Actifit® polyurethane meniscal scaffold: MRI and functional outcomes after a minimum follow-up of 5 years.

ABSTRACT

BACKGROUND: Implantation of the Actifit® polyurethane meniscal scaffold in patients who have pain after partial meniscectomy provides short-term pain relief and better function. But there is a lack of information about medium-term outcomes. The objective of this longitudinal study was to evaluate the MRI and functional outcomes after a minimum follow-up of 5 years. It was hypothesized that the results are stable over time. MATERIAL AND METHODS: Fifteen consecutive patients (8 men, 7 women; mean age 30 years, range 19-47, mean BMI 25) were enrolled in the study between February 2008 and January 2011. Five patients also underwent ACL reconstruction and one underwent mosaicplasty. Nine lateral and six medial Actifit® implants were evaluated prospectively before the surgery and at a minimum of 12, 24 and 60 months' follow-up using a visual analogue scale (VAS) for pain, the objective and subjective IKDC scores, radiological and MRI analysis with measurement of the ICRS score, Genovese score and extrusion. RESULTS: The mean follow-up was 6 years (range 5-8.1). Two patients were lost to follow-up. Three patients were re-operated at 7, 19 and 30 months because they had not improved functionally and the implant appeared damaged on MRI. Partial removal of the implant did not improve the functional outcomes (mean subjective IKDC pre- and post-revision 37.0 vs. 34.9). Two patients were lost to follow-up. In intention to treat (13 cases), the pain (VAS) and subjective IKDC score were improved between the preoperative period and the last follow-up (5.46 vs. 2.92, P=0.007 and 51.2 vs. 66.1, P=0.05). In per protocol (10 cases, failures excluded), the pain (VAS) and subjective IKDC score were improved (5.3 vs. 1.9, P=0.0009; 49.6 vs. 75.4, P=0.002) along with the pain, daily activities and quality of life components of the KOOS (60.6 vs. 86.0, P=0.0008; 70.3 vs. 90.2, P=0.001; 42.7 vs. 71.0, P=0.0058). The functional scores were stable between months 12, 24 and 60. ICRS cartilage score and mean meniscal extrusion were unchanged at the last follow-up (1.6 vs. 1.6 and 2.41 vs. 2.79). In all patients, the meniscal implant had an intermediate signal and reduced size on MRI. DISCUSSION: Despite an abnormal MRI appearance suggesting the meniscal scaffold is not fully mature after 5 years, the functional scores and cartilage status are stable at this time point. However, the failure rate is still high and removing the implant in patients with poor function does not improve the outcome. TYPE OF STUDY Prospective cohort study Level IV.