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Collagen-based meniscal scaffold may ward off the need for additional surgery
A U.S. study found significantly higher survivorship for the collagen meniscus implant.
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SAN FRANCISCO — Patients with previous partial meniscectomies treated with a collagen-based meniscal scaffold may be able to avoid additional surgeries, according to investigators here.
It is estimated that 900,000 partial meniscectomies were performed in the United States in 2005: more surgeries than all the total knee and hip replacements done that year combined.
Control study
During the Arthroscopy Association of North American 26th Annual Meeting, held here, William G. Rodkey, DVM, presented a survivorship analysis of results with the collagen meniscus implant (CMI) [ReGen Biologics] in 77 patients followed for 4 years. Rodkey and his co-investigators defined survivorship as not requiring any unplanned surgery in the same knee.
For the multicentered study, investigators compared the outcomes of patients with at least one to three previous partial meniscectomies who underwent the CMI treatment, to a control group with a similar surgical history and who also had an additional meniscectomy.
“This study confirms that the chronic patients who maintained the CMI for more than 6 months had a decreased need for additional surgeries in their multiply operated knees,” Rodkey said. “The additional tissue resulting from the CMI may limit or decrease the degenerative changes, thus reducing the necessity for additional surgeries.”
According to Rodkey, the CMI is indicated for patients who still have an intact rim of their meniscus, since the surgeon must suture the device there. Meniscal allograft transplantations, on the other hand, are reserved for patients with a total or near total loss of their meniscus.
Patients in the study were not candidates for allografts.
Five patients in the CMI-treated group needed their implants removed before the 6-month follow-up, which left 72 patients whose outcomes investigators compared to the 66 members of the control group.
All patients enrolled in the study had clinical symptoms despite the previous meniscectomies. They ranged in age from 18 to 60 years old.
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Rodkey reported a 93% follow-up at 4 years postop with 6% in the CMI group (four patients) and 18% in the control group (12 patients) needing additional surgery by that time point.
Reoperation risk
“The risk for reoperation for control patients was 3.8 times greater than for CMI patients at 4 years with a confidence interval 1.2 to 12.5. This was statistically significant,” he said.
Survivorship in the CMI group was significantly higher than in the control group (P=.02).
During his presentation, Rodkey showed a Kaplan-Meier survivorship curve illustrating the superiority of the CMI group to the control group at 1, 2, 3 and 4 years follow-up. The control groups tended to drop off more quickly in the early portion of the study, whereas the CMI patients did not have to have their reoperations until later on, he said.
“This study clearly confirms that it is important to preserve as much meniscus as possible at the time of meniscal surgery. This study clearly supports the potentially positive benefit of regrowing and regenerating lost meniscus tissue,” Rodkey said.
The CMI, made of highly purified collagen, received the European CE mark in 2000.
For more information:Reference:
- William G. Rodkey, DVM, is director of basic science research, Steadman-Hawkins Research Foundation. He can be reached at 181 W. Meadow Drive, Suite 1000, Vail, CO 81657, U.S.A.; +1-970-476-8224; e-mail: cartilagedoc@hotmail.com. He has received grant/research support, miscellaneous funding and stock options from ReGen Biologics.
- Briggs KK, Rodkey WG, Steadman JR. Collagen meniscus implant (CMI) decreased the rate of re-operation in chronic patients: A survivorship analysis. #SS-33. Presented at the Arthroscopy Association of North America 26th Annual Meeting. April 26-29, 2007. San Francisco.