2015 ISAKOS Biennial Congress ePoster #1635

Comparison of the Clinical and Radiological Outcome of the Collagen Meniscus Implant and the Actifit

Clemens Gwinner, MD, Berlin GERMANY
Sophie Wilde, MS, Berlin GERMANY
Sebastian Kopf, MD, PhD, Brandenburg An Der Havel, Brandenburg GERMANY
Arnd T. Hoburg, MD, Berlin GERMANY
Tobias M. Jung, MD, Berlin GERMANY

Department for Sports Traumatology & Knee Arthroscopy Centre for Musculoskeletal Surgery Charité – University Berlin Chairman: Univ.-Prof. Dr. Dr. h. c. N.P. Haas, Berlin, GERMANY

The FDA has not cleared the following pharmaceuticals and/or medical device for the use described in this presentation. The following pharmaceuticals and/or medical device are being discussed for an off-label use: Ivy Sports, CMI; Orteq, Actifit

Summary: While the role of meniscal scaffolds remains controversial, we present clinical and radiological outcomes comparing the CMI and the Actifit.

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Abstract:

Introduction

The importance of the meniscus is widely acknowledged and its preservation is deemed necessary. However, meniscal tears often make a partial or subtotal meniscectomy inevitable.
While allograft transplantation is considered as a well-established option, the role of meniscal scaffolds remains controversial.
The aim of the study is to compare the clinical and radiological outcome of two meniscal scaffolds: the CMI (collagen meniscus implant; Ivy Sports Medicine GmbH, Germany) and the Actifit (Orteq, United Kingdom).

Methods

Out of a total of 46 patients who underwent arthroscopic implantation of one of the two meniscal scaffolds, 18 patients [8f/ 10m, ø40 (23-53 years); 11x CMI and 7x Actifit] were enrolled in this ongoing study so far.
Clinical evaluation included the subjective and objective IKDC 2000, Lysholm, KOOS and Tegner score.
Implant failure such as tears, absorption or insufficiency of the scaffold identified by scaffold extrusion were assessed using MRI.
All statistical analyses were performed using SPSS (SPSS Inc, Chicago, IL, U.S.A.). To evaluate differences between the groups, a nonparametric Mann-Whitney U test was used, with statistical significance set at p<0.05.
Results:The mean clinical follow-up was 25.4 months (± 13).
At time of follow-up, mean subjective IKDC was 60 (± 13) %. Regarding the objective IKDC, five patients accounted for grade A, nine patients for grade B and two patient for grade C. The Lysholm score yielded 67 (± 18) points. Tegner score showed 4.3 (± 1.1). The mean KOOS score reached 70 (± 16) %, respectively, pain 67, symptoms 71, function 80, sports 40 and QoL 41.
Patients with an Actifit scaffold showed overall superior results, when compared to the CMI group, without significant differences in the overall scores (IKDC p=0.4; Lysholm p=0.8; Tegner p=0.1; KOOS p=0.06). KOOS subgroups pain and function showed significant better results for the Actifit group (p<0.05)
MRI assessment confirmed complete absorption of the CMI in two patients, consequently resulting in revision surgery (18% CMI revision rate).

Conclusion

Treatment with meniscal scaffolds provide moderate to good clinical outcome for the post-meniscectomy knee. Preliminary results show favourable results for the Actifit group. The high number of fair clinical results and revision surgeries underlines the need for further improvement in the field of meniscal scaffolds.