Subsequent Surgical Procedures
Review of the data from the Study of the Treatment of Articular Repair (STAR) and the Registry Based Study (RBS) [see Clinical Trials Experience] as well as the Carticel worldwide experience (adverse reactions solicited through the Cartilage Repair Registry (CRR) and spontaneous reports) as of November 21, 1997 showed that the occurrence of a subsequent surgical procedure, primarily arthroscopic, following Carticel implantation is common. In the STAR study, 49% of patients underwent a subsequent surgical procedure, irrespective of relationship to Carticel (6.2). Symptoms leading to arthroscopic intervention included catching, locking, clicking or pain. Patients who develop clinical signs of tissue hypertrophy, including catching or clicking, should be evaluated and arthroscopy may be indicated for treatment or further assessment.
Risk Of Transmissible Infectious Diseases
The Carticel product is intended solely for autologous use. Patients undergoing the surgical procedures associated with Carticel are not routinely tested for transmissible infectious diseases. Therefore, the cartilage biopsy and the Carticel product may carry the risk of transmitting infectious diseases to the health care provider handling these tissues. Accordingly, health care providers should employ universal precautions in handling the biopsy samples and the Carticel product.
Pre-surgical Assessment Of Comorbidities
The following conditions should be assessed and treated prior to or concurrent with implantation with Carticel:
- Unstable meniscus tears should be repaired or resected.
- If the patient has had a total meniscectomy, absent meniscus should be reconstructed.
- Instability of the knee may adversely affect the success of the procedure and should be corrected. The anterior and posterior cruciate ligaments should be free of laxity as well as stable and intact. It is recommended that cruciate deficiencies be corrected.
- Abnormal weight-distribution within the joint may adversely affect the success of the procedure and should be corrected. The tibial/femoral joint should be properly aligned. When treating trochlear defects, abnormal patellar mechanics should be assessed and corrected.
Product Safety And Sterility
The safety of the Carticel product is unknown in patients with malignancy in the area of cartilage biopsy or implant. The potential exists for in vitro expansion and subsequent implantation of malignant or dysplastic cells present in biopsy tissue. In addition, implantation of normal autologous chondrocytes could theoretically stimulate growth of malignant cells in the area of the implant, although there have been no reported incidents in humans or animals.
The Carticel product is shipped following a preliminary sterility test with a 48-hour incubation to determine absence of microbial growth. Final (14 day incubation) sterility test results are not available at the time of implantation.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
No carcinogenicity or mutagenicity data are available for Carticel in animals or in humans. No studies on the effects of Carticel on fertility have been conducted.
Use In Specific Populations
Safety and effectiveness in pediatric patients have not been established.
Clinical studies of Carticel did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/27/2016
Additional Carticel Information
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