- NCT00597779.Randomised comparison of 2 fixation techniques for unstable intertrochanteric hip fractures (EMvsIM). clinicaltrials.gov/show/NCT00597779 (first received 18 January 2008).
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- Reindl R, Harvey EJ, Berry GK, Rahme E.Intramedullary versus extramedullary fixation for unstable intertrochanteric fractures: a prospective randomized controlled trial. Journal of Bone and Joint Surgery. American volume 2015;97:1905-12. [PMID: ] - PubMed
Sadowski 2002 {published and unpublished data}
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- Sadowski C, Lubbeke A, Saudan M, Riand N, Stern R, Hoffmeyer P.Treatment of reverse oblique and transverse intertrochanteric fractures with use of an intramedullary nail or a 95 degree screw-plate. Journal of Bone and Joint Surgery. American Volume 2002;84(3):372-81. [PMID: ] - PubMed
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Sanders 2017 {published data only}
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- Sanders D, Bryant D, Tieszer C, Lawendy AR, MacLeod M, Papp S et al.Multicenter randomized control trial comparing a novel intramedullary device (InterTAN) versus conventional treatment (Sliding Hip Screw) of geriatric hip fractures. Journal of Orthopaedic Trauma 2017;31(1):1-8. [PMID: ] - PubMed
Saudan 2002 {published and unpublished data}
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- Saudan M, Lubbeke A, Sadowski C, Riand N, Stern R, Hoffmeyer P.Pertrochanteric fractures: is there an advantage to an intramedullary nail? A randomized, prospective study of 206 patients comparing the dynamic hip screw and proximal femoral nail. Journal of Orthopaedic Trauma 2002;16(6):386-93. [PMID: ] - PubMed
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- Saudan M, Lubecke A, Sadowski Ch, Riand N, Stern R, Hoffmeyer P.Is there an indication for intramedullary fixation of intertrochanteric fractures? [abstract]. In: European Federation of National Associations of Orthopaedics and Traumatology; 2001 Jun 1-7; Rhodes (Greece). 2001.
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- Saudan M, Lubecke-Wolff A, Sadowski C, Riand N, Hoffmeyer P.The proximal femoral nail (PFN) and the dynamic hip screw (DHS): a prospective clinical trial [abstract]. Journal of Bone and Joint Surgery. British Volume 1999;81 Suppl 2:163.
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- Stern RE, Sadowski C, Lubbeke A, Saudan M, Riand N, Hoffmeyer P.Pertrochanteric fractures: is there an advantage to an intramedullary nail? [abstract]. In: Annual Meeting of the Orthopaedic Trauma Association; 2001 Oct 18-20; San Diego (California). Orthopaedic Trauma Association, 2001.
Sharma 2018 {published data only}
Singh 2017 {published data only}
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- Singh AK, Narsaria N, Arun GR, Srivastava V.Treatment of unstable trochanteric femur fractures: Proximal Femur Nail versus Proximal Femur Locking Compression Plate. American Journal of Orthopedics 2017;46(2):E116-23. [PMID: ] - PubMed
Singh 2019 {published data only}
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- Singh NK.A prospective randomized control study comparing functional and radiological outcome in elderly patients with type 31 a1 and a2 intertrochateric fractures treated by proximal femoral nail anti-rotation (pfna) vs dynamic hip screw (dhs). Ann Arbor All India Institute of Medical Sciences, New Delhi (India) 2016;11004638:117.
Song 2011 {published data only}
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- Song W, Chen Y, Shen H, Yuan T, Zhang C, Zeng B.Biochemical markers comparison of dynamic hip screw and gamma nail implants in the treatment of stable intertrochanteric fracture: a prospective study of 60 patients. Journal of International Medical Research 2011;39(2):822-9. [PMID: ] - PubMed
Tao 2013 {published data only}
Utrilla 2005 {published data only}
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- Utrilla AL, Reig JS, Munoz FM, Tufanisco CB.Trochanteric Gamma nail and compression hip screw for trochanteric fractures: a randomized, prospective, comparative study in 210 elderly patients with a new design of the Gamma nail. Journal of Orthopaedic Trauma 2005;19(4):229-33. [PMID: ] - PubMed
Varela‐Egocheaga 2009 {published data only}
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- Varela-Egocheaga JR, Iglesias-Colao R, Suarez-Suarez MA, Fernandez-Villan M, Gonzalez-Sastre V, Murcia-Mazon A.Minimally invasive osteosynthesis in stable trochanteric fractures: a comparative study between Gotfried percutaneous compression plate and Gamma 3 intramedullary nail. Archives of Orthopaedic and Trauma Surgery 2009;129(10):1401-7. [PMID: ] - PubMed
Verettas 2010 {published data only}
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- Verettas D-AJ, Ifantidis P, Chatzipapas CN, Drosos GI, Xarchas KC, Chloropoulou P, et al.Systematic effects of surgical treatment on hip fractures: gliding screw-plating vs intramedullary nailing. Injury 2010;41(3):279-84. [PMID: ] - PubMed
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- Verettas DAJ.personal communication 25 May 2010.
