BACKGROUND: Total Knee Replacement (TKR) is the standard treatment for patients with severe knee osteoarthritis (OA). Significant improvement in pain and function are seen after TKR and approximately 80% of patients are very satisfied with the outcome. Functional status prior to TKR is a major predictor of outcome after the intervention. Thus, improving functional status prior to surgery through exercise may improve after surgery outcome. However, results from several previous trials testing the concept have been inconclusive after surgery.
METHODS/DESIGN: In a randomized controlled trial (RCT) we will test the effect of a pre-operative neuromuscular training program versus an attention control program on lower extremity function - before and after surgery. We will enroll 80 participants, aged between 55-90 years, who are scheduled for TKR. In this single-blinded RCT, the intervention group will receive a minimum of 8 and a maximum of 24 training sessions plus 3 educational sessions of the knee school. The control group will receive the 3 educational sessions only. Assessments are performed immediately before and after the intervention (before surgery), at 6 weeks, 3 months and 12 months (after surgery). The primary outcome will include the Chair Stand Test as a measure of leg strength and reaction time. Secondary outcomes are knee function and pain assessed with the self-reported Knee Injury and Osteoarthritis Outcome Score (KOOS). All measurements will be carried out by a specially trained physical therapist, blinded to group allocation.
DISCUSSION: To our knowledge this is the first single-blinded RCT to test the effect of pre-operative neuromuscular training plus knee school against knee school alone--on knee function and pain, assessed immediately after the interventions prior to surgery and repeatedly after surgery.
TRIAL REGISTRATION: Clinical Trials NCT00913575.