Effectiveness of Antigravity Treadmill Therapy After Lower Extremity Periarticular Fracture: A Randomized Clinical Trial.

Abstract

Early, controlled weight-bearing using an antigravity treadmill may improve outcomes following definitive fixation of lower extremity periarticular fractures. We hypothesized that patients randomized to 10 weeks of antigravity treadmill therapy would report better 6-month joint-specific patient-reported function compared with standard of care. This prospective, multicenter, randomized trial included patients 18 to 55 years of age with fractures of the knee and distal tibia randomly assigned to either 10 weeks of antigravity treadmill therapy (intervention) or standard of care (control). The primary outcome was 6-month patient-reported function (Knee injury Osteoarthritis Outcome Score) for patients with knee fractures and Ankle Osteoarthritis Scale for patients with distal tibia fractures. Secondary outcomes included 6-month Patient-Reported Outcomes Measurement Information Systems Physical Function scores, 12-month fracture healing and complications, and 6-week, 3- and 6-month satisfaction with therapy. Of 80 randomized patients, 78 were included in the final analysis (intervention n = 38; control n = 40). Their mean age was 37 years; 55 (71%) had knee fracture and 23 (29%) had distal tibia fracture. The average Knee injury Osteoarthritis Outcome Score were 54 and 61 in the intervention and control groups, respectively (adjusted difference: -6.1; 95% confidence interval, -18.4, 6.2; P = 0.32). The average Ankle Osteoarthritis Scale scores were 28 and 50 for the intervention and control groups, respectively (adjusted difference: -19.5; 95% confidence interval, -39.3, 0.30; P = 0.05). No difference was found between treatment groups in Patient-Reported Outcomes Measurement Information Systems Physical Function, fracture healing, or complications. Patients in the intervention group reported higher satisfaction with their therapy at 6 weeks (9.5 vs. 8.5; P = 0.01) and 3 months (9.5 vs. 8.6; P = 0.04). This study suggests that antigravity treadmill therapy may be beneficial for patients with distal tibia fractures. Moreover, the study demonstrates that a 10-week antigravity treadmill therapy program is safe and feasible with high patient satisfaction, providing foundation for future effectiveness trials for patients with periarticular injuries.