Physiotherapist-supervised exercises versus unsupervised home-based exercises after nonsurgically treated proximal humerus fracture: a multicenter randomized controlled trial.

BACKGROUND: Proximal humerus fracture (PHF) is a common fragility fracture in older adults and can have a substantial impact on upper limb function. Although most patients with PHF can be treated nonsurgically, it is unknown whether older adults benefit from supervised exercise therapy after PHF. Therefore, the objective of this trial was to investigate whether 10 weeks of physiotherapist-supervised exercises once a week were superior to 10 weeks of unsupervised home-based exercises in older adults with a nonsurgically treated displaced 2-part PHF. METHODS: This was designed as an assessor-blinded, prospective, randomized controlled trial and took place in 3 Nordic countries. In total, 72 patients (≥60 years) with nonsurgically treated displaced 2-part PHF were randomized to either physiotherapist-supervised exercises once a week for 10 weeks, combined with daily home-based exercises, or to 10 weeks of daily unsupervised home-based exercises. The primary outcome measure was the Disability of the Arm, Shoulder, and Hand (DASH) with a primary endpoint at 3 months. Secondary outcomes were DASH (at 12 months), Constant-Murley Score, the 15D-instrument, Visual Analog Scale, General Self-Efficacy Scale, and Pain Catastrophizing Scale, with follow-up visits after 3 and 12 months. Non-union and patient death within 3 months were counted as complications. RESULTS: The mean age of the patients in both groups was 72 years. At 3 months follow-up, the mean DASH score in the supervised group was 25.9 (SD 16.0) compared to 22.4 (SD 18.9) in the unsupervised group. The mean between-group difference (3.5, 95% CI -5.0 to 12.5) was not clinically relevant. None of the secondary outcome measures presented any clinically relevant or statistically significant between-group differences at 3 or 12 months follow-up. One patient in the supervised group and 3 in the unsupervised group were diagnosed with non-union. One patient from each group died before 3 months follow-up. CONCLUSIONS: This trial provides no evidence that supervised exercises are superior to unsupervised home-based exercises in improving functional outcome or health-related quality of life in older patients with a nonsurgically treated 2-part PHF. Further, our results suggest that most older adults with a nonsurgically treated 2-part PHF can perform home-based exercises without the supervision of a physiotherapist.

A cost-effectiveness analysis of reverse total shoulder arthroplasty compared with locking plates in the management of displaced proximal humerus fractures in the elderly: the DelPhi trial.

AIM: To evaluate the cost-effectiveness of surgical treatment with reverse total shoulder arthroplasty (RTSA) compared with open reduction and internal fixation (ORIF) with a locking plate for patients 65-85 years old with a displaced proximal humerus fracture. METHODS: A cost-utility analysis was conducted alongside a multicenter randomized controlled trial, taking a health care perspective. A total of 124 patients with displaced proximal humerus fractures were randomized to treatment with RTSA (n = 64) or ORIF (n = 60) during a 2-year period. The outcome measure was quality-adjusted life years derived from the generic questionnaire 15D in an intention to treat population. The results were expressed as incremental cost-effectiveness ratios, and a probabilistic sensitivity analysis was performed to account for uncertainty in the analysis. RESULTS: At 2 years, 104 patients were eligible for analyses. The mean quality-adjusted life year was 1.24 (95% confidence interval: 1.21-1.28) in the RTSA group and 1.26 (95% confidence interval: 1.22-1.30) in the ORIF group. The mean cost in the RTSA group (€36.755 [€17,654-€55,855]) was higher than that in the ORIF group (€31.953 [€16,226-€47,279]). Using incremental cost-effectiveness ratio, ORIF was the dominant treatment. When using a probabilistic sensitivity analysis with 1000 replications, the plots were centered around origo. This indicates that there is no significant difference in cost or effect. CONCLUSION: In the cost-utility analysis of treatment of displaced proximal humeral fractures, there were no differences between RTSA and ORIF.

Reverse Shoulder Arthroplasty Is Superior to Plate Fixation at 2 Years for Displaced Proximal Humeral Fractures in the Elderly: A Multicenter Randomized Controlled Trial.

BACKGROUND: Almost 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. METHODS: The 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. RESULTS: There 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). CONCLUSIONS: At 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 EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

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.

INTRODUCTION: The proximal humerus fracture (PHF) is one of the most common fractures in the elderly. The majority of PHFs are treated non-operatively, while 15%-33% of patients undergo surgical treatment. Recent randomised controlled trial (RCT) and meta-analyses have shown that there is no difference in outcome between non-operative treatment and locking plate or hemi-arthroplasty. During the past decade, reverse total shoulder arthroplasty (RTSA) has gained popularity in the treatment of PHF, although there is a lack of RCTs comparing RTSA to non-operative treatment. METHODS: This is a prospective, single-blinded, randomised, controlled, multicentre and multinational trial comparing RTSA with non-operative treatment in displaced proximal humeral fractures in patients 65-85 years. The primary outcome in this study is QuickDASH-score measured at 2 years. Secondary outcomes include visual analogue scale for pain, grip strength, Oxford shoulder score, Constant score and the number of reoperations and complications.The hypothesis of the trial is that operative treatment with RTSA produces better outcome after 2 and 5 years measured with QuickDASH. ETHICS AND DISSEMINATION: In this protocol, we describe the design, method and management of the Nordic DeltaCon trial. The ethical approval for the trial has been given by the Regional Committee for Medical and Health Research Ethics, Norway. There have been several examples in orthopaedics of innovations that result in failure after medium-term follow-ups . In order to prevent such failures and to increase our knowledge of RSTA, we feel a large-scale study of the effects of the surgery on the outcome that focuses on the complications and reoperations is warranted. After the trial 2-year follow-up, the results will be disseminated in a major orthopaedic publication. TRIAL REGISTRATION NUMBER: NCT03531463; Pre-Results.