A placebo-controlled randomised trial to assess the effect of TGF-ß1-expressing chondrocytes in patients with arthritis of the knee.

The aim of this study was to assess the effect of injecting genetically engineered chondrocytes expressing transforming growth factor beta 1 (TGF-ß1) into the knees of patients with osteoarthritis. We assessed the resultant function, pain and quality of life. A total of 54 patients (20 men, 34 women) who had a mean age of 58 years (50 to 66) were blinded and randomised (1:1) to receive a single injection of the active treatment or a placebo. We assessed post-treatment function, pain severity, physical function, quality of life and the incidence of treatment-associated adverse events. Patients were followed at four, 12 and 24 weeks after injection. At final follow-up the treatment group had a significantly greater improvement in the mean International Knee Documentation Committee score than the placebo group (16 points; -18 to 49, vs 8 points; -4 to 37, respectively; p = 0.03). The treatment group also had a significantly improved mean visual analogue score at final follow-up (-25; -85 to 34, vs -11 points; -51 to 25, respectively; p = 0.032). Both cohorts showed an improvement in Western Ontario and McMaster Osteoarthritis Index and Knee Injury and Osteoarthritis Outcome Scores, but these differences were not statistically significant. One patient had an anaphylactic reaction to the preservation medium, but recovered within 24 hours. All other adverse events were localised and resolved without further action. This technique may result in improved clinical outcomes, with the aim of slowing the degenerative process, leading to improvements in pain and function. However, imaging and direct observational studies are needed to verify cartilage regeneration. Nevertheless, this study provided a sufficient basis to proceed to further clinical testing.

The NexGen LPS-flex to the knee prosthesis at a minimum of three years.

We carried out a prospective study to assess the clinical outcome, complications and survival of the NexGen Legacy posterior-stabilised-Flex total knee replacement (TKR) in a consecutive series of 278 knees between May 2003 and February 2005. Mean follow-up for 259 TKRs (98.2%) was 3.8 years (3.0 to 4.8). Annual follow-up showed improvement in the Knee Society scores (paired t-test, p < 0.05). At the last follow-up, the mean maximum flexion was 135 degrees (110 degrees to 150 degrees). Two knees showed radiolucent lines, but revision was not required because the patients were asymptomatic. Revision was required in one case because of infection, but there were no prosthesis-related revisions. There were no other complications. The estimated survival rate at four years with revision for any reason and prosthesis-related problems was 99.6% and 100%, respectively. This relatively large study indicates that the legacy posterior stabilised-Flex design provides excellent short-term outcome but warrants ongoing evaluation to confirm the long-term durability and functioning of the implant.

Comparison between high and low molecular weight hyaluronates in knee osteoarthritis patients: open-label, randomized, multicentre clinical trial.

Efficacy and safety of high and low molecular weight hyaluronates in knee osteoarthritis patients were compared in a randomized, open-label trial. Patients in the high molecular weight hyaluronate group were treated once weekly for 3 weeks and in the low molecular weight group once weekly for 5 weeks. We evaluated weight-bearing pain, degree of flexion, swelling and knee tenderness; frequency and amount of rescue medication; patient and investigator global assessment of pain, and safety over 12 weeks after final injection of study medication. Significant improvements in pain and WOMAC-Likert scores were observed in both groups, but not between groups. Knee joint pain improvement was noted in both groups by patients and investigators during follow-up. Close correlation was observed between patient- and investigator-reported data. There was no significant difference in side-effects between the groups. In conclusion, the efficacy and safety of high and low molecular weight hyaluronate are similar.