Wang 2019 {published data only}
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- Wang B, Liu Q, Liu Y, Jiang R.Comparison of proximal femoral nail antirotation and dynamic hip screw internal fixation on serum markers in elderly patients with intertrochanteric fractures. Journal of the College of Physicians and Surgeons Pakistan 2019;29(7):644-8. [PMID: ] - PubMed
Xu 2010 {published data only}
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- Xu YZ, Geng DC, Mao HQ, Zhu XS, Yang HL.A comparison of the proximal femoral nail antirotation device and dynamic hip screw in the treatment of unstable pertrochanteric fracture. The Journal of International Medical Research 2010;38:1266-75. [PMID: ] - PubMed
Xu 2018 {published data only}
Yamauchi 2014 {published data only}
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- Yamauchi K, Fushimi K, Shirai G, Fukuta M.Comparison of functional recovery in the very early period after surgery between plate and nail fixation for correction of stable femoral intertrochanteric fractures: a controlled clinical trial of 18 patients. Geriatric Orthopaedic Surgery & Rehabilitation 2014;5(2):63-8. [PMID: ] - PMC - PubMed
Zehir 2015 {published data only}
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- Zehir S, Zehir R, Azboy I, Haykir N.Proximal femoral nail antirotation against dynamic hip screw for unstable trochanteric fractures; a prospective randomized comparison. European Journal of Trauma & Emergency Surgery 2015;41(4):393-400. [PMID: ] - PubMed
Zhou 2012 {published data only}
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- Zhou F, Zhang Z, Yang H, Tian Y, Ji HQ, Guo Y, et al.Less invasive stabilization system (LISS) versus Proximal Femoral Nail Anti-rotation (PFNA) in treating proximal femoral fractures: a prospective randomized study. Journal of Orthopaedic Trauma 2012;26(3):155-62. [PMID: ] - PubMed
Zou 2009 {published data only}
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- Zou J, Xu Y, Yang H.A comparison of proximal femoral nail antirotation and dynamic hip screw devices in trochanteric fractures. Journal of International Medical Research 2009;37(4):1057-64. [PMID: ] - PubMed
References to studies excluded from this review
ACTRN12608000162314 {published and unpublished data}
-
- ACTRN12608000162314.Prospective randomised pilot study comparing the dynamic hip screw and intramedullary gamma nail regarding the treatment of intertrochanteric hip fracture [Prospective randomised pilot study comparing the dynamic hip screw and intramedullary gamma nail regarding functional recovery following the treatment of intertrochanteric hip fractures]. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=82348 (first received 1 August 2008).
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- Molnar R.Trial status [personal communication]. Email to: R Macey 3 August 2015.
Ahmad 2011 {unpublished data only}
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- Ahmad M, Bajwa A, Patil S, Bhattacharya R, Nanda R, Danjoux G, et al.Haemodynamic changes during fixation of extracapsular proximal femoral fractures: RCT comparing compression hip screw versus intramedullary hip screw [abstract]. Journal of Bone and Joint Surgery. British Volume 2011;93(Suppl III):313-4.
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- Ahmad M, Bhattacharya R, Nanda R, Bajwa A, Danjoux G, Hui AC.An RCT comparing haemodynamic changes during the fixation of extracapsular proximal femoral fractures using the compression hip screw versus the intramedullary hip screw [abstract]. The Surgeon: Journal of the Royal Colleges of Surgeons of Edinburgh and Ireland 2005;3(Suppl 3):S10.
