Diagnosis
Diagnosing a cartilage injury requires developing a complete picture of the injury, as well as the patient’s medical history and lifestyle. There are many diagnostic tools and patient questions that can provide you with the insight that you need; some are recommended here.
Patient History
- How old is the patient?
- How long have they been experiencing pain in their knee?
- What started the pain?
- Does their knee hurt, catch, lock, give way or swell?
- When does their knee hurt (climbing stairs, on level ground, with weight-bearing activity, at rest)?
- Where is the pain (proximal, distal, medial)?
- What surgeries have been performed and when?
- When were they performed?
- What rehabilitation program was prescribed, and was it followed?
- What was the response to the surgery and rehabilitation?
Knee Exam
- What is the patient’s range of motion (ROM)?
- Is there any joint line tenderness?
- What is the stability of the joint?
- What is the patient’s Q-angle, alignment and gait?
Arthroscopic Assessment
- Where is the defect located?
- What is the size of the defect?
- What other co-morbid conditions need to be treated?
- Is there boney involvement?
- Is the defect uncontained?
Patient’s Post-surgical Goals
- Can they take the necessary recuperation time?
- Are they committed to the full rehabilitation period and program?
- What level of activity would they like to achieve?
- Is a return to sports important?
Medical Records
- Most recent surgical notes
- Arthroscopic photos
- Radiographs
- MRI
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).