Step 1: Biopsy and knee assessment
An articular cartilage injury may be found during any arthroscopic knee procedure. Many patients who have other knee injuries, such as ACL or meniscal injuries, have concomitant articular cartilage injuries. Prior to any arthroscopic procedure, it may be beneficial to educate the patient on all cartilage repair options, including CARTICEL.
Prior to recommending CARTICEL, it is vital to assess the patient’s candidacy for treatment. Joint condition, concomitant pathologies, size, and number and extent of defects are critical factors in this consideration. These determinations are primarily conducted through standard arthroscopy.
Joint Assessment
- Carefully inspect articular cartilage, tibial plateau, femoral condyle, patella and trochlear groove.
- Assess the patella-femoral joint for abnormal facet tracking and joint surface contact.
Defect Assessment
- Remove all damaged and unhealthy articular cartilage surrounding the defect as well as loose bodies in the joint.
- Ensure defect is surrounded by healthy, stable cartilage, measuring at least 2 to 3 mm thick to accommodate suture fixation of a periosteal patch. If the cartilage is not stable, bone anchors should be considered for final implantation.
- Determine the complete extent and size of the defect to assure that the appropriate number of cell vials is provided at the time of implantation (1 vial for each defect measuring <7cm2; 2 vials measuring 7-14cm2; 3 vials for defects >14cm2).
Contact Carticel
For reimbursement questions, contact a Carticel Care® Coordinator at 800-453-6948, Option #2.
For all other questions, contact a Genzyme Biosurgery representative at 800-453-6948, Option #1.
Important Safety Information
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 (≥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).