Study Underway to Determine the Effectiveness of Collagen Meniscus Implant

June 16, 1999

A national multi-center study is currently underway to determine the effectiveness of collagen implants for regenerating new meniscal cartilage in the knee. The University of Rochester Medical Center’s Strong Memorial Hospital is one of the designated study sites.

Meniscal cartilage, fibrous pads which lie between the femur (thigh bone) and the tibia (shin bone), is an easy target for sports and traumatic injuries. While surgery to remove or repair the torn cartilage is the standard method of treatment, most tears are not repairable, and removal of the torn cartilage often results in knee joint degeneration and pain following surgery.

The study at the University of Rochester Medical Center seeks to determine if a synthetically manufactured implant -- collagen meniscus implant -- will support the regrowth of functional new meniscal cartilage in individuals with an irreparable meniscus tear or loss of meniscus tissue. Collagen is a substance which naturally exists in various tissues of the body and is most abundant in connective tissue. Meniscus cartilage is largely composed of collagen.

"This study holds tremendous promise for individuals suffering from meniscus cartilage damage who are not candidates for meniscus repair," said Kenneth E. DeHaven, M.D., professor and associate chairman of the Department of Orthopaedics and director of athletic medicine at the University of Rochester Medical Center, and principal investigator of the study. "The possible benefits of mensicus cartilage regrowth include not only a decrease in knee pain and restoration of the knee to near normal function, which usually occur after removal of torn cartilage, but regrowth may also prevent degenerative arthritis."

The study will evaluate the success of the procedure versus standard surgical removal. Half of the study participants will be chosen at random to undergo standard surgical removal of the damaged meniscus tissue and insertion of the collagen meniscus implant. The remaining half, the control group, will undergo standard surgical removal of the damaged meniscus tissue only. The study is open to individuals of either sex, who are 18 to 60 years of age and in good health, with a confirmed irreparable medial meniscus cartilage tear. Participants must be willing to make follow-up visits, including second look arthroscopy and biopsy at one year for implant patients, and return for scheduled evaluations. Other UR orthopaedic surgeons participating in the study are Robert D. Bronstein, M.D., Lucien M. Rouse, M.D., and Michael D. Maloney, M.D.

Individuals interested in the study can call the Department of Orthopaedics at (716) 275-7379.

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