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External validity in a multicenter randomized clinical trial of proximal humeral fractures: the DelPhi trial.

ABSTRACT:

Background

Randomized controlled trials (RCT) are regarded as the gold standard for effect evaluation in clinical interventions. However, RCTs may not produce relevant results to all patient groups. We aimed to assess the external validity of a multicenter RCT (DelPhi trial).

Methods

The DelPhi RCT investigated whether elderly patients with displaced proximal humeral fractures (PHFs) receiving reversed total shoulder prosthetic replacement (RTSA) gained better functional outcomes compared to open reduction and internal fixation (ORIF) using an proximal humerus locking plate (PHILOS). Eligible patients were between 65 and 85 years old with severely displaced 11-B2 or 11-C2 fractures (AO/OTA-classification, 2007). We compared baseline and follow-up data of patients for two of the seven hospitals that were included in the DelPhi trial (n = 54) with non-included patients (n = 69). Comparisons were made based on reviewing medical records regarding demographic, health and fracture parameters.

Results

Forty-four percent of the eligible patients were included in the DelPhi trial. Comparing included and non-included patients indicated higher incidences of serious heart disease (P = 0.044) and a tendency toward higher tobacco intake (P = 0.067) in non-included patients. Furthermore, non-included patients were older (P = 0.040) and had higher ASA classification (P < 0.001) and were in more need for resident aid (in-home assistance) (P = 0.022) than included patients. The cause of PHF was more frequently related to fall indoors in non-included vs. included patients (P = 0.018) and non-included patients were more prone to other concomitant fractures (P = 0.004). Having concomitant fractures was associated with osteoporosis (P = 0.014). We observed no significant differences in rates of complications or deaths between included and non-included patients within 3 months after treatment. In descending order, non-included patients were treated conservatively, with PHILOS, RTSA, anatomic hemi-prothesis or an alternative type of ORIF. RTSA was the preferred treatment choice for C2-type fractures (P < 0.001).

Conclusions

Results from the DelPhi RCT may not directly apply to older PHFs patients with lower health status or concomitant fractures.

Level of evidence

Level 4.

SUBMITTER: Tallay E

PROVIDER: S-EPMC8783856 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description: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: NCT01737060.

Project description:BackgroundAlmost one-third of patients with proximal humeral fractures are treated surgically, and the number is increasing. When surgical treatment is chosen, there is sparse evidence on the optimum method. The DelPhi (Delta prosthesis-PHILOS plate) trial is a clinical trial comparing 2 surgical treatments. Our hypothesis was that reverse total shoulder arthroplasty (TSA) yields better clinical results compared with open reduction and internal fixation (ORIF) using an angular stable plate.MethodsThe DelPhi trial is a randomized controlled trial comparing reverse TSA with ORIF for displaced proximal humeral fractures (OTA/AO types 11-B2 and 11-C2) in elderly patients (65 to 85 years of age). The primary outcome measure was the Constant score at a 2-year follow-up. The secondary outcome measures included the Oxford Shoulder Score and radiographic evaluation. Results were reported as the mean difference with 95% confidence interval (CI). The intention-to-treat principle was applied for crossover patients.ResultsThere were 124 patients included in the study. At 2 years, the mean Constant score was 68.0 points (95% CI, 63.7 to 72.4 points) for the reverse TSA group compared with 54.6 points (95% CI, 48.5 to 60.7 points) for the ORIF group, resulting in a significant mean difference of 13.4 points (95% CI, 6.2 to 20.6 points; p < 0.001) in favor of reverse TSA. When stratified for fracture classification, the mean score was 69.3 points (95% CI, 63.9 to 74.7 points) for the reverse TSA group and 50.6 points (95% CI, 41.9 to 59.2 points) for the ORIF group for type-C2 fractures, which yielded a significant mean difference of 18.7 points (95% CI, 9.3 to 28.2 points; p < 0.001). In the type-B2 fracture group, the mean score was 66.2 points (95% CI, 58.6 to 73.8 points) for the reverse TSA group and 58.5 points (95% CI, 49.6 to 67.4 points) for the ORIF group, resulting in a nonsignificant mean difference of 7.6 points (95% CI, -3.8 to 19.1 points; p = 0.19).ConclusionsAt a 2-year follow-up, the data suggested an advantage of reverse TSA over ORIF in the treatment of displaced OTA/AO type-B2 and C2 proximal humeral fractures in elderly patients.Level of evidenceTherapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Project description:Management of distal humeral fractures remains to be one of the most challenging aspects in trauma surgery. Low profile plating systems with variable angle screw fixation represent a crucial advancement to the established angular stable locking plates with considerable attention in current research. The aim of the prospective randomized trial was to review the preliminary results and patients' outcome following treatment with these newly developed implants and to rule out potential differences in fracture treatment of two different plating systems.Twenty patients with distal humeral fractures (AO 13-A1 - AO 13-C3) were included in the current study since 2014. After completing the randomization plan, patients were distributed into two groups for different variable angle locking plates (DePuy Synthes® VA-LCP vs. Medartis® Aptus Elbow). Functional elbow scoring (ROM, MEPS, QuickDASH) served as primary outcome parameter, while radiological fracture consolidation served as secondary outcome parameter. Follow-ups were conducted 6 weeks, 12 weeks, 6 months and 12 months after the operation.Seventeen of 20 patients (85%) concluded all follow-up examinations. Postoperative elbow extension deficiencies showed significant differences between the two groups in all follow-up examinations with a mean of Ø 18 +/- 7.4 degrees in the DePuy Synthes® VA-LCP group compared to a mean of Ø 6.5 +/- 7.5 degrees in the Medartis® Aptus Elbow group (p?=?0.002) 12 months postoperatively. Functional scoring showed a disparate pattern. The Medartis® Aptus Elbow group achieved significantly better MEP scores during follow-up. However, the analysis of the QuickDash revealed better results of the DePuy Synthes® VA-LCP group in the first half and better results of the Medartis® Aptus Elbow group in the second half of the follow-up examination instead.Considering the complexity of distal humeral fractures, the usage of anatomically preshaped low profile variable angle locking plates for operative treatment leads to good clinical results. Even though there might be some advances of the Medartis® Aptus Elbow plating system concerning postoperative ROM and elbow function, a consistent difference in the overall clinical outcome between the two plating systems could not be detected.https://clinicaltrials.gov/ct2/show/NCT03272490 Retrospectively Registered 1. September 2017.

