High failure rate but promising clinical performance after implantation of a flexible medial meniscus prosthesis at 1-year follow-up.
artificial meniscus
clinical investigation
meniscus prosthesis
meniscus replacement
postmeniscectomy pain syndrome
Journal
Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA
ISSN: 1433-7347
Titre abrégé: Knee Surg Sports Traumatol Arthrosc
Pays: Germany
ID NLM: 9314730
Informations de publication
Date de publication:
03 Sep 2024
03 Sep 2024
Historique:
revised:
23
08
2024
received:
05
07
2024
accepted:
25
08
2024
medline:
3
9
2024
pubmed:
3
9
2024
entrez:
3
9
2024
Statut:
aheadofprint
Résumé
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. 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. 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. 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 II.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Subventions
Organisme : ATRO Medical BV
Informations de copyright
© 2024 The Author(s). Knee Surgery, Sports Traumatology, Arthroscopy published by John Wiley & Sons Ltd on behalf of European Society of Sports Traumatology, Knee Surgery and Arthroscopy.
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