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- Ahmad M.Randomised controlled trial to compare the magnitude and incidence of haemodynamic changes during fixation of extracapsular fractures of the neck of femur using the compression hip screw versus the intramedullary hip screw. National Research Register Archive. nihr.ac.uk/Profiles/NRR.aspx?Publication_ID=N0227149002 (accessed 7 June 2010).
Gupta 2012 {published data only}
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- Gupta A, Cooke C, Wilkinson M, Grazette A.Randomised control trial comparing long cephlocondylic nail vs compression hip screw for treatment of intertrochanteric hip fractures (abstract). Journal of Bone and Joint Surgery. British Volume 2012;94(Suppl XLI):117.
Lee 2007 {published data only}
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- Lee P-C, Hsieh P-H, Yu S-W, ShIao C-W, Kao H-K, Wu C-C.Biologic plating versus intramedullary nailing for comminuted subtrochanteric fractures in young adults: a prospective, randomised study of 66 cases. Journal of Trauma-Injury Infection & Critical Care 2007;63(6):1283-91. [PMID: ] - PubMed
NCT00686023 {published data only}
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- NCT00686023.Comparing Surgical Techniques for CRIF of Pertrochanteric Fractures. clinicaltrials.gov/ct2/show/NCT00686023 (first received 29 May 2008).
NCT00736684 {published data only}
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- NCT00736684.Proximal Femoral Nail Antirotation™ (PFNA) versus Gamma Nail 3™ (Gamma3) for intramedullary nailing of unstable trochanteric fractures (PROGAINT-ES). clinicaltrials.gov/ct2/show/NCT00736684 (first received 18 August 2008).
NCT01173744 {published data only}
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- NCT01173744.Comparison of Gamma nail versus Dynamic Hip Screw for the treatment of unstable intertrochanteric fractures. clinicaltrials.gov/ct2/show/NCT01173744 (first received 2 August 2010).
NCT01238068 {unpublished data only}
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- NCT01238068.Comparison of the results of treatment by Gamma nail versus dynamic hip screw for unstable intertrochanteric hip fractures. clinicaltrials.gov/show/NCT01238068 (first received 10 November 2010).
NCT03065101 {published data only}
-
- NCT03065101.Trigen InterTAN vs Sliding Hip Screw RCT. clinicaltrials.gov/ct2/show/NCT03065101 (first received 27 February 2017).
References to studies awaiting assessment
NCT01380444 {unpublished data only}
-
- NCT01380444.Intramedullary nail versus sliding hip screw inter-trochanteric evaluation (INSITE). clinicaltrials.gov/show/NCT01380444 (first received 27 June 2011).
-
- Schemitsch EH.Intramedullary nailing versus sliding hip screw intertrochanteric evaluation: the INSITE Trial. In: Orthopaedic Trauma Association Annual Meeting; 2020 Oct 21-24; virtual meeting. ota.org/sites/files/abstracts/2020/OTA AM20 Paper Schemitsch.pdf, 2021.
NCT02788994 {published data only}
-
- NCT02788994.Stabilization of fresh unilateral unstable pertrochanteric hip fracture (PET). clinicaltrials.gov/show/NCT02788994 (first received 2 June 2016).
NCT03849014 {published data only}
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- NCT03849014.Comparison of biochemical changes in patients with trochanteric region fracture fixation with DHS versus PFN. clinicaltrials.gov/show/NCT03849014 (first received 21 February 2019).
REGAIN 2008 {published data only}
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- Bhandari M, Bojan A, Eckholm C, Brink O, Adili A, Sprague S, et al.Functional outcomes following intramedullary nailing of trochanteric hip fractures: a pilot multicentre, randomised controlled trial (abstract). Journal of Bone and Joint Surgery. British Volume 2011;93 Suppl IV:574.
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- NCT00555945.Re-evaluation of Gamma3 intramedullary nails in hip fracture (REGAIN). clinicaltrials.gov/ct2/show/NCT00555945 (first received 9 November 2007).
References to ongoing studies
IRCT20141209020258N80 {published data only}
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- IRCT20141209020258N80.Comparison proximal femoral nailing (PFN) versus dynamic hip screw(DHS) in intertrochanteric fracture. en.irct.ir/trial/31176 (first received 11 June 2018).
NCT03906032 {published data only}
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- NCT03906032.Comparison of sliding hip screw to intra medullary nailing in the treatment of intertrochanteric hip fracture. clinicaltrials.gov/ct2/show/NCT03906032 (first received 8 April 2019).
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