Podium Presentation Biomaterials and Scaffolds

18.1.2 - Effect of Patient’s Characteristics on Clinical Outcome Comparing Aragonite-Based Scaffold Implant vs Debridement/Microfractures

Presentation Topic
Biomaterials and Scaffolds
Date
14.04.2022
Lecture Time
14:24 - 14:33
Room
Bellevue
Session Type
Free Papers
Speaker
  • E. Kon (Milano, IT)
Authors
  • E. Kon (Milano, IT)
  • A. Fridman (Israel, IL)
  • K. Lawhorn (Virginia, US)
  • W. Nordt (Richmond, US)
  • K. Zaslav (New York, US)
  • J. Patrascu (Timisoara, RO)
  • G. Agar (Tel Aviv, IL)
  • N. Altschuler (Kfar Saba, IL)
Disclosure
Elizaveta Kon, CartiHeal, Consultant; Nir Altschuler, CartiHeal, Employee

Abstract

Purpose

Patient’s specific characteristics may play a role in determining clinical outcome after cartilage regenerative procedures. The objective of this analysis was to reveal if any correlation existed among patient’s characteristics and clinical outcome in the context of a RCT comparing an aragonite-based scaffold to debridement/microfractures for treating joint surface lesions.

Methods and Materials

A large RCT was performed in 26 medical centers, involving 167 subjects who underwent aragonite-based (Agili-C™, CartiHeal Ltd., Israel) scaffold implantation and 84 subjects who underwent arthroscopic debridement/microfractures (control) for the treatment of chondral/osteochondral knee defects. For each treatment group, the influence of age, sex, BMI, previous ligament reconstruction, pre-injury activity level and smoking history were analyzed to detect if a correlation existed in regards to the clinical outcome, up to the final evaluation at 24 months’ follow-up.

Results

Scaffold superiority over debridement/microfractures was confirmed across all sub-groups and covariates analysis. In the scaffold group, comparable clinical benefit was obtained in subjects younger or older than 50yy (p<0.0001). Moreover, the regenerative approach provided satisfactory outcome even in subjects older than 65yy, although their number in the present cohort was small. Differences between scaffold and control groups were much higher in females than in males, suggesting that the former, who usually present poorer prognosis after cartilage surgery, are good candidates for the aragonite-based implant. In the scaffold group, subjects with BMI lower or higher than 30 presented similar KOOS score improvement at 24 months, with better results than control even in obese patients. Previous ligament reconstruction and smoking history did not negatively influence the scaffold group. Considering pre-injury activity level, the comparison revealed particular advantage for the scaffold in non-active subjects.

Conclusion

The aragonite-based scaffold’s superiority over control was confirmed across all subgroups and covariates. Its efficacy was not influenced by sex, age, BMI, previous ligament surgery, smoking history and activity level.

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