The SR-TMC prosthesis is stable after 10 years after implantation.
ID
Bron
Aandoening
RSA; TMC joint; trapeziometacarpal joint arthroplasty; carpometacarpaal; radiostereometrische analyse
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To evaluate implant stability of the SR-TMC prosthesis 10 years after surgery
Achtergrond van het onderzoek
Osteoarthritis of the trapeziometacarpal joint (TMC or 1st carpometacarpal joint; CMC-1) is a disabling disease. Restoration of thumb function with a pain-free, stable, and mobile joint with preserved strength is the main goal of surgical treatment. For degenerated joints as the hip and the knee, total joint arthroplasty has been developed to a successful, reliable and durable treatment strategy with high patient satisfaction. This is not the case with total joint arthroplasty of the TMC joint where most designs are a constrained ball-and-socket joint with a fixed centre of rotation of the prosthesis in the axis of the first metacarpal. This does not reproduce the anatomy of the trapeziometacarpal joint and is prone to early failure due to aseptic loosening. The SR-TMC prosthesis is a resurfacing joint replacement that closely duplicates the anatomy of the articular surfaces of the first metacarpal and trapezium. This prosthesis is supposed to perform better in terms of survival, which is among dependent on implant stability. Implant stability can be assessed with high accuracy using Roentgen Stereophotogrammatric Analysis (RSA). The SR-TMC prosthesis is used in a clinical study (NL22370.098.08) in 10 patients and analysed using RSA. In 2018, these patients will have 10 year follow up.
Primary Objective is to evaluate implant stability of the TMC prosthesis, 10 years after surgery. Secondary Objectives are to monitor improvement of function, pain scores and long term survival after 10 years of TMC prosthesis implantation.
Doel van het onderzoek
The SR-TMC prosthesis is stable after 10 years after implantation.
Onderzoeksopzet
1 follow-up moment at 10-year follow-up (between July and October 2018)
Onderzoeksproduct en/of interventie
Follow-up after implantation of the SR-TMC prosthesis(SRTMTMC, Avanta®, San Diego, CA)
Publiek
N.M.C. Mathijssen
Delft 2525 AD
The Netherlands
+31 (0)15 2603718
N.Mathijssen@rdgg.nl
Wetenschappelijk
N.M.C. Mathijssen
Delft 2525 AD
The Netherlands
+31 (0)15 2603718
N.Mathijssen@rdgg.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Received an SR-TMC joint prosthesis between June and October 2008
-Participated in the study assessing the mid-term results of the SR-TMC joint prosthesis (Ten Brinke et al, 2016)
- Sign informed consent of the proposed study
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Subjects who underwent revision of the CMC-1 prosthesis
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL7126 |
NTR-old | NTR7472 |
CCMO | NL65616.098.18 |
OMON | NL-OMON45754 |
Samenvatting resultaten
Ooms EM, Ten Brinke B, Mathijsen NMS, Blom IF, Deijkers RL, Kraan GA. Feasibility of model-based Roentgen Stereophotogrammetric Analysis to evaluate early migration of the trapeziometacarpal joint prosthesis. BMC Muskuloskelet Disord 2015;16:295