Aims

Surgeon and patient reluctance to participate are potential significant barriers to conducting placebo-controlled trials of orthopaedic surgery. Understanding the preferences of orthopaedic surgeons and patients regarding the design of randomized placebo-controlled trials (RCT-Ps) of knee procedures can help to identify what RCT-P features will lead to the greatest participation. This information could inform future trial designs and feasibility assessments.

We carried out a prospective, continuous study on 529 patients who underwent primary total knee replacement between January 2006 and December 2007 at a major teaching hospital. The aim was to investigate weight change and the functional and clinical outcome in non-obese and obese groups at 12 months post-operatively. The patients were grouped according to their pre-operative body mass index (BMI) as follows: non-obese (BMI < 30 kg/m²), obese (BMI ³ 30 to 39 kg/m²) and morbidly obese (BMI > 40 kg/m²). The clinical outcome data were available for all patients and functional outcome data for 521 (98.5%). Overall, 318 (60.1%) of the patients were obese or morbidly obese.

At 12 months, a clinically significant weight loss of ≥ 5% had occurred in 40 (12.6%) of the obese patients, but 107 (21%) gained weight. The change in the International Knee Society score was less in obese and morbidly obese compared with non-obese patients (p = 0.016). Adverse events occurred in 30 (14.2%) of the non-obese, 59 (22.6%) of the obese and 20 (35.1%) of the morbidly obese patients (p = 0.001).