No registrations found.
ID
Source
Health condition
RSA; TMC joint; trapeziometacarpal joint arthroplasty; carpometacarpaal; radiostereometrische analyse
Sponsors and support
Intervention
Outcome measures
Primary outcome
To evaluate implant stability of the SR-TMC prosthesis 10 years after surgery
Secondary outcome
To monitor improvement of function, pain scores and long-term survival 10 years after implantation of the SR-TMC prosthesis.
Background summary
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.
Study objective
The SR-TMC prosthesis is stable after 10 years after implantation.
Study design
1 follow-up moment at 10-year follow-up (between July and October 2018)
Intervention
Follow-up after implantation of the SR-TMC prosthesis(SRTMTMC, Avanta®, San Diego, CA)
N.M.C. Mathijssen
Delft 2525 AD
The Netherlands
+31 (0)15 2603718
N.Mathijssen@rdgg.nl
N.M.C. Mathijssen
Delft 2525 AD
The Netherlands
+31 (0)15 2603718
N.Mathijssen@rdgg.nl
Inclusion criteria
- 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
Exclusion criteria
Subjects who underwent revision of the CMC-1 prosthesis
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL7126 |
NTR-old | NTR7472 |
CCMO | NL65616.098.18 |
OMON | NL-OMON45754 |
Summary results
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