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Long-term Outcomes of Carticel® Studies Presented
May 01, 2002 |
For four days in February, some of the top Orthopedic Surgeons in the country gathered in Dallas, Texas to present and discuss new research and technologies to further advance the treatment and recovery of orthopedic injuries and conditions. Among the studies presented at the American Academy of Orthopedic Surgeons (AAOS), were three studies on Carticel® - the Autologous cultured chondrocytes product marketed by Genzyme Biosurgery. Carticel® uses special process to grow a patient's own (autologous) cartilage cells (chondrocytes) to repair certain types of knee injuries.
The three studies announced at the AAOS convention focused on:
- The five-year results of the first 100 patients treated with Carticel® to repair damaged cartilage on the thigh-bone part of the knee
- The potential of Carticel® in treating injuries to the trochlea
- The results of Carticel® compared with so-called marrow stimulation techniques, an alternative treatment for some cartilage injuries
Five-year Outcomes Study
Presented by: Dr. Jon E. Browne, Clinical Associate Professor, University of Missouri at
Kansas City
Data Source: Cartilage Registry data* to trace the success of the first 100 patients who received Carticel® to repair focal chondral lesions of the femur. Eighty-nine of these patients participated in a full five-year follow up.
According to the study, 79% of patients with available follow-up data say they had an improvement from experiencing pain during activities of daily living to being able to participate in sports with only minor limitations. Thirteen of the first 100 patients fell into the category of treatment failure. This means they had to undergo either another operation to remove the graft or to re-implant it, or a procedure that violates the subchondral bone to treat the defect. In more than half of these 13 patients, their surgeons say the patient had an identifiable reason that may have caused the Carticel® procedure to fail, such as gross non-compliance with the postoperative rehabilitation protocol, an uncorrected mal-alignment, or evidence of generalized
osteoarthritis.
Full-Thickness Articular Cartilage Defects of the Trochlea
Presented by: Dr. Bert Mandelbaum of the Santa Monica Orthopedic and Sports Medicine Group Research Foundation in California
This study looked at the use of Carticel® to repair cartilage injuries to the trochlea, beneath the kneecap. Researchers followed 42 patients over four years following the procedure. They discovered that 73% of patients went from experiencing significant pain from activities of daily living before surgery to being able to participate in sports with only
limited pain afterwards. Six of the 42 patients fell into the category of treatment failure ion of treatment failure, meaning they had to undergo either another operation to remove the graft or to re-implant it, or a procedure that violates the subchondral bone to treat the defect. More than 80% of patients in this study had failed at least one previous cartilage repair operation.
Carticel® versus Marrow Stimulation Techniques
Presented by: Dr. Allen F. Anderson of the Tennessee Orthopaedic Alliance/Lipscomb Clinic
in Nashville.
This study compared the success of Carticel® with that of so-called marrow stimulation techniques, such as abrasion arthroplasty, microfracture and drilling. These alternative techniques are used to treat cartilage injuries to the femur involve penetrating the subchondral bone to form a blood clot, which may in turn form fibrous repair tissue.
At baseline, both groups were similar in age, gender, and lesion size. The Carticel® group, however, had lower baseline scores, a higher percentage of patients on worker's compensation, and more prior injuries. Both groups saw improvement according to the Cincinnati Score*, but the Carticel® group's scores improved more and they were more likely to return to high levels of activities, including sports, three years after treatment.
*Data and information used in all three studies came from the Cartilage Repair Registry, which tracks the progress of patients treated with Carticel®. Data reported in the registry are observational in nature, and represent a multicenter, international experience with the product. The registry is not a controlled clinical study, and patient participation is voluntary. The registry contains functional data using a modified Cincinnati knee scoring system - a rating scale that is widely recognized by orthopaedic surgeons. It does not contain arthroscopic or histologic data. Genzyme Biosurgery is conducting a controlled clinical study of Carticel® and will report on patients up to four years after treatment.
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