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

Abstract

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.

Figure.. Participant Recruitment Flow

Other reasons to decline to participate included insurance coverage issues, financial concerns (eg, no insurance, high co-payment), time commitment, requiring particular treatment protocols causing compliance concerns, and relocation. Reasons for exclusion from analysis included incomplete or insufficient data and withdrawal from study. PENS indicates patterned electrical neuromuscular stimulation.