Defect of Articular Cartilage Clinical Trial
Official title:
A Prospective, Multi-Center, Randomized, Single-Blind, Controlled Study Comparing the Trufit CB (Cartilage Bone) Implant to Microfracture for the Treatment of Patients With Single, Isolated Defects of the Knee
The purpose of this clinical study is to demonstrate the effectiveness and safety of the Trufit CB (Cartilage Bone) implant for the treatment of single, isolated cartilage defects of the knee compared to Microfracture.
Up to 315 subjects, ages 18 years and older with a single, isolated cartilage defect of the knee will be randomized in a 1:1:1 ratio to 1 of 3 treatment groups: - Trufit CB Implant with rehabilitation protocol; - Trufit CB Implant with rehabilitation protocol; - Microfracture with rehabilitation protocol Rehabilitation program may be standard (6 weeks touch weight to full weight bearing) or accelerated (2 weeks touch weight to full weight bearing). ;
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