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. 2019 Jan 29;9(1):e024916.
doi: 10.1136/bmjopen-2018-024916.

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

Antti P Launonen  1 , Tore Fjalestad  2 , Minna K Laitinen  1 , Tuomas Lähdeoja  3 , Carl Ekholm  4 , Tone Wagle  2 , Ville M Mattila  1 ; NITEP-group
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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

Antti P Launonen et al. BMJ Open. .

Abstract

Introduction: The proximal humerus fracture (PHF) is one of the most common fractures in the elderly. The majority of PHFs are treated non-operatively, while 15%-33% of patients undergo surgical treatment. Recent randomised controlled trial (RCT) and meta-analyses have shown that there is no difference in outcome between non-operative treatment and locking plate or hemi-arthroplasty. During the past decade, reverse total shoulder arthroplasty (RTSA) has gained popularity in the treatment of PHF, although there is a lack of RCTs comparing RTSA to non-operative treatment.

Methods: This is a prospective, single-blinded, randomised, controlled, multicentre and multinational trial comparing RTSA with non-operative treatment in displaced proximal humeral fractures in patients 65-85 years. The primary outcome in this study is QuickDASH-score measured at 2 years. Secondary outcomes include visual analogue scale for pain, grip strength, Oxford shoulder score, Constant score and the number of reoperations and complications.The hypothesis of the trial is that operative treatment with RTSA produces better outcome after 2 and 5 years measured with QuickDASH.

Ethics and dissemination: In this protocol, we describe the design, method and management of the Nordic DeltaCon trial. The ethical approval for the trial has been given by the Regional Committee for Medical and Health Research Ethics, Norway. There have been several examples in orthopaedics of innovations that result in failure after medium-term follow-ups . In order to prevent such failures and to increase our knowledge of RSTA, we feel a large-scale study of the effects of the surgery on the outcome that focuses on the complications and reoperations is warranted. After the trial 2-year follow-up, the results will be disseminated in a major orthopaedic publication.

Trial registration number: NCT03531463; Pre-Results.

Keywords: adult orthopaedics; musculoskeletal disorders; shoulder; trauma management.

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Conflict of interest statement

Competing interests: None declared.

References

    1. Handoll H, Brealey S, Rangan A, et al. . The ProFHER (PROximal Fracture of the Humerus: evaluation by randomisation) trial - a pragmatic multicentre randomised controlled trial evaluating the clinical effectiveness and cost-effectiveness of surgical compared with non-surgical treatment for proximal fracture of the humerus in adults. Health Technol Assess 2015;19:1–280. 10.3310/hta19240 - DOI - PMC - PubMed
    1. Fjalestad T, Hole MØ, Jørgensen JJ, et al. . Health and cost consequences of surgical versus conservative treatment for a comminuted proximal humeral fracture in elderly patients. Injury 2010;41:599–605. 10.1016/j.injury.2009.10.056 - DOI - PubMed
    1. Lohmander LS, Roos EM. The evidence base for orthopaedics and sports medicine: scandalously poor in parts. Br J Sports Med 2016;50:564–5. 10.1136/bjsports-2016-g7835rep - DOI - PubMed
    1. Huttunen TT, Launonen AP, Pihlajamäki H, et al. . Trends in the surgical treatment of proximal humeral fractures - a nationwide 23-year study in Finland. BMC Musculoskelet Disord 2012;13:261 10.1186/1471-2474-13-261 - DOI - PMC - PubMed
    1. Mattila VM, Huttunen TT, Sillanpää P, et al. . Significant change in the surgical treatment of distal radius fractures: a nationwide study between 1998 and 2008 in Finland. J Trauma 2011;71:939–43. DIscussion 942-3 10.1097/TA.0b013e3182231af9 - DOI - PubMed

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