Project description:BackgroundHumeral head inferior subluxation often occurs immediately after osteosynthesis for proximal humeral fracture; however, the underlying cause remains largely unknown. In addition, the prognosis of postoperative inferior subluxation has not been fully investigated. This study aimed to clarify the predictive factors that affected the onset of postoperative inferior subluxation using multivariate analysis and examine the postoperative course of inferior subluxation and its influence on postoperative outcomes.MethodsWe retrospectively reviewed 212 patients who underwent osteosynthesis for Neer 2- or 3-part proximal humeral fractures. In the multivariate analysis, the dependent variable was set as the inferior subluxation observed 1 week after the surgery. The explanatory variables included age, sex, affected side, body mass index, smoking, local osteoporosis, preoperative axillary nerve injury, time from injury to surgery, fracture dislocation, fracture pattern, preoperative inferior subluxation, surgical procedure, surgical approaches, blood loss, operative time, and postoperative drainage. Baseline variables, which were observed to be significant in the univariate analysis, were included in multivariate models. Furthermore, based on the presence of inferior subluxation at 1 week after the surgery, we divided the patients into two groups: with inferior subluxation (+IS group) and without inferior subluxation (-IS group). We compared the postoperative outcomes (incidence of postoperative complications and range of motion) between these two groups.ResultsOf 212 patients, 64 (30.7%) experienced inferior subluxation at 1 week after the surgery. On multivariate analyses, preoperative inferior subluxation (odds ratio = 4.69; 95% confidence interval = 2.45-9.76; P < .001) and longer operative time (odds ratio = 1.01; 95% confidence interval = 1.00-1.02; P = .049) were the risk factors for postoperative inferior subluxation. In the +IS group, inferior subluxation resolved at 1 year after the surgery in 89.5% of patients. There was no significant difference in the postoperative outcome between the +IS and -IS groups. However, four of six patients with persistent inferior subluxation, more than 6 months after the surgery, experienced complications, such as varus angulation of the humeral head or screw joint perforation.ConclusionsThis study provides new information on the risk factors for and prognosis of postosteosynthesis inferior subluxation in patients with proximal humeral fracture. Longer operative time and presence of preoperative inferior subluxation was associated with an increased risk of postoperative inferior subluxation, although it was temporary in most cases, and had no significant influence on the postoperative outcomes. However, in patients with persistent inferior subluxation of more than 6 months duration, inferior subluxation may be related to postoperative complications.