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.