High failure rate but promising clinical performance after implantation of a flexible medial meniscus prosthesis at 1-year follow-up.

PURPOSE: After unsatisfactory results in a first-in-human clinical investigation with an anatomically shaped medial meniscus prosthesis, the prosthesis and its fixation technique were altered. This interim analysis of a prospective single-arm clinical investigation aims to evaluate safety and clinical performance in a first-in-human study with the redesigned meniscus prosthesis system. METHODS: Ten patients suffering from medial postmeniscectomy pain syndrome were treated with the meniscus prosthesis. Patient-reported outcome measures were obtained at baseline and at 6-week, 3-, 6-, and 12-month follow-up. Radiographs and magnetic resonance imaging scans were obtained to evaluate joint degeneration and prosthesis location. RESULTS: The device alterations resolved the issues occurring with the previous design, but four prostheses were explanted after fixation failure or subluxation of the prosthesis. Five out of six patients who reached 1-year follow-up reported a clinically significant improvement of the knee injury and osteoarthritis outcome score pain subscale. Imaging revealed no adverse effects on joint degeneration. CONCLUSION: The failure mechanisms that occurred with the previous design have been resolved, but the new fixation technique introduced new safety issues. Improvement of positioning and fixation techniques are considered essential future adaptations to reduce the risk of failure. The good clinical outcomes reported by the patients reaching 1-year follow-up indicate that the medial meniscus prosthesis is a potential solution for patients suffering from postmeniscectomy pain syndrome. LEVEL OF EVIDENCE: Level II.

The first-generation anatomical medial meniscus prosthesis led to unsatisfactory results: a first-in-human study.

PURPOSE: The purpose of this first-in-human study was to evaluate the effect of a polycarbonate anatomical meniscus prosthesis system, including the surgical procedure, on knee pain and describe potential adverse events in patients with post-meniscectomy pain syndrome. METHODS: Eleven patients with post-meniscectomy pain syndrome and limited underlying cartilage damage were enrolled in the study. Five received a medial polycarbonate urethane meniscus prosthesis which was clicked onto 2 titanium screws fixated at the native horn attachments on the tibia. The KOOS score was planned to be collected at baseline and at 3, 6, 12 and 24 months following the intervention including radiographs at 6, 12 and 24 months. MRI scans were repeated after 12 and 24 months. RESULTS: The surgical technique to select an appropriately sized implant and correct positioning of the fixation screws and meniscus prosthesis onto the tibia was demonstrated to be feasible and reproducible. Inclusion stopped after 5 patients because of serious adverse device-related events. All patients reported knee joint stiffness and slight effusion in their knee at 6 months follow-up. In 3 patients the implant was removed because of implant failure and in 1 patient the implant was removed because of persistent pain and extension limitation. In none of the patients did the KOOS score improve in the first 6 months after surgery. However, in the patient who still has the implant in situ, PROMs started to improve 1 year after surgery and this improvement continued through 2 years of follow-up. The KOOS Pain, symptoms and ADL were close to the maximal 100 points. KOOS QoL and sport did improve but remained suboptimal. CONCLUSION: This first version of the meniscus prosthesis led to impaired knee function and failed in four out of five patients. The patients where the prosthesis was removed were salvable and the PROMs returned to pre-study levels. The results in the patient where the device is still in place are promising. LEVEL OF EVIDENCE: Level II.

The Current State of Meniscus Replacements.

PURPOSE OF REVIEW: The field of meniscus replacement is changing continuously, with new devices emerging and others disappearing from the market. With the current tendency to preserve the knee joint, meniscus implants may become more relevant than ever. The purpose of this review is to provide an overview of the current state of partial and total meniscus replacements that have been developed beyond the academic phase. The available clinical and pre-clinical data is evaluated, and omissions are identified. RECENT FINDINGS: Recent systematic reviews have shown a lack of homogenous clinical data on the CMI and Actifit meniscal scaffolds, especially regarding long-term performance without concomitant surgical interventions. Clinical studies on the medial total meniscus prostheses NUsurface and Artimis are ongoing, with the NUsurface being several years ahead. New techniques for meniscus replacement are rapidly developing, including the Artimis lateral meniscus prosthesis and the MeniscoFix 3D-printed scaffold. All evaluated clinical studies point towards improved clinical outcomes after implantation of partial and total meniscus replacements. Long-term data on survival and performance is of low quality for CMI and Actifit and is unavailable yet for NUsurface and Artimis. It is of major importance that future research focuses on optimizing fixation methods and identifying the optimal treatment strategy for each patient group. New techniques for total and partial replacement of the medial and lateral meniscus will be followed with interest.

The implications of non-anatomical positioning of a meniscus prosthesis on predicted human knee joint biomechanics.

Despite all the efforts to optimize the meniscus prosthesis system (geometry, material, and fixation type), the success of the prosthesis in clinical practice will depend on surgical factors such as intra-operative positioning of the prosthesis. In this study, the aim was therefore to assess the implications of positional changes of the medial meniscus prosthesis for knee biomechanics. A detailed validated finite element (FE) model of human intact and meniscal implanted knees was developed based on a series of in vitro experiments. Different non-anatomical prosthesis positions were applied in the FE model, and the biomechanical response during the gait stance phase compared with an anatomically positioned prosthesis, as well as meniscectomized and also the intact knee model. The results showed that an anatomical positioning of the medial meniscus prosthesis could better recover the intact knee biomechanics, while a non-anatomical positioning of the prosthesis to a limited extent alters the knee kinematics and articular contact pressure and increases the implantation failure risk. The outcomes indicate that a medial or anterior positioning of the meniscus prosthesis may be more forgiving than a posteriorly or laterally positioned prosthesis. The outcome of this study may provide a better insight into the possible consequences of meniscus prosthesis positioning errors for the patient and the prosthesis functionality. Graphical abstract.