Abstract
INTRODUCTION
The purpose of this study is to report results from a prospective multicenter study of a bioresorbable type I collagen scaffold used to replace tissue loss following irreparable lateral meniscus injuries.
METHODS
49 non-consecutive patients (33M/16F; mean age 30.5 yrs, range 14.7–54.7 yrs) with irreparable lateral meniscus tears or loss requiring surgical treatment were prospectively enrolled at one of 7 EU centers. 11 patients (22%) had acute injuries of the lateral meniscus, while 38 (78%) had prior surgeries to the involved meniscus. Implantation of the LCMI (now Lateral Menaflex) was performed arthroscopically using an all-inside suturing technique (FASTFIX) combined with inside-out sutures in the more anterior meniscus aspect. Forty-three patients were evaluated with a 2 to 4-year follow-up (FU); mean FU duration was 45 months (range, 33–53 m). Patients were evaluated clinically and by self-assessment using Tegner activity and Lysholm function scores, as well as the Visual Analog Scales (VAS) for pain, and a satisfaction questionnaire. Evaluations were performed pre-operatively, 6 months, 1 year, 2 and 4 years after surgery. X-ray and/or MR-images were taken pre-operatively, and at 1 year and 2 years after surgery.
RESULTS
At 3 months after surgery, all patients were able to return to activities of daily living without limitation. Post-op. mean values of all evaluated patients showed statistically significant improvement compared to the preoperative scores. Mean Tegner scores increased from 3.0 to 5.2 at 4 years (0.8 points less than the pre-injury “recall” value); mean Lysholm improved from 63 to 91; mean pain (VAS) decreased from 36 to 8. At the 4-year time point, 86% of the patients stated that they were satisfied with their results (compared to 78% at the one year FU time point). Function and pain scores improved continuously with the highest score at the latest FU evaluation. All data were statistically significant (p<0.001, except for Tegner with p=0.03). MRI examination revealed no changes to the articular cartilage and joint space; however, the newly formed tissue did not present a signal consistent with fully mature native meniscus tissue. Reoperations were necessary in 5 patients (10%) during the FU time period: 3 of the reoperations were for persistent swelling and pain, which were classified as related to the device (6%) and were treated by synovectomy and debridement. Patients recovered without sequelae. The re-op. rate in this series is comparable to re-op. rates reported after lateral meniscal repair.
DISCUSSION
Based on available results with a minimum 2 year FU, 90% of the patients benefited from the Lateral Menaflex as evidenced by improved clinical outcomes associated with gains in activity and function. Longer-term FU continues to determine the extent and duration of the benefits observed.
