Focal cartilage defects in the knee - a randomized controlled trial comparing autologous chondrocyte implantation with arthroscopic debridement.

BACKGROUND: Focal cartilage injuries in the knee might have devastating effect due to the predisposition of early onset osteoarthritis. Various surgical treatment options are available, however no statistically significant differences have been found between the different surgical treatments. This supports the suggestion that the improvement might be a result of the post-operative rehabilitation rather than the surgery itself. Autologous chondrocyte implantation (ACI) has become a recognized treatment option for larger cartilage lesions in the knee. Although ACI has been compared to other surgical treatment such as microfracture and mosaicplasty, it has never been directly compared to simple arthroscopic debridement and rehabilitation alone. In this study we want to increase clinical and economic knowledge about autologous chondrocyte implantation compared to arthroscopic debridement and physical rehabilitation in the short and long run. METHODS/DESIGN: We will conduct a randomized controlled trial to compare ACI with simple arthroscopic debridement (AD) and physiotherapy for the treatment of cartilage lesions in the knee. The study will include a total of 82 patients, both men and non-pregnant women, with a full thickness cartilage defect in the weight bearing area of the femoral condyles or trochlea larger than 2 cm2. The lesion must be symptomatic, with a Lysholm score less than 75. The two treatment groups will receive identical rehabilitation protocol according to a modification of Wondrasch et al., which is an active rehabilitation and education program divided into 3 phases: accommodation, rehabilitation and return to activity. The patients will be followed for 24 months, with additional late follow-ups at 5 and 10 years to monitor the potential onset of osteoarthtitis. The primary outcome measure will be the difference in the KOOS knee-related quality of life (QoL) subscore in the ACI group compared to the AD group at 2 years. A combination of self-explanatory questionnaires, clinical parameters, clinical hop tests and radiographs and Magnetic Resonance Imaging (MRI) will be used as secondary endpoints. DISCUSSION: This is the first study with a high level of evidence to compare ACI with simple debridement and physiotherapy for the treatment of isolated symptomatic full thickness lesions of the knee. TRIAL REGISTRATION: ClinicalTrial NCT02636881 (21 December 2015).

Norwegican Cartilage Project - a study protocol for a double-blinded randomized controlled trial comparing arthroscopic microfracture with arthroscopic debridement in focal cartilage defects in the knee.

BACKGROUND: Focal lesions to the articular cartilage in the knee might have demolishing consequences to the knee. There exists a wide range of possible surgical procedures targeting these injuries, however no significant differences have been found between these procedures. This may support that the improvement is a result of rehabilitation, and not the surgery itself. Arthroscopic microfracture (MF) treatment has gained popularity, and has become the treatment of choice in patients with knee cartilage defects globally. In this study we want to increase knowledge, both clinical and economic, about arthroscopic microfracture (AF) compared to arthroscopic debridement (AD) and physical rehabilitation both in the short run, and in the long run. METHODS/DESIGN: To compare arthroscopic microfracture with arthroscopic debridement and physiotherapy for the treatment of focal cartilage lesions in the knee, a long-term, double-blinded, randomized controlled multicenter trial will be conducted. A total of 114 men and non-pregnant women with a symptomatic focal full thickness cartilage lesion in the knee less than 2 cm2 will be included in the study. The two treatment allocations will receive identical rehabilitation, which is made up of 3 phases: accommodation, rehabilitation and return to activity. Follow up is 24 months, where all will be invited to participate in late follow ups after 5 and 10 years. The Knee Injury and Osteoarthritis Outcome Score (KOOS) knee-related quality of life (QoL) subscore is the primary endpoint. Clinical parameters, questionnaires and radiologic modalities (Magnetic Resonance Imaging (MRI) and x-ray) will be used as secondary endpoints. DISCUSSION: This is an ongoing multicenter study with a high level of evidence to compare arthroscopic microfracture with arthroscopic debridement and physiotherapy for the treatment of isolated symptomatic full thickness cartilage lesions in the knee joint. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT02637505 (December 15, 2015).

Autologous Chondrocyte Implantation Is Not Better Than Arthroscopic Debridement for the Treatment of Symptomatic Cartilage Lesions of the Knee: Two-Year Results From a Randomized-Controlled Trial.

Purpose: To compare the functional and patient-reported outcome measures after autologous chondrocyte implantation (ACI) and arthroscopic debridement (AD) in symptomatic, isolated cartilage injuries larger than 2 cm2 in patients aged 18 to 50 years. Methods: Twenty-eight patients were included and randomized to ACI (n = 15) or AD (n = 13) and followed for 2 years. The primary outcome was the change in the Knee injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QoL) subscale. Results: The mean age at inclusion was 34.1 (standard deviation [SD] 8.5) years. There were 19 (68%) male patients. The mean size of the lesion was 4.2 (SD 1.7) cm2. There was a statistically significant and clinically meaningful improvement in patient-reported outcome measures from baseline to 2 years in both groups. The improvement from baseline to final follow-up for the primary endpoint (the KOOS QoL subscale) was larger for the AD group (39.8, SD 9.4) compared with the ACI group (23.8, SD 6.7), but this difference was not statistically significant (P = .17). However, according to a mixed linear model there were statistically significantly greater scores in the AD group for several KOOS subscales at several time points, including KOOS QoL, KOOS pain, and KOOS sport and recreation at 2 years. Conclusions: This study indicates that AD followed by supervised physiotherapy is equal to or better than ACI followed by supervised physiotherapy in patients with isolated cartilage lesions of the knee larger than 2 cm2. The improvement in KOOS QoL score from baseline to 2 years was clinically meaningful for both groups (23.8 points for ACI and 39.8 points AD), and larger for the AD group by 16 points. Level of Evidence: Level I, prospective randomized controlled trial.