Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objectives of the Cartilage Repair Registry is to report the long term efficacy and safety of cartilage repair procedures in Registry patients.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carticel (autologous cultured chondrocyte) implantation | Biological | Each Carticel vial of autologous cultured chondrocytes contains approximately 12 million cells implanted into the defect and secured with a periosteal flap. |
| Measure | Description | Time Frame |
|---|---|---|
| Physician assessment of effectiveness of autologous chondrocyte implantation | Overall assessment of the patient by the physician based on knee examination and progress of rehabilitation | 6 month post implantation |
| Physician assessment of effectiveness of autologous chondrocyte implantation | Overall assessment of the patient by the physician based on knee examination and progress of rehabilitation | 12 month post implantation |
| Physician assessment of effectiveness of autologous chondrocyte implantation | Overall assessment of the patient by the physician based on knee examination and progress of rehabilitation | 24 month post implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Patient assessment of effectiveness of autologous chondrocyte implantation | Overall assessment of the patient by the patient based on pain, swelling, giving-way, grinding, stiffness, catching and locking and quantity of exercise | 6 month post implantation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Registry of patients with diagnosis of chondral injury.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Genzyme, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Registry contains data from patients whom were implanted by 1123 surgeons in the U.S. and also data captured on patients treated by 154 surgeons in 15 other countries. | Cambridge | Massachusetts | 02142 | United States |
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002357 | Cartilage Diseases |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004343 | Drug Implants |
| ID | Term |
|---|---|
| D003692 | Delayed-Action Preparations |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided