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Cartilage Injury of the Knee (AANA20)
Evaluation of “New” Cartilage Repair Options-Dr. J ...
Evaluation of “New” Cartilage Repair Options-Dr. Jack Farr II, M.D
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Video Transcription
Video Summary
Dr. Jack Farr from Indianapolis reviews current cartilage repair options, emphasizing challenges in FDA approval, particularly the costly, lengthy HCTP-351 pathway requiring randomized controlled trials (RCTs). Many promising products face market withdrawal due to investment concerns and difficult patient enrollment. Alternatives under the HCTP-361 pathway involve minimally manipulated allografts used homologously, which are not FDA-approved but available for physician use without RCTs, though insurance coverage is limited. Dr. Farr discusses specific products like Particulated Juvenile Allograft Cartilage (P-Jack), allograft cartilage discs (Cardiform, Prochondrix), and particulated autografts, noting varying clinical experience but lack of high-level evidence. He stresses the importance of critical evaluation through literature review, surgeon feedback, and personal clinical outcomes before adopting new therapies. Most products lack FDA approval and insurance reimbursement, with MACI being the only FDA-approved, RCT-backed option. Dr. Farr concludes emphasizing cautious use, diligent monitoring, and informed consent when implementing novel cartilage repair treatments.
Keywords
cartilage repair
FDA approval challenges
HCTP-351 pathway
HCTP-361 pathway
allograft cartilage products
clinical evaluation
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