Spanish Experience in Autologous Chondrocyte Implantation

Abstract

Introduction:The Spanish Ministry of Health commissioned the Galician Agency for Health Technology Assessment to monitor and follow-up Autologous Chondrocyte Implantation (ACI) used to treat chondral lesions of the knee in Spain. The objective of this monitoring was to assess efficacy and safety of the technique.Design:One-hundred and eleven consecutive patients with knee chondral lesions were included in a multi-center study between January 2001 and January 2005. ACI was used in these patients as a second-line treatment option (or a first-line treatment option if the cause was Osteocondritis dissecans). The Cincinnati score and the Short Form 36 (SF-36) questionnaire were used to assess the patients’ self-reported satisfaction with the outcomes of ACI. A descriptive analysis was performed and non-parametric tests were used to establish correlations and compare results among subgroups. A multivariate analysis was also performed to measure the effect of different variables on changes in the condition of the knee.Results:Eighty men (72%) and 31 women (21%) with an age range from 16 to 49 years, underwent ACI surgery. Among these subjects, the most common previous first-line treatment was debridement (64 individuals, 74.4%). The mean size of the lesion treated with ACI was 3.82 cm2, and the most frequent location of the lesion was the inner femoral condyle (53.6%). The patient satisfaction was high or very high in 36 subjects (66.7%). Overall knee joint assessment improved from 4.32 points to 6.78. All SF-36 questionnaire categories improved, notably those related to physical condition.Conclusions:The results of this study indicate that ACI is safe; however, further studies are mandated to assess the efficacy of ACI compared to alternative treatment options.

Early health economic modelling of single-stage cartilage repair. Guiding implementation of technologies in regenerative medicine

“…The SF‐6D is a preference‐based health utility index, ranging from 0 (death) to 1 (perfect health), which was used for the purpose of this economic evaluation. As no pre‐surgery SF‐36 scores were obtained during the trial, the average baseline SF‐36 scores were derived from studies presenting pre‐surgery SF‐36 scores of patients with cartilage defects (Bartlett et al, ; Perez‐Cachafeiro et al, ; Ebert et al, ; Schneider et al, ; Ebert et al, ). The difference in utility between SF‐6D scores at baseline and at 5‐year follow‐up were calculated to determine the clinical effectiveness of both ACI and microfracture.…”

“…To account for possible differences in utility gain, a sensitivity analysis using a 10% range was applied in the model. This range was based on the variation in utility gain after surgical cartilage interventions described in previous reports (Bartlett et al, ; Perez‐Cachafeiro et al, ; Ebert et al, ; Schneider et al, ; Ebert et al, ). For the overall model, QALYs were calculated using the change in utilities over the 5‐year window.…”