Introduction

Autologous chondrocyte implantation presents a viable alternative to microfracture in the repair of damaged articular cartilage of the knee; however, outcomes for patellar lesions have been less encouraging. ChondroCelect (CC) is an innovative, advanced cell therapy product consisting of autologous cartilage cells expanded ex vivo through a highly controlled and consistent manufacturing process.

Purpose: Long-term follow-up was to determine clinical benefit of ChondroCelect (CC) in the repair of full-thickness femoral cartilage lesions as compared to microfracture (MF).

Methods: In a randomized controlled clinical trial CC (n=57) was compared to MF (n=61) in patients aged 18 to 50 years with single ICRS grade III/IV symptomatic cartilage defects of the femoral condyles. Clinical improvement was measured up to 36 months using the KOOS (Knee injury and Osteoarthritis Outcome Score). Safety was monitored throughout the study.

Results: At baseline, KOOS was comparable between treatment groups (Mean ± SD: CC, 56.30 ± 13.61 and MF, 59.53 ± 14.95). Improvement from baseline in adjusted mean ± SE for the Overall KOOS was 21.25 ± 3.60 for the CC group vs. 15.83 ± 3.48 for the MF group at 36 months. When using the mixed linear model analysis at 36 months, statistically significantly greater improvements were demonstrated in the CC group vs. the MF group in change from baseline for the overall KOOS (D 7.60%, P = 0.018), as well as in 4 of 5 KOOS domains (activities of daily living, pain, symptoms/stiffness, and quality of life). Percentages of treatment responders were 83% (n = 34/41) vs. 62% (n = 31/50) based on the KOOS for CC and MF groups, respectively. Two (3.9%) patients in the CC group and 7 (11.5%) patients in the MF group underwent a re-intervention and were therefore considered treatment failures. Both treatments were well tolerated and the proportion of patients reporting AEs diminished over time, indicating stabilization of the patients’ condition.

Conclusions: Implantation of ChondroCelect in the treatment of articular cartilage defects of the femoral condyles shows superior clinical benefit at 36 months vs. microfracture. Structural superiority in favour of the ChondroCelect group was previously demonstrated at 1 year follow up.

Purpose: A three-year evaluation of long-term clinical efficacy of Characterized Chondrocyte Implantation (CCI) compared to microfracture (MF), in the repair of symptomatic cartilage defects of the femoral condyles at 36 months post-surgery.

Materials and Methods: In a prospective, randomized, controlled, multicenter trial, CCI was compared to MF in patients aged 18–50 years with a single symptomatic ICRS grade III–IV lesion of the knee. Clinical outcome was measured 36 months after surgery by means of the KOOS, VAS for pain and ARS, with a non-inferiority margin preset at 9 % points for KOOS and VAS. Furthermore, response to treatment and progression of knee symptoms were assessed. Treatment failure was monitored throughout the study.

Results: Improvement from baseline was higher in the CCI group (N = 41) compared to the MF group (N = 49) for all clinical outcome parameters. Mean improvement from baseline for Overall KOOS was 22.14 vs. 14.48, respectively, with VAS and ARS scores revealing a similar trend. Responder analysis showed 83% of the patients treated with CCI improving vs. 61% after MF. Additionally, we observed a shift in the proportion of knee symptoms over time (52% vs. 35% of asymptomatic knees at 36 months compared to 2% vs. 8% at baseline in the CCI and MF group respectively). At 36 months, failure rates were low in both groups (n=2 in CCI vs. n=7 in MF).

Conclusions: Previous data have described a superior structural repair after CCI compared to MF at 1 year post-surgery. Continued clinical improvement as well as a favorable responder analysis was demonstrated for CCI compared to MF at 36 months.

Purpose: As a one-step surgical procedure, microfracture is frequently considered to be technically easier and associated with less postoperative morbidity than autologous chondrocyte implantation (ACI), which involves both arthrotomy and arthroscopy and therefore safety was assessed in patients with symptomatic cartilage lesions of the knee treated with characterized chondrocyte implantation (CCI) or microfracture.

Methods: CCI (n=57) was compared to microfracture (n=61) in patients with grade III–IV symptomatic cartilage defects of the femoral condyles in a Phase III, prospective, multi-center, randomized, controlled trial. Safety assessments included adverse events (AEs), physical examination, vital signs, hematology and clinical chemistry.

Results: At 18 months post-surgery, similar proportions of patients experienced AEs in the CCI (88%) and microfracture (82%) groups; 67% and 59%, respectively, experienced AEs considered treatment related. The AE profile was generally similar between groups, with no significant difference for hypertrophy, although significantly more CCI-treated patients had joint swelling (19% versus 4.9%; p=0.022) and treatment-related joint crepitation (12% versus 1.6%; p=0.028). Although the proportion of patients with severe AEs was similar for CCI (12%) and microfracture (13%), slightly more microfracture-treated patients experienced serious (life-threatening or requiring hospitalization) AEs (13% versus 8.8%). No patients discontinued due to AEs or died during the study.

Conclusion: Contrary to general opinion, the two-step CCI procedure, involving arthroscopy followed by arthrotomy, has a similar safety profile to that of microfracture, a one-step arthroscopic procedure, for treating cartilage lesions of the knee.

Purpose: This study compared the efficacy and safety of Characterized Chondrocyte Implantation (CCI) to microfracture in the repair of symptomatic cartilage defects of the femoral condyle.

Methods: CCI (n=51) was compared to microfracture (n=61) in patients with grade III–IV symptomatic cartilage defects of the femoral condyles in a prospective, multicenter, randomized, controlled trial. Structural repair was assessed at 1 year by histopathologists blinded to the treatment using

computerized histomorphometry and

Results: CCI resulted in better structural repair than microfracture at 1 year post-treatment, as assessed by histomorphometry (p=0.003) and overall histology (p=0.012). Structural repair parameters relating to chondrocyte phenotype and tissue structure were also superior with CCI. Noninferiority of CCI was demonstrated for clinical outcome at 12–18 months, and both treatments were generally well tolerated.

Conclusion: At 1 year post-treatment, CCI resulted in superior tissue repair compared to microfracture. Short-term clinical outcome after 12–18 months was similar for both treatments, as was the safety profile. The superior structural repair achieved with CCI may lead to improved long-term clinical benefits.

Aims: We studied the outcome of a progressive correction of the rotation malalignment syndrome with combined supracondylar and proximal tibial osteotomy. We evaluated the associated anterior knee pain in most patients due to patellar maltracking. Methods: Between 1991 and 2002, 56 combined femoral and tibial osteotomies were performed in 37 patients (mean age 18 years). Ilizarov method was used for correction of the idiopathic anteversion with combined tibial external rotation. The þxator was kept in place for an average of 4.4 months and mean follow up was 3 years. Results: In more than 90% of the patients with preoperative anterior knee pain, the symptoms diminished or disappeared. All alignments were corrected adequately. A temporary neuropraxia of the peroneal nerve was seen with acute derotation of the tibia. This technique was abandoned. Four patients were not satisþed for cosmetic reasons, due to the multiple scars from the pins especially on the upper thigh. Postoperative problems were uncommon. There was one undisplaced femoral fracture after removal of the frame and one overcorrection was seen, that could be treated with a new osteotomy with progressive external derotation. Conclusions: The progressive derotation technique using the Ilizarov method allows a reliable correction of a rotational malalignment syndrome with a concomitant improvement of anterior knee pain