| Frequently Asked Questions | |
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Q:
I recently learned of Genzyme Tissue Repair and the work they are doing with Carticel. Can you tell me about this procedure?
Answered by
Jack Farr M.D.
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A:
Carticel was first commercially available in the United States in 1995, and was approved by the FDA in 1997. The procedure is indicated for symptomatic articular cartilage lesions of near-full-thickness or full-thickness involving the end of the femur: that is, the femoral condyles (medial and lateral) as well as the trochlea (the groove in which the patellar tracks). The lesion should have near-normal articular cartilage surrounding it, and the overall alignment must be normal or correctable to “normal.” The meniscus on the same side as the lesion must be near normal or, if missing, it would be necessary to perform a meniscal transplant at the same time as the Carticel implant. Carticel is not used to treat arthritis. THE PROCEDURE: Typically, a patient has already had a surgery for an articular cartilage problem, but they remain symptomatic for more than three months. At this point, if the patient and surgeon decide that Carticel is the best option, then an arthroscopic biopsy is planned. The arthroscopy (which may be performed under local anesthetic) allows reevaluation of the articular cartilage lesion to see if there has been any progression of the lesion and then to precisely size the lesion (the size determines the number of cells necessary to fill the defect). After that, a small biopsy is taken from the margin of the joint surface. This specimen of live articular cartilage is placed into a culture medium, which keeps the cells healthy during their transport to the Genzyme Corporation cell-culture laboratories. Under a strictly controlled environment the cells are separated from the cartilage. These cells are then multiplied using a cell-culture technique. They are stored in the frozen state and are thawed and have a final culturing process before they are shipped to the operating room on the day of the implantation. Currently, the implantation technique requires an open-knee approach. The first step of the surgery is to trim the defect to a stable rim and clean the base of the bone. The template (pattern) of the defect is made from sterile paper and used to trace out the desired cut for harvesting the periosteal patch. The periosteum is the living tissue on the outside of bones. It can be gently separated from the bone and has the consistency of a wet paper bag. This patch is obtained from the shin-bone just below the knee. The patch is then transferred to the defect and micro-sutured into a patch that forms a water-tight seal. It is further sealed with fibrin (biologic) glue. The cultured chondrocytes are then injected under the patch and a final seal of the patch is performed. For graphic illustrations of the Carticel procedure you may want to visit Genzyme Biosurgery or CartilageRestoration.org, and then discuss your specific problem with your Orthopedic Knee Surgeon.
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Q:
I am 35 years old and very active. I would like to continue my current lifestyle; I am suffering with severe knee pain due to the deterioration of my articular cartilage. The doctor says I am too young for a total knee replacement, are there any other options for me?
Answered by
Jack Farr M.D.
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A:
Why is the articular cartilage deteriorating? The articular cartilage can deteriorate due to trauma, or as a result of arthritis, either degenerative (osteoarthritis), or inflammatory (such as rheumatoid arthritis). At present, the treatments for arthritis include medication, protected exercise, weight optimization, activity modification, and in the end stage: total knee replacement. If a mechanical problem has created an articular cartilage defect which is localized to the femur, you may be a candidate for cartilage restoration. The first step is to identify and treat the mechanical problem: examples include meniscal transplantation or bony realignment. Once the mechanics are restored and the exact extent, position, and size of the articular-cartilage lesion are known, then plans can be made for restoration. A symptomatic lesion of less than two square centimeters may be treated with a variety of techniques from marrow stimulation to plug transfers. In your case, as the alternative is a TKA (total knee arthroplasty), the lesion is probably larger than two square centimeters and thus you may be a candidate for Carticel implantation or osteochondral allografting. Explore these options with your surgeon as only your surgeon knows the specifics of your problem.
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Q:
What are the criteria for a patient interested in Carticel?
Answered by
Jack Farr M.D.
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A:
The FDA approved the Carticel procedure in 1997, and established certain guidelines for implantation. These were modified in 1999. Patients who are eligible for Carticel must have articular cartilage lesions of the femur (the condyles or trochlea) that remain symptomatic after standard surgical treatments have failed. The knee should have (or be) correctable to normal alignment, stable and have a functional meniscus (or able to have a meniscal transplant if needed). In addition, there are general guidelines regarding the size of the lesion and the status of the knee in general. Carticel is not indicated for arthritis. As many of these points are fairly technical, it is best for you to talk with an Orthopedic Surgeon trained and experienced in the application of Carticel.
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Q:
What is a typical recovery after having the Carticel procedure?
Answered by
Jack Farr M.D.
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A:
The Carticel procedure is a biologic process. This process starts with the surgery and must be allowed to follow a course that is unique for the patient and knee. In general, it is necessary to protect the implant from loading for at least six weeks. The patient must remain on crutches for femoral condylar lesions and wear a knee extension brace for trochlear lesions. Early range of motion is begun in a continuous passive motion machine and this too is different for each type of lesion. As you can see, the recovery varies according to the site and extent of the lesion. At six weeks, protected weight bearing is allowed with close monitoring of the joint. If there is pain or an increase in fluid on the joint, then progression to further weight bearing is halted. By six months, most patients report an improvement from the preoperative status and then note further improvement at one year, which corresponds to the biologic maturation process of the articular cartilage matrix the implanted chondrocytes are slowly producing. As is now evident, there is no typical recovery after Carticel. Every patient and every knee are unique. Guidelines are available, but only your Cartilage Restoration surgeon can outline a postoperative course for you.
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Q:
I have undergone chondroplasty and experienced little to no relief, my doctor mentioned Carticel, do you think this would help me resume my daily activities?
Answered by
Jack Farr M.D.
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A:
This is a very good question, but you will need to explore specifics with your surgeon. First, Carticel is a very effective technique when used to treat a specific type of articular cartilage lesion—it is not a remedy for all “failed chondroplasties.” So, the first goal will be to establish the cause of the chondrosis. Is it arthritis, is it an injury, is it from malalignment or is it a result of loss of a meniscus? You will then need to know the site of the chondrosis, and the depth and dimensions of the lesions. Please refer to question
# 3 regarding the criteria for Carticel. If you meet all the criteria for Carticel, then Carticel has a good track record (see the Carticel Registry at www.Genzyme.com ) for aiding patients in improving their level of activity and decreasing pain.
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Q:
I have been told that I need a total knee replacement can I have Carticel instead?
Answered by
Jack Farr M.D.
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A:
Carticel is not indicated for the treatment of arthritis. However, only you and your surgeon know the context of your conversation. Did your surgeon say you will need a total joint replacement if something is not done? If that is the case, then you may indeed have an isolated articular cartilage defect that is amenable to cartilage restoration techniques—of which Carticel is one option if you meet the Carticel criteria (please see question #3).
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Q:
When are the benefits of Carticel realized?
Answered by
Jack Farr M.D.
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A:
As the Carticel technique is a biologic process initiated at the time of implantation, the time course and benefits are dictated by biology. This is highly variable from one patient to another and from one knee to another (dependent on the specifics of the lesion and treatment). In general, by reviewing the Carticel Registry of data for more than four years and the Swedish data of over ten years, it is possible to suggest that patients continue to improve from six months to one year and then either maintain that result or note further mild improvement at two years. After two years the results appear to stabilize. The benefits in successful cases include less fluid on the joint, less pain, and functional improvement. As cartilage problems are unique to an individual, it is important to discuss the expected benefits in each case with the treating Cartilage Restoration surgeon.
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