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Some of the most common features in patients with knee cartilage problems are their prohibition from participating in clinical trials because the results of the tests may not give the best results for the new methods of cartilage regeneration, according to a study by Penn Medicine published in Regenerative medicine.
Researchers testing new methods tend to include only the patients most likely to succeed with the least possible complications, but if some of these trials could be safely opened to different types of patients -; like those who are over 55 or under 18, or those who have knee joints are not perfectly aligned -; the results could be much more robust and reflect the treated patient population. In the team's paper, they also highlighted particularly promising therapies for excluded populations, such as the use of a "scaffold" to promote cartilage growth.
We invite the orthopedic field to ask if therapies could be effective for patients other than the "perfect" candidate. And if these therapies do not work for these groups, what can we do instead to help them?
Populations affected by these knee anomalies are more numerous than those badessed. We are therefore looking at what can be done to address this, while ensuring that more comprehensive studies are developed. "
Co-Principal, Robert Mauck, PhD, Professor of Orthopedic Surgery and Director of the McKay Orthopedic Research Laboratory at Penn Medicine
In clinical trials of new therapies and techniques for cartilage regeneration, populations may be characterized by "green knees" or "red knees". Green knees are the joints that should benefit the most from the weakest fallout of the particular form of cartilage regeneration tested. Red knees, on the other hand, have defects or features that may make patients more susceptible to complications or slower recovery.
In many clinical trials, researchers will attempt to determine whether or not therapy is the primary endpoint. Our study suggests that once the safety and efficacy of a particular therapy or technique is established, clinical trial teams should consider evaluating it in populations that would benefit the most. . As far as cartilage regeneration is concerned, I think sometimes these therapies need to be pushed to the limit in order to evaluate them more thoroughly and to give physicians more details about the conditions under which they could work best, as well as only on the results to be expected from those who are not perfect. "
Robert Mauck
Mauck and his team, co-led by James L. Carey, MD, badociate professor of orthopedic surgery and director of the Penn Medicine Center for Cartilage Repair and Osteochondritis, have discovered that extremely common conditions are often not common. never included in clinical cartilage regeneration trials. trials. Cartilage regeneration procedures are attractive because they create a living biological tissue that can reshape and function during the patient's life, unlike metals or plastics used in total knee replacement that begin to wear out as soon as possible. their implantation. Researchers consulted the ClinicalTrials.gov database and reviewed 33 regeneration trials. They found that half of them excluded patients over 55 or under 18 years of age. Nearly 60% excluded patients for lesions greater than eight square centimeters, 64% excluded patients with more than one cartilage lesion, and 79% excluded patients with osteoarthritis.
Many studies have also created a "bottleneck" as they struggle to find enough "green knees" to participate, Carey said. He suggested using different study structures to include a wider population and overcome bottleneck problems.
"In prospective cohort studies, everyone is enrolled and the results are observed over time, for example, two, five and ten years," said Carey. "With this you can look back and determine what are the predictors of success and failure.For example, you can look at a patient whose knee alignment has been corrected, which is usually excluded now, and see how far it is factor is in the success or failure of a therapy compared to the optimal candidate ".
The researchers pointed out that the identified therapies were the most promising for various "red knee" conditions. For patients over the age of 55, a technique of eliminating cells that have stopped dividing might give better results. Or, for larger defects, such as lesions larger than 8 square centimeters, 3D printed fabrics could be a lifelong alternative to total knee replacement.
"We want to give more patients the opportunity to repair their joint instead of replacing it completely," said Carey. "Cartilage defects do not occur in isolation, having more clinical data on a greater number of factors will spur more innovation and open the door to a variety of ways to repair joints."
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