Clinical Trial: Long Term Outcomes of Osteochondral Allografts for Osteochondral Defects of the Knee

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Observational

Official Title: Long Term Outcomes of Osteochondral Allografts for Osteochondral Defects of the Knee.

Brief Summary: The purpose of this study is to evaluate the functional and clinical outcomes of patients receiving femoral condyle osteochondral allografts, to evaluate potential predisposing factors to failure of such grafts, and to compare the overall outcomes of the grafts to the current standard of care for smaller lesions, microfracture. Our hypothesis is that patients treated with these allografts will demonstrate significant functional improvement as measured by validated outcome scoring measures and their function will be at least equal to that of microfracture outcomes.

Detailed Summary:

Localized articular cartilage defects are a common and challenging problem, particularly in young patients. These defects cause significant disability and, as participation in sports activity grows, are increasing in overall number annually. A recent systematic review evaluating the overall full-thickness focal chondral defects in athletes revealed the prevalence to be 36%, with 22% of the athletes being symptomatic. As the prevalence of these injuries increases, they pose increasingly significant challenges to the clinicians who treat them.

Normal joint cartilage is a firm, elastic tissue that covers the ends of bones to protect them and allow smooth, pain-free movement over each other. Joint cartilage is described, macroscopically and microscopically, as articular or "hyaline" cartilage. Hyaline cartilage is often described as a "glass-like" structural tissue because of its shiny appearance and translucency. The tissue structure is a hydrated matrix consisting of proteoglycans and at least 90% (dry weight) Type II collagen fibers. The collagen fibers contribute to the overall tensile strength and the proteoglycans provide the stiffness and tissue resiliency. Cartilage cells, or chondrocytes, produce dense matrix, which effectively incarcerate the cells themselves. In the event of injury, the motility of these cells is restricted due to their inclusion deep inside the matrix, and the avascularity of the cartilage itself. This lack of a vascular network prevents the infiltration of inflammatory cells and bioactive molecules following damage. Thus, once damaged, adult articular cartilage will not effectively heal or regenerate.

Treatment techniques of osteochondral lesions are relatively new and frequently changing and evolving. The treatment algorithms for these injuries are complex and often involve mu
Sponsor: University of Missouri-Columbia

Current Primary Outcome:

• Pain Level [ Time Frame: 1 Year ]
  Subject outcomes will be assessed through validated outcomes scoring systems, including the International Knee Documentation Committee (IKDC), the SF-36 health survey and the Tegner activity scale. These will be completed by the participants prior to the index procedure and at the 3, 6 and 12 month visits and yearly thereafter.
• Activity Level [ Time Frame: 1 Year ]
  Subject outcomes will be assessed through validated outcomes scoring systems, including the International Knee Documentation Committee (IKDC), the SF-36 health survey and the Tegner activity scale. These will be completed by the participants prior to the index procedure and at the 3, 6 and 12 month visits and yearly thereafter.

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Missouri-Columbia

Dates:
Date Received: November 14, 2014
Date Started: May 2014
Date Completion:
Last Updated: October 5, 2016
Last Verified: October 2016