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)

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.

Reverse Shoulder Arthroplasty Is Superior to Plate Fixation at 2 Years for Displaced Proximal Humeral Fractures in the Elderly

“…The study was registered with ClinicalTrials.gov (NCT01737060). The study protocol was published in 2014 17 .…”

“…All surgical procedures were performed in the beach-chair position, using a deltopectoral approach. A detailed description of both operative techniques is featured in the methods section of the published protocol 17 . Postoperatively, all patients received a standardized rehabilitation program according to the allocated group.…”

Calcar screws and adequate reduction reduced the risk of fixation failure in proximal humeral fractures treated with a locking plate: 190 patients followed for a mean of 3 years

“…In fractures with medial comminution, calcar screws, medialization and impaction of the humeral shaft onto the humeral head or both, may restore a medial support [ 10 ]. Alternatively, some authors advocate the use of an additional medial buttress plate [ 18 ], allograft reinforcement [ 19 , 20 ], bone substitution [ 9 , 21 ] or intramedullary nailing [ 22 – 24 ].…”

“…Still, RTSA may be a relevant choice for the primary surgical treatment of displaced PHFs among patients aged 65 years and above with poor rotator cuff status and high risk of healing complications [ 9 , 39 ]. However, there are few level I trials, and two ongoing randomised controlled multicentre trials compare treatment of PHFs with locking plate versus RTSA [ 18 ] and locking plate versus RTSA or versus conservative treatment [ 40 ]. Hopefully, these trials will prove high-level evidence and guide the surgical treatment of proximal humeral fractures accordingly.…”

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

“…Additionally, the complication rate with RTSA was found to be lower than for HA, and thus we decide that it would be safe to set the lower age limit at 65 years. In another RTSA trial that included patients aged 65 years or over,21 the number of adverse events (AEs) after interim analysis was less than reported in the literature, which also supports the lower age limit.…”