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).

We hypothesised that meniscal tears treated with mesenchymal stem cells (MSCs) together with a conventional suturing technique would show improved healing compared with those treated by a conventional suturing technique alone. In a controlled laboratory study 28 adult pigs (56 knees) underwent meniscal procedures after the creation of a radial incision to represent a tear. Group 1 (n = 9) had a radial meniscal tear which was left untreated. In group 2 (n = 19) the incision was repaired with sutures and fibrin glue and in group 3, the experimental group (n = 28), treatment was by MSCs, suturing and fibrin glue.

At eight weeks, macroscopic examination of group 1 showed no healing in any specimens. In group 2 no healing was found in 12 specimens and incomplete healing in seven. The experimental group 3 had 21 specimens with complete healing, five with incomplete healing and two with no healing. Between the experimental group and each of the control groups this difference was significant (p < 0.001).

The histological and macroscopic findings showed that the repair of meniscal tears in the avascular zone was significantly improved with MSCs, but that the mechanical properties of the healed menisci remained reduced.