This study presents a long-term follow-up on the use of the TruFit™ synthetic scaffold plug for treating focal chondral lesions within the knee. Published in Knee Surgery, Sports Traumatology, Arthroscopy, the research provides valuable insights into the durability of this particular treatment and its ability to repair damaged cartilage over an extended period.
Investigating Long-Term Efficacy
Chondral lesions, or damage to the articular cartilage, are a common cause of pain and limited function in the knee. Because cartilage has limited natural healing ability, there has been significant interest in using scaffolds to facilitate repair. The TruFit™ plug, a synthetic biphasic polymer scaffold, was designed to provide a structural template for new tissue to grow into.
This research followed 11 patients who received the implant, with six patients available for a final follow-up at an average of 121 months (over 10 years). The purpose of this long-term study was to determine if the scaffold provided lasting benefits, both in terms of patient-reported symptoms and visible healing on radiological scans.
Long-Term Outcomes: Clinical and Radiological Findings
While clinical scores for pain and function showed some improvement at the long-term follow-up, the changes were not statistically significant. This indicates that the improvement experienced by patients could not be definitively attributed to the treatment itself.
The radiological findings were more definitive. Imaging revealed:
- Incomplete Incorporation: There was incomplete or no evidence of the scaffold plug being fully integrated into the surrounding bone and cartilage.
- Persistent Cartilage Loss: Scans continued to show persistent defects and cartilage loss at the site of the original lesion, with some patients also displaying signs of bone oedema or cystic changes.
Based on these findings, the authors concluded that the TruFit™ plug did not achieve its intended goal of creating durable, long-lasting repair tissue. The study highlights the need for continued research into scaffold materials and design to ensure they can fully integrate with the native tissue and provide a stable, long-term solution for knee cartilage repair.
On the back of this important study, the Trufit plug was withdrawn from the market and taken off as an option.
To delve into the complete findings, methodology, and analysis, the full research paper is available for your review:
Sources used in report overview:
- https://pubmed.ncbi.nlm.nih.gov/32021049/
- https://pmc.ncbi.nlm.nih.gov/articles/PMC8524698/
- https://www.oatext.com/regeneration-of-articular-cartilage-scaffold-used-in-orthopedic-surgery-a-short-handbook-of-available-products-for-regenerative-joints-surgery.php
