Is CARTICEL right for your patient?

CARTICEL is clinically appropriate for patients with articular cartilage damage in the femoral condyle (medial, lateral, trochlea) caused by acute and repetitive trauma and in patients who have failed a previous repair procedure (e.g., debridement, microfracture, drilling/abrasion arthroplasty or osteochondral allograft/autograft).

Frequently, an articular cartilage defect may be identified based on a patient’s symptoms and clinical evaluation, or may be identified during surgical treatment for another procedure such as ACL or meniscal repair. Patient motivation and expectations, including commitment to rehabilitation, should be considered when determining if CARTICEL is the right choice for your patient.

Here are some additional factors to consider:

Patient Factors

  • Has the patient been treated for a prior cartilage repair procedure, such as debridement, microfracture, drilling/abrasion arthroplasty or osteochondral allograft/autograft?
  • Did the patient receive an optimal result from the first procedure? For example, has the patient been able to return to all the activities they desire since a prior treatment for the cartilage defect?
  • Has the patient compromised or altered their daily activities and/or their ability to participate in sports due to pain or other symptoms?
  • What are the patient’s expectations regarding return to function?
  • Is this patient willing to comply with rehabilitation requirements?

Joint Factors

  • Are there any comorbidities?
  •  Joint malalignment, ligament instability/deficiency or meniscal pathology) should be treated prior to or concomitantly with CARTICEL implantation.
  • The joint should be relatively healthy and the defect should be contained or partially contained by healthy surrounding cartilage.
  • Patients with osteoarthritis should not be considered for CARTICEL implantation.

Defect Factors

  • What is the size of the defect? There is no size restriction on lesions treated with CARTICEL. The average lesion size treated with CARTICEL is 4 cm2.
  • Is there bony involvement? CARTICEL has demonstrated efficacy in treating patients with osteochondritis dissecans.
  • Where is the defect located? CARTICEL is approved to treat articular cartilage injuries in the femoral condyle (medial, lateral, trochlea).

 

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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.

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Results of the Study of Treatment for Articular Repair (STAR) Trial

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).