Background Although increasingly used, the benefit of surgical treatment of displaced 2-part proximal humerus fractures has not been proven. This trial evaluates the clinical effectiveness of surgery with locking plate compared with non-operative treatment for these fractures. Methods and findings The NITEP group conducted a superiority, assessor-blinded, multicenter randomized trial in 6 hospitals in Finland, Estonia, Sweden, and Denmark. Eighty-eight patients aged 60 years or older with displaced (more than 1 cm or 45 degrees) 2-part surgical or anatomical neck proximal humerus fracture were randomly assigned in a 1:1 ratio to undergo either operative treatment with a locking plate or non-operative treatment. The mean age of patients was 72 years in the non-operative group and 73 years in the operative group, with a female sex distribution of 95% and 87%, respectively. Patients were recruited between February 2011 and April 2016. The primary outcome measure was Disabilities of Arm, Shoulder, and Hand (DASH) score at 2-year follow-up. Secondary outcomes included Constant–Murley score, the visual analogue scale for pain, the quality of life questionnaire 15D, EuroQol Group’s 5-dimension self-reported questionnaire EQ-5D, the Oxford Shoulder Score, and complications. The mean DASH score (0 best, 100 worst) at 2 years was 18.5 points for the operative treatment group and 17.4 points for the non-operative group (mean difference 1.1 [95% CI −7.8 to 9.4], p = 0.81). At 2 years, there were no statistically or clinically significant between-group differences in any of the outcome measures. All 3 complications resulting in secondary surgery occurred in the operative group. The lack of blinding in patient-reported outcome assessment is a limitation of the study. Our assessor physiotherapists were, however, blinded. Conclusions This trial found no significant difference in clinical outcomes at 2 years between surgery and non-operative treatment in patients 60 years of age or older with displaced 2-part fractures of the proximal humerus. These results suggest that the current practice of performing surgery on the majority of displaced proximal 2-part fractures of the humerus in older adults may not be beneficial. Trial registration ClinicalTrials.gov NCT01246167 .
Background: A femoral nerve block relieves pain after total hip arthroplasty, but its use is controversial due to motor paralysis accompanied by an increased risk of fall.Assumedly, the iliopsoas plane block (IPB) targets the hip articular branches of the femoral nerve without motor blockade. However, this has only been indicated in a cadaver study. Therefore, we designed this volunteer study.Methods: Twenty healthy volunteers were randomly allocated to blinded paired active vs. sham IPB (5 mL lidocaine 18 mg/mL with epinephrine vs saline). The primary outcome was reduction of maximal force of knee extension after IPB compared to baseline. Secondary outcomes included reduction of maximal force of hip adduction, and the pattern of injectate spread assessed with magnetic resonance imaging.Results: Mean (confidence interval) change of maximal force of knee extension from baseline to after IPB was −9.7 N (−22, 3.0) (P = .12) (n = 14). The injectate was consistently observed in an anatomically well-defined closed fascial compartment between the intra-and extra-pelvic components of the iliopsoas muscle anterior to the hip joint. Conclusion:We observed no significant reduction of maximal force of knee extension after an IPB. The injectate was contained in a fascial compartment previously shown to contain all sensory branches from the femoral nerve to the hip joint. The clinical consequence of selective anesthesia of all sensory femoral nerve branches from the hip could be a reduced risk of fall compared to a traditional femoral nerve block. Registration of Trial:The trial was prospectively registered in EudraCT (Reference:2018-000089-12, https ://www.clini caltr ialsr egist er.eu/ctr-searc h/searc h?query =2018-000089-12).
Purpose of Review Fractures of the proximal humerus (PHF) and distal radius (DRF) are among the most common upper extremity fractures in the elderly. Recent randomized controlled trials support non-surgical treatment. Evidence behind the best non-surgical treatment strategy has been sparse and raises questions as to when and how to initiate exercises. The purpose of this systematic review and meta-analysis was to assess the benefits and harms of early mobilization versus late mobilization and supervised versus non-supervised exercises therapy after PHF and DRF. Recent Findings 15 published and 5 unpublished trials were included. Early mobilization after PHF resulted in better function with a mean difference (MD) of 4.55 (95% CI 0.00-9.10) on the Constant Shoulder Score. However, the MD was not found to be clinically relevant. No clear evidence showed that early mobilization after PHF had a positive effect on range of motion or pain. Neither did it lead to more complications. Furthermore, no eligible evidence was found supporting early mobilization to be superior to late mobilization after DRF, or that supervised exercise therapy was superior to non-supervised exercise therapy after PHF and DRF. The quality of evidence on all outcomes was found to be low or very low. Summary Early mobilization after PHF may have a beneficial effect on function. Due to the lack of clear evidence, there is an urgent need for future studies to determine the effect of early mobilization and supervised exercise therapy after PHF and DRF.Prospero ID number: CRD42020167656, date of registration 28.04.2020
Background and purpose: Total shoulder arthroplasty (TSA) and shoulder exercises are both effective treatments for reducing pain and improving function in glenohumeral osteoarthritis. However, the effectiveness of TSA has not been compared with non-surgical treatment in a randomized controlled trial. We will examine whether TSA followed bystandard postsurgical rehabilitation is superior to a 12-week exercise program in patients with primary glenohumeral OA who are eligible for unilateral TSA. Patients and methods: In this Nordic multicenter randomized controlled clinical trial, patients with glenohumeral osteoarthritis eligible for TSA will be allocated to either TSA followed by usual care or exercise only. The exercise intervention comprises 12 weeks of exercise with one weekly physiotherapist-supervised session. Based on the sample size calculation, the trial needs to include 102 patients. Duration and outcome: Recruitment was initiated in April 2021 and is expected to be completed by the end of March 2024. Primary outcome is patient-reported quality of life, measured as total WOOS score 12 months after initiation of treatment. The key secondary outcomes include patient-reported pain intensity at rest and during activity; Disabilities of the Arm, Shoulder, and Hand score (DASH);the use of analgesics during the previous week; and adverse events. Trial registration: The trial is approved by the Central Denmark Region Committee on Biomedical Research Ethics (Journal No 1-10-72-29-21) and by the Danish Data Protection Agency (Journal No 1-16-02-199-21). ClinicalTrials.gov Identifier: NCT04845074.
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