The first-generation anatomical medial meniscus prosthesis led to unsatisfactory results: a first-in-human study.
Artificial meniscus
Meniscectomy
Meniscus prosthesis
Meniscus replacement
Post-meniscectomy 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:
Jun 2023
Jun 2023
Historique:
received:
06
04
2022
accepted:
17
10
2022
medline:
16
5
2023
pubmed:
7
11
2022
entrez:
6
11
2022
Statut:
ppublish
Résumé
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. 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. 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. 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 II.
Identifiants
pubmed: 36336744
doi: 10.1007/s00167-022-07205-x
pii: 10.1007/s00167-022-07205-x
pmc: PMC10183417
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
2526-2533Informations de copyright
© 2022. The Author(s).
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