To evaluate a pilot trial of a postdischarge physiotherapy intervention to improve patient function versus usual physiotherapy in patients undergoing total knee arthroplasty aiming to assess: recruitment rate, feasibility and acceptability of the intervention and control, suitability of outcomes, retention and adverse events and to inform sample size calculation for a definitive trial.
Exploratory pilot randomized controlled trial using independent assessment.
Mixed urban and rural, UK.
Patients undergoing primary, elective unilateral knee arthroplasty for osteoarthritis.
Two additional home physiotherapy visits of functional weight-bearing exercises, functional task-specific training versus treatment as usual.
Oxford Knee Score at 12 months.
completion rates, adverse events, Knee Injury and Osteoarthritis Outcome Score, leg extensor power, timed 10-m walk, timed sit-to-stand, resource use diaries. Assessments completed at baseline (pre-operatively), 3, 6 and 12 months.
Of 181 eligible participants 107 (59.1%) were randomized over 13 months, one participant withdrew, no adverse events. Intervention group n = 56 (mean age 67.8), control group n = 51 (mean age 70.8). The difference in mean change of Oxford Knee Scores between groups (intervention--control) at 12 months was 0.2 (95% confidence interval (CI) -3.8, 4.2), P = 0.94. Patient diaries revealed non-trial additional physiotherapy requires improved measurement.
Successful recruitment and retention rates were achieved. The intervention appeared feasible and acceptable but may be suboptimal in intensity given recent research. A sample size of 1271 participants would be required for a fully powered randomized controlled trial using the main outcome. However new outcomes, potentially of greater validity and responsiveness, require consideration.