Dr. Brian Cole: Comprehensive Approach to Cartilage RestorationBy Katy Gladysheva, Knee1/Body1 Staff
Imagine if there existed a place where patients with all types of cartilage conditions could come for comprehensive evaluation, consultation, care and follow-up. And if such a facility could bring together and build upon the most up-do-date research in the fields of articular cartilage and meniscus restoration. And if there was a team of professionals trained to address everything from the traditional to recent breakthrough techniques in cartilage restoration, giving hope to thousands of patients who only ten years ago faced total knee replacement as their only option?
In Illinois, those dreams became a reality more than a year ago with the creation of the Rush Cartilage Restoration Center at Rush-Presbyterian St.-Luke’s Medical Center in Chicago. Its medical director, Dr. Brian Cole, is one of the few orthopedic surgeons performing autologous chondrocyte implantation procedures at Rush. He is also the primary investigator for a longitudinal study comparing this technique with others. Dr. Cole’s long-standing interest in innovative techniques in cartilage restoration was already apparent early in his residency training. Prior to entering the residency program at the Hospital for Special Surgery in New York, he received an MD and an MBA from the University of Chicago. Following his residency, Dr. Cole completed a sports medicine fellowship at the University of Pittsburgh. Dr. Cole’s efforts at Rush bring a scientific approach to the evaluation and implementation of new technologies aimed at restoring articular cartilage.
Knee1: How did you first become interested in cartilage restoration?
Dr. Cole: As a resident at the Hospital for Special Surgery, the problem most difficult to manage were patients who were relatively young and active and had knee pain that was due to either problems in the articular cartilage (cartilage that lines the ends of bones), or problems with their meniscus. Essentially at that time – in the early 1990s – there were no good solutions to manage these conditions rather than palliative care, which often included modifying their activity level, taking anti-inflamatories, and sometimes arthroscopic surgery. During my training, there was an evolution in the treatment for patients who were considered too young for knee replacement and were facing knee problems during the prime of their lives. The downside of selecting knee replacement surgery for younger patients is the risk they run of wearing the replacement out early and needing it redone later on. The results for a revision knee replacement are not nearly as good as for the primary knee replacement, so the expectation is that the longer an individual waits and the less active they are, the longer the artificial joint may last.
Knee1: Currently, the ballpark figure cited for the “lifetime” of knee replacements is 15 years, on average. What was the situation like ten years ago when you were beginning your post-graduate training?
Dr. Cole: It was about the same then as well. When we look at young patients, the knee replacements also last about 15 years. The point is, if you take a patient who is 35-40 years old with disabling knee pain and perform knee replacement surgery, they are only 50 when they come back for revision surgery, and then 60 when the revision is needed again. That is due to the fact that each successive replacement is predicted not to last as long as the initial one.
Knee1: How was the Rush Cartilage Restoration Center developed?
Dr. Cole: When I started at Rush-Presbyterian -St. Luke's, one of my initiatives and hopes was to develop a program to address the specific problem we were just discussing – that of taking care of patients who were relatively active and otherwise healthy and who were often told that they had no other solution to their problem besides a knee replacement. My goal was to stay on top of the developing research and to attempt to harness all the potential solutions under one roof. With that in mind, we developed Rush Cartilage Restoration Center within Rush-Presbyterian -St. Luke's Medical center a little over a year ago.
The implicit goal is to harness the basic science that has been going on for many years at Rush at a very high level and couple that with the clinicians who are interested in the problems of articular cartilage and meniscus disease. Additionally, such a setting allows us to create a prospective data collection on all of our patients. Frankly, a good prospective comparative study looking at the various procedures has never been undertaken during the evolution of the cartilage restoration process that began in the early 1990s, when various procedures became more popular in the United States. All of our patients who have cartilage problems are entered into a database that uses various outcome scales to measure their function and impairment before any intervention is done, as well as at various follow-up periods. Also as the principal investigator for the collagen meniscal implant study, we are evaluating a synthetic meniscus that allows people who are meniscus-deficient to have a potentially alternative treatment option.
Knee1: Do patients have their surgery performed at Rush Hospital in Chicago?
Dr. Cole: Yes, they get operated on at Rush. We use the procedures that are done at many other institutions, but we are trying to consolidate them under one decision-making process in order to perfect the algorithm as we go along. We are collecting data using the most stringent indications for these procedures, making sure that we at least respect the indications as we currently understand them in the orthopedic community and apply these to select the various procedures for patients with appropriate problems. The types of procedures that we are doing are the arthroscopic washing out of the joint; microfracture, which is a technique that induces fibro-cartilage to form in areas with localized cartilage loss; autologous chondrocyte implantation, often in patients with large defects who have failed primary treatment; osteochondral autograft procedures, where we take plugs of bone and cartilage from relatively non-weight bearing areas of the knee and transplant them to weight-bearing areas of the knee; and finally osteochondral allograft procedures, along with establishing a fresh cartilage program.
