Innovative Devices Did Not Provide Superior Total Knee Arthroplasty Outcomes in Post-Operative Rehabilitation: Results From a Four-Arm Randomized Clinical Trial.

ABSTRACT

BACKGROUND: Orthopedic surgeons face an increasing array of post-TKA (total knee arthroplasty) rehabilitation interventions that entail innovative equipment and devices, but their relative effectiveness remains unknown. The study compared patient outcomes among primary unilateral TKA patients participating in one of 4 post-TKA rehabilitation interventions-a standard-of-care intervention and 3 more recently developed physical therapy interventions. METHODS: The Knee Arthroplasty Rehabilitation Outcomes Study is a 4-arm randomized clinical trial conducted across 15 outpatient rehabilitation clinics. The trial evaluated 4 alternative interventions: (1) a stationary recumbent bike (control intervention); (2) a body weight-adjustable treadmill; (3) a recumbent bike and use of a patterned electrical neuromuscular stimulation device; and (4) a body weight-adjustable treadmill and a patterned electrical neuromuscular stimulation device. The study's outcome measures were patient walking speed and the Knee injury and Osteoarthritis Outcome Score (KOOS) measured at therapy discharge and at follow-up. RESULTS: The study enrolled 363 TKA patients with 90-92 patients in each of the 4 study arms. Participants were similar across the 4 groups They were about 63 years old, 61% female, 67% white, living at home, overweight (mean body mass index = 31.6), with mostly private insurance (61%) or Medicare (32%). Walking speed was similar at admission and discharge; KOOS scores were similar at admission, discharge, and follow-up across the 4 intervention groups. CONCLUSION: The study found no statistical or clinically meaningful differences across the 4 study arms in walking speed or KOOS outcomes. Clinicians, payers, and policy makers will want to encourage providers and patients to use the least expensive intervention since each provide similar outcomes. TRIAL REGISTRATION NCT02426190; https//clinicaltrials.gov/ct2/show/NCT02426190?term=NCT02426190&cntry=US&rank=1.