| Popis: |
This study was designed to evaluate the safety of a collagen meniscal implant in humans. Ten patients underwent implantation with the collagen implant designed by the authors and produced by ReGen Biologies, Inc. (Franklin Lakes, NJ). The study was performed as a Federal Drug Administration- (FDA-) approved feasibility study. The first patients entered the study in September 1993. All patients met rigid criteria including significant loss or irreparable injury to the medial meniscal cartilage. The study design included clinical follow-up evaluations with a customized knee evaluation form, bone scan, standard and three-dimensional magnetic resonance imaging (MRI) measurements on implant size and location, and a second-look arthroscopy with a biopsy at 3, 6 or 12 months after implantation. In clinical, gross, radiographic, and histological evaluations of the meniscal replacement, appropriate postoperative courses have been noted with relief of symptoms and early regeneration in those cases evaluated by arthroscopy and biopsy to date. |