There are only a few sites in the country that specialize in fresh cartilage or fresh allografts and we are establishing another site in the Midwest based at Rush. We believe that fresh cartilage may be one of the best solutions for very large defects that are associated with bone loss as well as articular cartilage loss. Currently, there appears to be a meniscus shortage, so we are making efforts to overcome that by using the donors in Illinois who donate their cartilage (the meniscus as well as the articular cartilage) and then re-implanting them primarily in patients from Illinois. Finally, another procedure that we do is meniscus allograft transplantation in patients who have lost their meniscus. The interesting thing is that many of our patients have very complex histories. Many of them have had at least one and often two or more, surgeries before they've come to us.
Knee1: You have mentioned autologous chondrocyte implantation (Carticel) as one of the techniques that you have developed a particular interest in. Why did you develop faith in Carticel as early as 1997, at a time when it met considerable skepticism in the orthopedic community despite the FDA approval?
Dr. Cole: Actually, I was also very skeptical at first, primarily because of the high cost of the procedure. In comparison to the other less costly procedures, it forces one to question it due to the current healthcare economy. It is also more invasive than other procedures – it requires an arthrotomy incision in front of the knee. Thus, I was very critical of the procedure from the onset and was really hungry to learn what the indications were, how other people were using it and what their experiences were, and how I could potentially bring it into my practice. I was initially exposed to the procedure as a fellow at the University of Pittsburgh and was interested in autologous chondrocyte implantation first from a research perspective to see how it would compare with other more traditional treatments.
Since I have gone into practice, I have made an effort to hone in on the most optimal indications for the procedure. I have co-authored an article in the Journal of Clinical Outcomes Management in an effort to synthesize the existing literature and to come up with various treatment algorithms based upon such factors as the activity level of the patient, the size and the location of the defect, and whether or not they have had prior procedures which attempted to correct the problem. All of us are trying to understand these technologies better, given their expense, their invasiveness and their potential for treatment. I think the greatest thing about Carticel, as well with many other new technologies, is that it offers new opportunities to treat our patients. The potential downside is jumping on the bandwagon too quickly without fully understanding what the indications are, which is the risk with any new technology. And that is one of the reasons why I am happy to be at an academic center, because I feel that we can critically evaluate these indications efficiently because we have the support staff to collect data to see how our patients are doing based on the most current presumed indications.
Knee1: Based on what is known about the procedure today, who in your opinion would be an ideal candidate for autologous chondrocyte implantation?
Dr. Cole: If I had to pinpoint the perfect candidate for Carticel, it would be an individual who is relatively young, less than 35-40 years old, with a knee that has a relatively discrete or localized area of articular cartilage loss, with a mid-size to larger lesion and no other pathology in the knee (so normal meniscus and no other kissing or reciprocal lesions on the opposing articular surfaces). The patient, in my opinion, has to be actively symptomatic; a mere presence of a defect does not warrant the procedure. Additionally, normal alignment of the legs is important, as well as the lack of ligament deficiencies. The patient also needs to be seen as able to tolerate post-operative rehabilitation. Finally, they would likely be someone who had failed an earlier more traditional procedure, such as microfracture. And as I mentioned earlier, many of our patients have tried what we consider to be traditional surgery for this type of problem and now have been referred to us for other options after treatment failure.
Knee1: You alluded to the high cost of the procedure. Do most insurance companies now cover autologous chondrocyte implantation?
Dr. Cole: The majority of insurance plans are now covering it, since the FDA approved it and the 36-month registry data have become available. These data contain some newer information coming out of American institutions demonstrating results similar to those in Sweden, where the initial studies were performed. Given the large number of Carticel patients who have done well and its growing acceptance, it is becoming increasingly difficult for insurance companies to deny this procedure. It varies state by state; in Illinois, 2 out of 3 insurance companies would pay for it, and the numbers are changing rapidly. I think that what is helping this trend is the fact that we now not only better understand the results, but buried in those results is a better understanding of the proper indications for the procedure. I really think it is of fundamental importance for all of us in orthopedic surgery to have a precise understanding of and a commitment to the proper indications for all of the procedures currently in use.
For more information on the Rush Cartilage Restoration Center and contemporary sports medicine, please visit Cartilagedoc.com
To Contact Dr. Cole, please e-mail:
Doctor@Knee1.com
