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Medical Professionals > Clinical Information > About The CARTICEL Registry

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About the CARTICEL^® Registry

The Cartilage Repair Registry is an international, multi-center, prospective, outcomes assessment database. It is a program that longitudinally assesses clinical outcomes in cartilage repair patients, beginning with the first patient implanted with CARTICELin March of 1995. The Registry reflects Genzyme Biosurgery’s commitment to leadership in cartilage repair.

The Registry uses standardized data collection forms to track treatment outcomes in specific cohorts of patients undergoing implantation with CARTICELwho have consented to participate in the registry. Because the Registry is focusing on the long-term outcomes of existing patients, baseline data is not currently being collected from new patients undergoing a biopsy or CARTICEL implantation. The Registry includes data on:

Grade, location, and size of defects

Concomitant procedures

Previous surgeries

Etiology

Modified Cincinnati Knee Rating Score

Long-term follow-up

An Advisory Board of experienced orthopaedic surgeons reviews the data and provides clinical and scientific oversight. The Registry Advisory Board presents data from the registry at scientific meetings and publishes articles based on the data.

The Advisory Board has commented that, “We feel strongly that this comprehensive data collection should become the standard to be utilized for all evaluations of articular cartilage defects. Furthermore, by collecting longer term follow-up data, a clinical pathway for the treatment of articular defects can be further elucidated.”

The Registry provides valuable data to help address surgeons’ clinical concerns regarding appropriate treatments and prognostic information for articular cartilage injuries. This data is adding to the orthopaedic community’s knowledge about cartilage injury and can help improve clinical decision-making.

Access to the information contained in the Registry is limited to those physicians who participate in the Registry.

Cartilage Repair Registry Advisory Board

Allen F. Anderson, M.D.

Director, Sports Medicine Fellowship
The Lipscomb Clinic
Nashville, TN

Jon E. Browne, M.D.

Program Director of the Orthopaedic Sports Medicine & Knee Fellowship, University of Missouri
Kansas City, MO
Clinical Associate Professor of the Department of Orthopaedic Surgery, University of Kansas
Kansas City, KS

Christoph Erggelet, M.D., Ph.D.

Department of Orthopedics, University of Freiburg
Freiburg, Germany

Freddie H. Fu, M.D.

Chairman, Department of Orthopaedic Surgery, University of Pittsburgh
Pittsburgh, PA

Bert R. Mandelbaum, M.D.

Santa Monica Orthopaedic and Sports Medicine Group
Director of Fellowship at Santa Monica Orthopaedic and Sports Medicine Group
Santa Monica, CA

Lyle J. Micheli, M.D.

Director of Division of Sports Medicine, Children's Hospital - Boston
Associate Clinical Professor, Harvard Medical School
Boston, MA

J. Bruce Moseley, M.D.

The Methodist Center for Sports Medicine
Houston, TX

CARTICEL is for autologous use and is indicated for the repair of symptomatic, cartilage defects of the femoral condyle (medial, lateral or trochlea), caused by acute or repetitive trauma, in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure (e.g., debridement, microfracture, drilling/abrasion arthroplasty, or osteochondral allograft/autograft). CARTICEL should only be used in conjunction with debridement, placement of a periosteal flap and rehabilitation. The independent contributions of the autologous cultured chondrocytes and other components of the therapy to outcome are unknown. It is not indicated for the treatment of cartilage damage associated with generalized osteoarthritis. It is not recommended for patients whose knee meniscus has been surgically removed unless the patient has undergone surgical reconstruction prior to or concurrent with CARTICEL implantation.

Pre-existing conditions including meniscal tears, joint instability or malalignment of the joint should be corrected prior to or concurrent with CARTICEL implantation. It should not be used in patients with a known history of hypersensitivity to gentamicin, other aminoglycosides or materials of bovine origin. CARTICEL is not routinely tested for transmissible infectious diseases and may transmit disease to the healthcare provider handling CARTICEL. In addition, it should not be used in patients who have previously had cancer in the bones, cartilage, fat or muscle of the treated limb. Use in children, patients over age 65, or in joints other than the knee has not yet been assessed.

The occurrence of subsequent surgical procedures (SSPs), primarily arthroscopy, following CARTICEL implantation is common. In the Study of the Treatment of Articular Repair (STAR), forty-nine percent (49%) of patients underwent an SSP on the treated knee, irrespective of their relationship to CARTICEL, during the 4-year follow up. The most common serious adverse events (³ 5% of patients), derived from STAR, include arthrofibrosis/joint adhesions, graft overgrowth, chondromalacia or chondrosis, cartilage injury, graft complication, meniscal lesion, graft delamination, and osteoarthritis.

For more information on CARTICEL, please see the Package Insert (PDF).

About the CARTICEL® Registry

About the CARTICEL^® Registry