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Paper #29 Repeat meniscus repair
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ABSTRACTS
22 were complex in nature. Specific techniques were developed for these cases. A mean of 3.63 sutures (or devices) were used (1 – 12). Failure based on clinical grounds is known to have occurred in only 10 patients with 7 of these being rerepaired. Conclusions: Repairing a torn meniscus is beneficial to the patient in the long term. If the meniscus is suitable for repair and a technically good repair is undertaken then healing can be expected in the majority of cases. Even some of the more difficult and complex tears can heal if treated appropriately. Paper #29 Repeat Meniscus Repair. Ilya Voloshin, Rochester, NY, USA, Miguel Schmitz, Klamath Falls, OR, USA, Kenneth E. De Haven, Presenter, University of Rochester Medical Center, Rochester, NY, USA Eighteen consecutive repeat meniscal repairs were performed over an eleven year period, 17 by the senior author (KED) and 1 by another surgeon. At most recent follow-up 14 of 18 patients (13 repeat meniscus repairs and 1 second repeat meniscus repair) had clinically intact menisci. These patients (14 knees) comprised the study group. All were available for follow-up with a mean follow-up after repeat meniscal repair of 7.33 years (range 3.25 to 13.75 years). The average durability of the initial repair was 3.46 years (range, 0.17-14.67 years). Five patients post-operatively sustained a tear of the meniscus at the site of re-repair. Four of these patients underwent partial meniscectomy. Excluding these four patients, the mean Lysholm score for the remaining 14 patients was 82.1(range, 38-100). The mean Tegner score for this group was 5.6(range, 2-8). On IKDC rating, five knees received an overall grade A score (normal), six knees received an overall grade B score (nearly normal), and three knees received an overall grade C score (abnormal). Ten of the 14 knees in the study had follow-up of 5 years or greater after repeat meniscus repair. Weightbearing AP radiographs were obtained with the knee in full extension and in 45o flexion on these 10 knees. The radiographs revealed grade 0 changes(normal) in 5 of the involved knee compartments and grade I changes(sclerosis or mild narrowing measuring 1-2mm) in the remaining five. We note that repeat repair of suitable retorn menisci has a 72% survival rate to date. This appears to be somewhat lower than that associated with primary repair. However, repeat repair in suitable cases provides relief of symptoms and allows return to strenuous levels of function for most patients, while appearing to preserve the biomechanical role of the meniscus.
Paper #30 Collagen Meniscus Implants (CMI): Multicenter Clinical Trial Results And Long Term Follow-up. William G. Rodkey, Presenter, Steadman Hawkins Clinic, Vail, CO, USA, J. Richard Steadman, Vail, CO, USA Purpose: A collagen based material, the Collagen Meniscus Implant (CMI), was developed as a regeneration scaffold for meniscus cartilage and was tested in US feasibility studies then in international multicenter clinical trials. The initial purpose was to assure safety, implantability, and ability of the CMI to support new tissue ingrowth, then to establish clinical efficacy. Methods: The CMI is made of purified type I collagen fibers from bovine Achilles tendons. Proteoglycans, including hyaluronic acid and chondroitin sulfate are added, and the material is aldehyde cross-linked and terminally sterilized with gamma irradiation. The positive results of a Phase II feasibility study of 8 patients led to FDA Investigational Device Exemption (IDE) approval of a large multicenter randomized (CMI versus meniscectomy alone) clinical trial of 288 patients in the United States. These 288 patients were enrolled at 14 sites throughout the US. Additionally, about 100 nonrandomized patients were enrolled at 10 sites in Europe and two sites in Japan. Current indications for use of the CMI include partial medial meniscus loss with intact rim and no Grade IV chondral defects. Patients in the US multicenter trial underwent frequent clinical exams and relook arthroscopy with biopsy at one year post-implantation. Phase II feasibility study patients underwent relook arthroscopy at 6 or 12 months with biopsy and then again 5 to 6 years after implantation. Results: No serious or life-threatening complications have been attributed to the CMI. Patients routinely returned to daily activities by 3 months and most were fully active by 6 months, then continued to improve through at least two years as evidenced by Tegner and Lysholm scores. ELISA testing failed to detect any increase in antibodies to the collagen material. No increased degenerative joint disease was observed, nor was there radiographic evidence of further joint space narrowing. Sequential MRI examinations revealed progressive signal intensity changes indicating ongoing tissue ingrowth, regeneration, and maturation of the new tissue. At relook arthroscopy, gross appearance and shape of the regenerated tissue generally were similar to native meniscus cartilage with solid interface to the host meniscus rim in the majority of patients. Histologically, the collagen implant was progressively invaded and replaced by cells similar to meniscofibrochondrocytes with production of new matrix. No inflammatory cells or histologic
ABSTRACTS
22 were complex in nature. Specific techniques were developed for these cases. A mean of 3.63 sutures (or devices) were used (1 – 12). Failure based on clinical grounds is known to have occurred in only 10 patients with 7 of these being rerepaired. Conclusions: Repairing a torn meniscus is beneficial to the patient in the long term. If the meniscus is suitable for repair and a technically good repair is undertaken then healing can be expected in the majority of cases. Even some of the more difficult and complex tears can heal if treated appropriately. Paper #29 Repeat Meniscus Repair. Ilya Voloshin, Rochester, NY, USA, Miguel Schmitz, Klamath Falls, OR, USA, Kenneth E. De Haven, Presenter, University of Rochester Medical Center, Rochester, NY, USA Eighteen consecutive repeat meniscal repairs were performed over an eleven year period, 17 by the senior author (KED) and 1 by another surgeon. At most recent follow-up 14 of 18 patients (13 repeat meniscus repairs and 1 second repeat meniscus repair) had clinically intact menisci. These patients (14 knees) comprised the study group. All were available for follow-up with a mean follow-up after repeat meniscal repair of 7.33 years (range 3.25 to 13.75 years). The average durability of the initial repair was 3.46 years (range, 0.17-14.67 years). Five patients post-operatively sustained a tear of the meniscus at the site of re-repair. Four of these patients underwent partial meniscectomy. Excluding these four patients, the mean Lysholm score for the remaining 14 patients was 82.1(range, 38-100). The mean Tegner score for this group was 5.6(range, 2-8). On IKDC rating, five knees received an overall grade A score (normal), six knees received an overall grade B score (nearly normal), and three knees received an overall grade C score (abnormal). Ten of the 14 knees in the study had follow-up of 5 years or greater after repeat meniscus repair. Weightbearing AP radiographs were obtained with the knee in full extension and in 45o flexion on these 10 knees. The radiographs revealed grade 0 changes(normal) in 5 of the involved knee compartments and grade I changes(sclerosis or mild narrowing measuring 1-2mm) in the remaining five. We note that repeat repair of suitable retorn menisci has a 72% survival rate to date. This appears to be somewhat lower than that associated with primary repair. However, repeat repair in suitable cases provides relief of symptoms and allows return to strenuous levels of function for most patients, while appearing to preserve the biomechanical role of the meniscus.
Paper #30 Collagen Meniscus Implants (CMI): Multicenter Clinical Trial Results And Long Term Follow-up. William G. Rodkey, Presenter, Steadman Hawkins Clinic, Vail, CO, USA, J. Richard Steadman, Vail, CO, USA Purpose: A collagen based material, the Collagen Meniscus Implant (CMI), was developed as a regeneration scaffold for meniscus cartilage and was tested in US feasibility studies then in international multicenter clinical trials. The initial purpose was to assure safety, implantability, and ability of the CMI to support new tissue ingrowth, then to establish clinical efficacy. Methods: The CMI is made of purified type I collagen fibers from bovine Achilles tendons. Proteoglycans, including hyaluronic acid and chondroitin sulfate are added, and the material is aldehyde cross-linked and terminally sterilized with gamma irradiation. The positive results of a Phase II feasibility study of 8 patients led to FDA Investigational Device Exemption (IDE) approval of a large multicenter randomized (CMI versus meniscectomy alone) clinical trial of 288 patients in the United States. These 288 patients were enrolled at 14 sites throughout the US. Additionally, about 100 nonrandomized patients were enrolled at 10 sites in Europe and two sites in Japan. Current indications for use of the CMI include partial medial meniscus loss with intact rim and no Grade IV chondral defects. Patients in the US multicenter trial underwent frequent clinical exams and relook arthroscopy with biopsy at one year post-implantation. Phase II feasibility study patients underwent relook arthroscopy at 6 or 12 months with biopsy and then again 5 to 6 years after implantation. Results: No serious or life-threatening complications have been attributed to the CMI. Patients routinely returned to daily activities by 3 months and most were fully active by 6 months, then continued to improve through at least two years as evidenced by Tegner and Lysholm scores. ELISA testing failed to detect any increase in antibodies to the collagen material. No increased degenerative joint disease was observed, nor was there radiographic evidence of further joint space narrowing. Sequential MRI examinations revealed progressive signal intensity changes indicating ongoing tissue ingrowth, regeneration, and maturation of the new tissue. At relook arthroscopy, gross appearance and shape of the regenerated tissue generally were similar to native meniscus cartilage with solid interface to the host meniscus rim in the majority of patients. Histologically, the collagen implant was progressively invaded and replaced by cells similar to meniscofibrochondrocytes with production of new matrix. No inflammatory cells or histologic