CARTICEL: Introduction to CARTICEL Workshop

Introduction to CARTICEL^® Workshop

This program is designed to train and inform orthopaedic surgeons in the clinical utilization of CARTICEL for the repair of articular cartilage injuries in the knee.
Topics for presentation include:

Articular cartilage structure and function

Appropriate candidate selection

Surgical implantation technique

Post-operative patient management and rehabilitation

A bio-skills workshop and case study review supplements the program’s activities.

We strongly recommend each attendee be prepared with at least one case history of a potential CARTICEL candidate to assist in framing the surgeon’s practical development through discussion with program faculty and other participants. Documentation may include, but is not limited to, relevant imaging and arthroscopic photos.

At this time, we regret that we can offer training only to U.S.-based physicians.

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).

Introduction to CARTICEL® Workshop

Introduction to CARTICEL^® Workshop