Early Active Motion Versus Sling Immobilization After Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial.

PURPOSE: To compare the effect of early mobilization (EM) with standard rehabilitation (SR) over the initial 24 months following arthroscopic rotator cuff (RC) repair. METHODS: A total of 206 patients with full-thickness RC tears undergoing arthroscopic repair were randomized following preoperative assessment of shoulder range of motion (ROM), pain, strength, and health-related quality of life (HRQOL) to either EM (n = 103; self-weaned from sling and performed pain-free active ROM during the first 6 weeks) or SR (n = 103; wore a sling for 6 weeks with no active ROM). Shoulder ROM, pain, and HRQOL were reassessed at 6 weeks and 3, 6, 12, and 24 months postoperatively by a blinded assessor. At 6, 12, and 24 months, strength was reassessed. At 12 months, ultrasound verified RC integrity. Independent t tests assessed 6-week group differences and 2-way repeated measures analysis of variance assessed changes over time between groups. RESULTS: The groups were similar preoperatively (P > .12). The mean age of participants was 55.9 (minimum, 26; maximum, 79) years, and 131 (64%) were men. A total of 171 (83%) patients were followed to 24 months. At 6 weeks postoperatively, EM participants had significantly better forward flexion and abduction (P < .03) than the SR participants; no other group differences were noted. Over 24 months, there were no group differences in ROM after 6 weeks (P > .08), and pain (P > .06), strength (P = .35), or HRQOL (P > .20) at any time. Fifty-two (25%) subjects (30% EM; 33% SR) had a full-thickness tear present at 12-month postoperative ultrasound testing (P > .8). CONCLUSIONS: EM did not show significant clinical benefits, but there was no compromise of postoperative ROM, pain, strength, or HRQOL. Repair integrity was similar at 12 months postoperatively between groups. Consideration should be given to allow pain-free active ROM within the first 6 weeks following arthroscopic RC repair. LEVEL OF EVIDENCE: Level I, high-quality randomized controlled trial.

Is Immobilization Necessary for Early Return to Work Following Distal Biceps Repair Using a Cortical Button Technique?: A Randomized Controlled Trial.

BACKGROUND: Improvements in surgical fixation to repair distal biceps tendon ruptures have not fully translated to earlier postoperative mobilization; it is unknown whether earlier mobilization affords earlier functional return to work. This parallel-arm randomized controlled trial compared the impact of early mobilization versus 6 weeks of postoperative immobilization following distal biceps tendon repair. METHODS: One hundred and one male participants with a distal biceps tendon rupture that was amenable to a primary repair with use of a cortical button were randomized to early mobilization (self-weaning from sling and performance of active range of motion as tolerated during first 6 weeks) (n = 49) or 6 weeks of immobilization (splinting for 6 weeks with no active range of motion) (n = 52). Follow-up assessments were performed by a blinded assessor at 2 and 6 weeks and at 3, 6, and 12 months. At 12 months, distal biceps tendon integrity was verified with ultrasound. The primary outcome was return to work. Secondary outcomes were pain, range of motion, strength, shortened Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH) score, and tendon integrity. Intention-to-treat analysis was performed. A linear mixed model for repeated measures was used to compare pain, range of motion, strength, and QuickDASH between the groups over time; return to work was assessed with use of independent t tests. RESULTS: The groups were similar preoperatively (p ≥ 0.16). The average age (and standard deviation) was 44.7 ± 8.6 years. Eighty-three participants (82%) were followed to 12 months. There were no differences between the groups in terms of return to work (p ≥ 0.83). Participants in the early mobilization group had significantly more passive forearm supination (p = 0.04), with passive forearm pronation (p = 0.06) and active extension and supination (p = 0.09) trending toward significantly greater range of motion in the early mobilization group relative to the immobilization group. Participants in the early mobilization group had significantly better QuickDASH scores over time than those in the immobilization group (p = 0.02). There were no differences between the groups in terms of pain (p ≥ 0.45), active range of motion (p ≥ 0.09), or strength (p ≥ 0.70). Two participants (2.0%, 1 in each group) had full-thickness tears on ultrasound at 12 months (p = 0.61). Compliance was not significantly different between the groups (p = 0.16). CONCLUSIONS: Early motion after distal biceps tendon repair with cortical button fixation is well tolerated and does not appear to be associated with adverse outcomes. No clinically important group differences were seen. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Arthroscopic Versus Mini-open Rotator Cuff Repair: A Randomized Trial and Meta-analysis.

BACKGROUND: Patients with complete rotator cuff tears who fail a course of nonoperative therapy can benefit from surgical repair. PURPOSE: This randomized trial compared mini-open (MO) versus all-arthroscopic (AA) rotator cuff repair. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: Patients with rotator cuff tears were randomized to undergo MO or AA repair at 9 centers by 23 surgeons. The primary outcome (Western Ontario Rotator Cuff Index [WORC]) and secondary outcomes (American Shoulder and Elbow Surgeons [ASES] score, Shoulder Pain and Disability Index [SPADI] pain subscale, 12-Item Short Form Health Survey [SF-12], reported medication use, adverse events), as well as measurements of range of motion and strength, were collected at 1 month before surgery; at 2 and 6 weeks postoperatively; and at 3, 6, 12, 18, and 24 months postoperatively. A blinded radiologist evaluated rotator cuff integrity on magnetic resonance imaging (MRI) at baseline and 1 year. Intention-to-treat analysis of covariance with the preoperative WORC score, age, and tear size as covariates assessed continuous outcomes. Sex differences were assessed. A meta-analysis synthesized the primary outcome between MO and AA repair with previous trials. RESULTS: From 954 patients screened, 411 were ineligible (276 because of recovery with physical therapy), 449 were screened at surgery (175 ineligible), and 274 completed follow-up (138 MO and 136 AA). The AA and MO groups were similar before surgery. WORC scores improved from 40 preoperatively to 89 (AA) and 93 (MO) at 2 years, for an adjusted mean difference of 3.4 (95% CI, -0.4 to 7.2). There were no statistically significant differences between the AA and MO groups at any time point. All secondary patient-reported outcomes were not significantly different between the MO and AA groups, except the 2-year SPADI pain score (8 vs 12, respectively; P = .02). A similar recovery in range of motion and strength occurred in both groups over time. MRI indicated minimal improvement in muscle relative to fat (AA: n = 3; MO: n = 2), with most worsening (AA: n = 25; MO: n = 24) or remaining unchanged (AA: n = 70; MO: n = 70). Opioid use was significantly reduced after surgery (from 21% to 5%). The meta-analysis indicated no significant standardized mean difference between groups in the primary outcome across all pooled studies (standardized mean difference, -0.06 [95% CI, -0.34 to 0.22]). CONCLUSION: Both AA and MO rotator cuff repair provide large clinical benefits, with few adverse events. There is strong evidence of equivalent clinical improvements. TRIAL REGISTRATION: NCT00128076.

The interobserver reliability of classification systems for radial head fractures: the Hotchkiss modification of the Mason classification and the AO classification systems.

BACKGROUND: Radial head fractures are common injuries, and there is little information on the reliability of classification systems for such injuries. The purpose of our study was to report the interobserver reliability of 2 commonly used classification systems: the Hotchkiss modification of the Mason classification and the AO classification systems. METHODS: We compiled the radiographs from a cohort series of 43 patients with radial head fractures, and 5 observers classified the radiographs according to both classification systems. Additionally, we collapsed the systems, with types II and III combined for the Hotchkiss classification and the final digit dropped for the AO classification. We calculated percent agreement, the kappa statistic and the associated 95% confidence intervals (CIs). RESULTS: The mean percent agreement was 72.3% (95% CI 65.8%-78.9%) for the Hotchkiss classification and 37.7% (95% CI 30.5%-44.9%) for the AO classification. The kappa statistic was 0.585 (0.541-0.661) for the Hotchkiss classification and 0.261 (0.240-0.350) for the AO classification. The mean percent agreement was 89.3% (86.6%-92.0%) for the consolidated Hotchkiss classification and 67.4% (54.6%-80.3%) for the consolidated AO classification. The kappa statistic was 0.760 (0.691-0.805) for the consolidated Hotchkiss classification and 0.455 (0.372-0.521) for the consolidated AO classification. CONCLUSION: The interobserver reliability for the Hotchkiss modification of the Mason classification was moderate, and that for the AO classification was fair according to the criteria of Landis and Koch. Collapsing the Hotchkiss classification improved the reliability to substantial, and collapsing the AO system improved reliability to the lower end of moderate.

Functional Outcomes and Health-Related Quality of Life After Surgical Repair of Full-Thickness Rotator Cuff Tears Using a Mini-Open Technique: A Concise 10-Year Follow-up of a Previous Report.

BACKGROUND: Although good short-term and midterm outcomes are reported for mini-open rotator cuff repair, few prospective studies have investigated long-term results. HYPOTHESIS: Function and health-related quality of life (HRQL) outcomes would be maintained 10 years after mini-open rotator cuff repair. STUDY DESIGN: Cohort study; Level of evidence, 2. METHODS: Patients with a confirmed full-thickness rotator cuff tear who underwent mini-open repair between April 1997 and July 2000 were evaluated preoperatively as well as 1 year and 10 years postoperatively for (1) pain, function, and HRQL using the American Shoulder and Elbow Surgeons (ASES) score and Western Ontario Rotator Cuff Index (WORC) score; (2) active shoulder range of motion (ROM) using goniometry; and (3) satisfaction by an independent evaluator. Changes in function, HRQL, and ROM over time were analyzed using repeated-measures analysis of variance. RESULTS: A total of 84 patients were enrolled, of which 61 (73%) were men; the mean (±SD) age was 53.0 ± 9.9 years. At 10 years, 4 (5%) patients were deceased, and 4 (5%) had symptomatic retears. Fifty-nine (74%) patients were evaluated, composed of 43 (73%) men; 26 (44%) were younger than 60 years. Function and HRQL significantly improved over the course of follow-up (P < .001), primarily within the first postoperative year. At 10 years, the mean ASES score was 90.4 ± 19.4, similar to the 1-year score of 91.1 ± 12.0 (P = .83). The mean WORC score at 10 years was 88.7 ± 17.8, with no change from the 1-year score of 88.4 ± 13.6 (P = .93). This relationship did not change after adjusting for age and tear size. Shoulder ROM was also maintained over 10 years. Flexion ROM improved in the first postoperative year, and this improvement was sustained at 10 years after surgery (P ≥ .30). External rotation ROM was slower to improve postoperatively, and significant improvements were seen between 1 and 10 years (P < .01). Fifty-three patients (90%) were satisfied or very satisfied with their results. Tear size, workers' compensation board claimant status, sex, and smoking status did not influence HRQL or shoulder ROM (P > .06). CONCLUSION: Postoperative improvements in function and HRQL after mini-open rotator cuff repair were retained at 10 years.