Abstract
BackgroundTreatment for displaced proximal humeral fractures is still under debate. Few studies exist at the highest level of evidence. Although reversed total shoulder prosthesis has gained popularity and showed promising results in the treatment for proximal humeral fractures in the elderly patients, no randomized controlled trials exist to the authors’ knowledge.Methods/DesignThis study is a randomized semi-blinded controlled multicenter trial designed according to the Consort statement and the recommendations given by the Cochrane reviewers for proximal humeral fractures. The study will investigate whether a reversed total shoulder prosthetic replacement gain better functional outcome compared to open reduction and internal fixation using an angular stable plate in displaced three- and four parts proximal humeral fractures after two and five years follow-up.Participants are aged 65–85 admitted in seven different hospitals with a displaced proximal humeral fracture according to AO-OTA type 11-B2 or 11-C2. The intervention group is surgical treatment using a reversed total shoulder prosthesis (Delta X-tend) compared to open reduction and internal fixation with an angular stable plate (Philos) and thread cerclage in the control group. 60 patients will be randomized to each group.The primary outcome is shoulder function (Constant score). Secondary outcomes will be patient self-assessment form (Oxford shoulder score), a quality of life questionnaire (15D score) and resource implications (cost-effectiveness). Follow-ups take place at 3, 6, 12 and 24 months, and five years. The trial design is semi-blinded with blinded physiotherapists performing the functional testing of patients at all follow-ups.Randomization to treatment groups is electronic online, by independent supervisor (web-CRF). The recruitment of patients started at January 1.st 2013. Inclusion of 120 patients during three years is expected.DiscussionThis semiblinded trial include a high number of patients compared to existing randomized trials in this field. To our knowledge and according to ClinicalTrials.gov, this is the first study that compare these two treatments for a displaced proximal humeral fracture in elderly patients. This may provide important information to help the surgeon to decide the best treatment in the future.Trial registration numberClinicalTrials.gov Identifier: NCT01737060Electronic supplementary materialThe online version of this article (doi:10.1186/1471-2474-15-323) contains supplementary material, which is available to authorized users.
Highlights
Treatment for displaced proximal humeral fractures is still under debate
This semiblinded trial include a high number of patients compared to existing randomized trials in this field
Hypothesis We aim to establish if treatment with reverse total shoulder artroplasty (RTSA) gain better functional outcome according to the Constant shoulder score compared to open reduction and internal fixation with an angular stable implant at two and five years of follow-up [65,66]
Summary
Treatment for displaced proximal humeral fractures is still under debate. Few studies exist at the highest level of evidence. Reversed total shoulder prosthesis has gained popularity and showed promising results in the treatment for proximal humeral fractures in the elderly patients, no randomized controlled trials exist to the authors’ knowledge. Treatment for displaced proximal humeral fractures is still under debate several decades after the first recommendations for “modern treatment principles” were given by Neer [1,2]. According to the last Cochrane review, including 16 small randomized trials at the highest level of evidence and a total number of 801 patients, best treatment has not yet been ruled out. Our intention is to design a randomized study between two methods of surgical treatment meeting the recommendations given by these authors New trials should meet the criteria for design and reporting according to the Consort statement [3,4].
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