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.

Surgery with locking plate or hemiarthroplasty versus nonoperative treatment of 3-4-part proximal humerus fractures in older patients (NITEP): An open-label randomized trial.

BACKGROUND: Proximal humerus fractures (PHFs) are common fractures, especially in older female patients. These fractures are commonly treated surgically, but the consensus on the best treatment is still lacking. METHODS AND FINDINGS: The primary aim of this multicenter, randomized 3-arm superiority, open-label trial was to assess the results of nonoperative treatment and operative treatment either with locking plate (LP) or hemiarthroplasty (HA) of 3- and 4-part PHF with the primary outcome of Disabilities of the Arm, Shoulder, and Hand (DASH) at 2-year follow-up. Between February 2011 and December 2019, 160 patients 60 years and older with 3- and 4-part PHFs were randomly assigned in 1:1:1 fashion in block size of 10 to undergo nonoperative treatment (control) or operative intervention with LP or HA. In total, 54 patients were assigned to the nonoperative group, 52 to the LP group, and 54 to the HA group. Five patients assigned to the LP group were reassigned to the HA group perioperatively due to high comminution, and all of these patients had 4-part fractures. In the intention-to-treat analysis, there were 42 patients in the nonoperative group, 44 in the LP group, and 37 in the HA group. The outcome assessors were blinded to the study group. The mean DASH score at 2-year follow-up was 30.4 (standard error (SE) 3.25), 31.4 (SE 3.11), and 26.6 (SE 3.23) points for the nonoperative, LP, and HA groups, respectively. At 2 years, the between-group differences were 1.07 points (95% CI [-9.5,11.7]; p = 0.97) between nonoperative and LP, 3.78 points (95% CI [-7.0,14.6]; p = 0.69) between nonoperative and HA, and 4.84 points (95% CI [-5.7,15.4]; p = 0.53) between LP and HA. No significant differences in primary or secondary outcomes were seen in stratified age groups (60 to 70 years and 71 years and over). At 2 years, we found 30 complications (3/52, 5.8% in nonoperative; 22/49, 45% in LP; and 5/49, 10% in HA group, p = 0.0004) and 16 severe pain-related adverse events. There was a revision rate of 22% in the LP group. The limitation of the trial was that the recruitment period was longer than expected due to a high number of exclusions after the assessment of eligibility and a larger exclusion rate than anticipated toward the end of the trial. Therefore, the trial was ended prematurely. CONCLUSIONS: In this study, no benefit was observed between operative treatment with LP or HA and nonoperative treatment in displaced 3- and 4-part PHFs in patients aged 60 years and older. Further, we observed a high rate of complications related to operative treatments. TRIAL REGISTRATION: ClinicalTrials.gov NCT01246167.

The impact of full-thickness rotator cuff tear on shoulder function and quality of life in patients who sustain a proximal humerus fracture-a prospective cohort study.

BACKGROUND: Only few studies have investigated the impact of rotator cuff integrity on patients with proximal humerus fracture (PHF). We aimed to determine if the presence of a rotator cuff tear impairs shoulder function and health-related quality of life (HRQoL) after nonsurgically treated PHF. METHODS: Sixty-seven patients with PHF were recruited prospectively in a cohort. Presence of a full-thickness rotator cuff tear was determined by ultrasound examination. After 6 and 12 months, Constant-Murley Score; Disability of the Arm, Shoulder and Hand; the Visual Analog Scale; EuroQol-5 Domain; and the 15D scores were compared between the patients with a rotator cuff tear and patients with an intact rotator cuff. RESULTS: The prevalence of a full-thickness rotator cuff tear was 34%. After 12 months, the mean Constant-Murley Score was 65.7 (standard deviation 16.3) in the intact rotator cuff group vs. 53.9 (16.0) in the rotator cuff tear group (mean diff. 11.8, 95% confidence interval 2.5; 21.2) and was found to be a clinically relevant difference. A significantly lower HRQoL was found on the EuroQol-5 Domain score after 12 months in the rotator cuff tear group with a median score of 1 (interquartile range 0.23) in the intact rotator cuff group vs. 0.75 (interquartile range 0.34) in the rotator cuff tear group (P = .03). In the remaining outcome measures, no statistically significant between-group differences were detected. CONCLUSION: Rotator cuff tear in older adults with nonsurgically treated PHF may be considered a prognostic factor for poorer shoulder function and HRQoL. This knowledge can support the planning of treatment.

The Benefits and Harms of Early Mobilization and Supervised Exercise Therapy after Non-surgically Treated Proximal Humerus or Distal Radius fracture: A systematic Review and Meta-analysis.

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. 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.

An iliopsoas plane block does not cause motor blockade-A blinded randomized volunteer trial.

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.clinicaltrialsregister.eu/ctr-search/search?query=2018-000089-12).