Clinical investigation for displaced proximal humeral fractures in the elderly: a randomized study of two surgical treatments: reverse total prosthetic replacement versus angular stable plate Philos (The DELPHI-trial).

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.

Displaced proximal humeral fractures: operative versus non-operative treatment--a 2-year extension of a randomized controlled trial.

BACKGROUND: Surgical treatment for displaced proximal humeral fractures is widely used. However, there are very few randomized controlled studies comparing surgical treatment to conservative treatment, and the evidence is debated. The aim of this study was to describe patients with displaced proximal humeral fractures in a 2-years extension of a randomized controlled trial, their functional outcome and quality of life. MATERIALS AND METHODS: Patients from a single-center randomized controlled study of fifty patients aged 60 or above with displaced proximal humeral fracture (AO/OTA group B2 or C2) were randomized to surgical or conservative treatment. Surgery was performed with an angular stable implant. The main outcome was Constant score at 2-year follow-up. Secondary outcomes were an ASES self-assessment form, the 15D quality of life assessment and radiographs at 2 years. RESULTS: A marked improvement of shoulder function and health-related quality of life for both surgically and conservatively treated patients occurs between 6 and 12 months. Almost no change was observed between 1 and 2 year. There were no significant differences between the two treatments at 2-year follow-up. CONCLUSIONS: In this randomized controlled trial, surgical treatment proved no better results than conservative treatment for patients with displaced proximal humeral fracture at 2-year follow-up.