Objective: Primary Objective is to evaluate implant stability of the TMC prosthesis. Secondary Objectives are to monitor improvement of function, pain scores and long term survivalship after TMC prosthesis implantation.
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: RSA will be used to assess stability of the
prosthesis.
Outcome will be clinically measured using the VAS score, DASH score and Nelson
Hospital Score whilst radiographic outcomes will be evaluated through standard
radiographic parameters which include qualitative trapezium and 1st metacarpal
bone findings as well as position of the components of the prosthesis.
Secondary outcome
not applicable
Background summary
Rationale: Osteoarthritis of the trapeziometacarpal joint (TMC or 1st
carpometacarpal joint; CMC-1) is a disabling disease. Restoration of thumb
function with a painfree, stable, and mobile joint with preserved strength are
the main goals 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. A recently available prosthesis design, 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 o.a.
dependent on implant stability. Implant stability can be assessed with high
accuracy using Roentgen Stereophotogrammatric Analysis (RSA).
Study objective
Objective: Primary Objective is to evaluate implant stability of the TMC
prosthesis.
Secondary Objectives are to monitor improvement of function, pain scores and
long term survivalship after TMC prosthesis implantation.
Study design
Study design: prospective non-randomized cohort study.
Intervention
Intervention: Placement of the SR-TMC prosthesis and insertion of tantalum
beads during the surgery.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: Subjects participating in the study have the
same risks and benefits when not participating in the study. The only
difference is that tantalum beads will be inserted in the bone in the same
surgical procedure to facilitate follow-up with RSA. Follow-up times are
standard protocol evaluations of prosthesis. Besides standard radiological
follow-up, RSA X-rays will be made to assess stability of the prosthesis.
Reinier de Graafweg 3-11
Delft 2625AD
NL
Reinier de Graafweg 3-11
Delft 2625AD
NL
Listed location countries
Age
Inclusion criteria
Radiological staged TMC osteoarthritis Eaton and Littler advanced stage 2 to early 4.
Exclusion criteria
Patients with severe instability of the TMC joint.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL22370.098.08 |