Effect of Outpatient Rehabilitation on Functional Mobility After Single Total Knee Arthroplasty: A Randomized Clinical Trial.

Importance: Even without evidence, rehabilitation practitioners continue to introduce new interventions to enhance the mobility outcomes for the increasing population with a recent total knee arthroplasty (TKA). Objective: To compare post-TKA functional mobility outcomes among 3 newly developed physical therapy protocols with a standard-of-care post-TKA rehabilitation protocol. Design, Setting, and Participants: This randomized clinical trial included 4 study arms implemented in 15 outpatient clinics within a single health system in the Baltimore, Maryland, and Washington, District of Columbia, region from October 2013 to April 2017. Participants included patients who underwent elective unilateral TKA, were aged 40 years and older, and began outpatient physical therapy within 24 days after TKA. A total of 505 patients were screened and 386 participants were enrolled. Patients provided informed consent and were randomly assigned to 1 of 4 groups. Blinding patients and treating therapists was not feasible owing to the nature of the intervention. Analysis was conducted under the modified intent-to-treat principle from October 2017 to May 2019. Interventions: The control group used a standard recumbent bike for 15 to 20 minutes each session. Interventions used 1 of 3 modalities for 15 to 20 minutes each session: (1) a body weight-adjustable treadmill, (2) a patterned electrical neuromuscular stimulation device, or (3) a combination of the treadmill and electrical neuromuscular stimulation. Main Outcomes and Measures: Outcomes included the Activity Measure for Post-acute Care basic mobility score, a patient-reported outcome measure, and the 6-minute walk test. Outcomes were measured at baseline, monthly, and on discharge from outpatient therapy. Results: Data from 363 patients (mean [SD] age, 63.4 [7.9] years; 222 [61.2%] women) were included in the final analysis, including 92 participants randomized to the control group, 91 participants randomized to the treadmill group, 90 participants randomized to the neuromuscular stimulation device group, and 90 participants randomized to the combination intervention group. Activity Measure for Post-acute Care scores at discharge were similar across groups, ranging from 61.1 to 61.3 (P = .99) with at least 9.0 points improvement (P = .80) since baseline. The distances as measured by the 6-minute walking test were not statistically different across groups (range, 382.9-404.5 m; P = .60). Conclusions and Relevance: This randomized clinical trial found no statistically or clinically significant differences in outcomes across the 4 arms. Because outcomes were similar among arms, clinicians should instead consider relative cost in tailoring TKA rehabilitation. Trial Registration: ClinicalTrials.gov Identifier: NCT02426190.

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

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.