Background: Treatment 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/design: This 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.
Discussion: This 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 number: ClinicalTrials.gov Identifier: NCT01737060.