Article

OBJECTIVE: 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. DESIGN: Exploratory pilot randomized controlled trial using
independent assessment. SETTING: Mixed urban and rural, UK. PARTICIPANTS:
Patients undergoing primary, elective unilateral knee arthroplasty for
osteoarthritis. INTERVENTION: Two additional home physiotherapy visits of
functional weight-bearing exercises, functional task-specific training versus
treatment as usual.
MAIN OUTCOME: Oxford Knee Score at 12 months. Secondary
outcomes: 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. RESULTS: 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.
CONCLUSIONS: 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.

Langue : ANGLAIS