

The answer is quite lengthy, so please read carefully.
The company that is involved with the "autologous cultured chondrocyte implantation" procedure is Genzyme Corporation. Their product is called "Carticel TM". I will refer to "autologous cultured chondrocyte implantation" as cartilage transplant surgery. I believe that this term will be better understood by the lay person.
In a letter to me from the Genzyme Corporation, I have been notified of the following;
"On August 22, 1997 the FDA granted marketing clearance to "Carticel TM" (autologous cultured chondrocytes) for the repair of clinically significant, symptomatic cartilaginous defects of the femoral condyle (medial, lateral or trochlear) caused by acute or repetitive trauma."
GENZYME CORPORATION is encouraged by the data analysis of 191 patients at the six month follow-up and 84 patients at the 12 month follow-up timepoints. In a periodic report dated June 1997, they state that the surgery is safe and when comparing the aggregate 12 month post operative data to baseline, both clinicians and patients rated the patient's overall condition as significantly improved.
The cartilage transplant surgery may prove to be a good procedure and is to be tried after other treatments have failed. The treatments to be tried first can be arthroscopic debridement and or arthroscopic abrasion surgery.
If the above arthroscopic surgeries fail, then the cartilage transplant surgery can be performed in a knee that has clinically significant, symptomatic cartilaginous defects of the femoral condyle (medial or lateral) caused by acute or repetitive trauma. In other words, an area on the end of the thigh bone (femur) that has lost its cartilage covering (like the white stuff at the end of a chicken bone), and when this area is seen through an arthroscope, bone is visible. This area, after cleansing, is for the cartilage cells to attach to and heal and grow, and hopefully last for many years as healthy cartilage. The cartilage on the shin bone (tibia) directly opposite the bad area on the thigh bone should have at least 50% of its cartilage thickness remaining.
The surgery requires two procedures. The first is arthroscopy, during which, a piece of healthy cartilage is removed from the end of the thigh bone. This is taken from a non-weight bearing portion. This piece of cartilage is then sent to Genzyme Corporation in Massachusetts. They process the cartilage in a tissue culture medium and eventually many new cartilage cells are grown. These cells are collected and sent to the surgeon. The surgeon then opens the knee joint (not arthroscopy) of the same patient, takes a piece of periosteum (skin of the bone) from the front side of the shin bone (tibia). This is then sewn over the defect on the thigh bone (femur) to form a closed envelope through which the cartilage cells are injected. The knee joint is then closed and the patient starts the post operative program, part of which is crutch walking without putting any weight on the operated leg for many months. Usually the patient's activities are restricted for at approximately one year.
The surgery is recommended for patients 50 years old and younger. Young athletic patients may be a greater risk, because they want to start participating in sporting activities too quickly following the surgery, and may not comply with the restrictions placed upon them by their doctor.
The information I have, is that the service for the cartilage cell treatment performed by Genzyme Corporation costs approximately $10,000.00. This does not include the costs of the two surgeries and hospitalizations. Additional information that I gathered, is that some insurance companies, have approved coverage for this surgery. What the cost of the surgery to the covered patient will be, is not known to me. Check with your medical plan to get further information.
The preliminary results in the very select and limited group of patients tend to show promise. The studies are approximately one year old and that is much too soon to indicate that this procedure will supplant other types of surgery.
The other procedures that try to replace absent articular cartilage are:
1- Drilling
2- Micro fracture
3- Abrasion
4- Mosaicplasty (taking bone & cartilage from one part of the knee and
putting it into another part of the same knee.)
One study indicates the following; One and five year results were given for each of the mentioned procedures, except cartilage transplant which has only one year data available.
Drilling and microfracture had 19% good results at one year and 9% with excellent results at five years. Abrasion had 13% excellent results at one year and 6% at five years. Results with mosaicplasty were 3% excellent at one year and 5% at five years. The investigator noted that the cartilage transplant results were good at one year but wondered "will this technique withstand the test of time." Many procedures have good to excellent results at the end of one year, but as the follow ups reach five year results did not remain as positive. One prominent orthopedic surgeon stated that he has great hopes and expectations of wanting to do what is best for our patients. He further states that the orthopedic experts advised us (orthopedic surgeons) against widespread use of this new technology pending further scrutiny.
At the present time (1997), The American Academy of Orthopedic Surgery takes the position that the cartilage transplant (also known as ACI) procedure is as yet unproven. There is evidence that it works under some circumstances, and knowledge of their long term benefits is incomplete.
Discussions with the surgeon, in great detail, should be carried out about the cartilage transplant surgery and then the should be able to make an educated decision, with the doctor, about going ahead and having the surgery.
With any type of arthroscopic surgery please be aware of false advertising by physicians who promise or hint at obtaining excellent results.
Ask many questions such as:
Ask to be able to speak to those patients. The doctor will not give you the patients' phone numbers, but volunteer your phone number to be given to them and ask the doctor to have them call you.
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