Cartilage Injury of the Knee: Current Controversies (2021 Annual Meeting)-Cartilage Injury of the Knee: Current Controversies in 2021-Farr

Video Transcription

Video Summary

The video discussed the different options for cartilage treatment and their challenges. The speaker explained that allografts are not FDA approved, but rather FDA allowed, which means that the FDA approves the procurement and processing of the allografts, but not the specific use of them. This has led to companies using a 361 classification to avoid the expensive and time-consuming process of randomized controlled trials. The speaker also mentioned several products that have been canceled or faced challenges due to return on investment concerns. The FDA has recently tightened regulations on 351 and 361 products, and insurance companies typically require multiple independent studies with randomized controlled trials for coverage. The speaker shared their personal approach to evaluating new products, which includes reading preclinical literature, consulting with design surgeons and early adopters, attending podium presentations, and personally collecting patient reported outcomes. The speaker also discussed a case study in which a decellularized allograft had initially positive results but later led to high failure rates. The video ended by suggesting that further discussions and case studies would be more fruitful than going into current treatment options, as there have been few advances in the field. No credits were mentioned.

Asset Caption

Dr. Jack Farr II

Keywords

cartilage treatment

allografts

FDA approval

361 classification

randomized controlled trials