Abstract
Research Type:
Level 4 – Case series
Introduction/Purpose:
Osteochondral lesions of the talus often results in pain, swelling, and impaired function. Current surgical treatments, including debridement/microfracture and autologous chondrocyte implantation, have variable success rates. CartiMax® provides a novel single-stage, alternative to promote hyaline cartilage regeneration. CartiMax® is a viable allograft putty, containing cryopreserved viable chondrocytes and extracellular matrix, that creates a biologically active scaffold capable of integrating with native tissue and repairing focal defects in articular cartilage of up to 5 cm. This study aims to evaluate the safety and effectiveness of CartiMax® in treating talar cartilage lesions. The primary objective is to assess improvements in function and pain postoperatively in 10 patients with OLT, hypothesizing that CartiMax® will lead to superior functional outcomes compared to preoperative scores.
Methods:
Ten patients with OLT underwent CartiMax® implantation following IRB-approved prospective study. Patients underwent an ankle arthroscopy with debridement and CartiMax® implantation. Patients were placed in a splint then a Boot and remained non-weight bearing for 6 weeks post-operation. Comprehensive follow-up examinations were performed at 1 week, 3 weeks, 6 weeks, 3 months, 6 months, and 1 year. Outcome measures included level of function, visual analog scale (VAS) pain scores, foot and ankle ability measure (FAAM) scores, and American Orthopaedic Foot & Ankle Society (AOFAS) function scores.
Results:
No adverse events were reported among participants during the follow-up period. Patients experienced decreased pain, improved range of motion, and were able to return to regular activities within an average of three months postoperatively. Outcome measures demonstrated significant improvements in both pain and function over the one-year follow-up period. A paired t-test comparing preoperative and 12-month postoperative outcomes revealed a significant statistical improvement in the mean FAAM scores, with a change of 15.6 points (p=0.0195).
Similarly, AOFAS total scores improved by 10.8 points (p=0.025), and VAS pain scores showed a reduction of 3.2 points (p=0.0121). These findings indicate enhanced mobility and reduced pain, suggesting the procedure was highly effective in improving foot and ankle function over the 12-month period.
Conclusion:
CartiMax® is a promising single-step allograft for OLT treatment, demonstrating significant improvements in pain and function within one year postoperatively. This study highlights CartiMax®'s potential advantages over traditional techniques, offering a minimally invasive, safe and effective solution for cartilage repair. Future studies with larger sample sizes and longer follow-up periods are warranted to further validate these findings and establish long-term efficacy.