Gainesville, Fla.-based orthopedic device company Exactech recently initiated a prospective, randomized, multi-center clinical trial to evaluate the safety and effectiveness of a new cartilage repair technology, according to an Exactech news release.
The study plans to examine results from 92 surgeries, the first of which was completed on Dec. 1 at National Taiwan University in Taipei. The study will follow patients for one year who are treated for focal chondral or osteochondral knee lesions. The trial will provide evidence for pre-market approval from the Taiwan Food and Drug Administration.
The technology incorporates a tissue processing system that prepares the patients' own cartilage for delivery on the site of a cartilage defect. The single-stage procedure is designed to increase the potential for cartilage regeneration using both mechanical and chemical processing.
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The technology incorporates a tissue processing system that prepares the patients' own cartilage for delivery on the site of a cartilage defect. The single-stage procedure is designed to increase the potential for cartilage regeneration using both mechanical and chemical processing.
Related Articles on Orthopedic Devices:
Amp Orthopedics Initiates Knee & Shoulder Device Clinical Trials
K2M Names Don O'Hearn Senior Vice President of Sales in Americas
39 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in November