Research with human participants

Overview of medical research in the Netherlands

In vivo RSA analysis of total joint arthroplasty of the trapezio metacarpal joint of the thumb;
10 yrs follow up.

Published:
Last updated:

Implant stability of the SR-TMC prosthesis, function and pain 10 years after surgery?

Download: PDF | XML
Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Other condition
Study type
Observational invasive

ID

NL-OMON45754

Source

ToetsingOnline

Brief title

RSA in TMC joint replacement, 10 yr FU.

Condition

  • Other condition

Synonym

prosthesis, stability

Health condition

stabiliteit van gewrichtsprothese

Research involving

Human

Sponsors and support

Primary sponsor :
Reinier de Graaf Groep
Source(s) of monetary or material Support :
de Stichting Research Orthopedie Delft vergoedt de kosten voor het polibezoek. Een subsidie zal aangevraagd worden bij de wetenschappelijke activiteitencommissie (WAC) van het RdGG voor de kosten van de rontgenfoto's.

Intervention

Keyword :
10 yr FU, RSA, TMC, Total joint arthroplasty

Outcome measures

Primary outcome

To evaluate implant stability of the TMC prosthesis 10 years after surgery.

Secondary outcome

To monitor improvement of function, pain scores and long term survivalship 10

years after TMC prosthesis implantation

Background summary

Arthrosis of the TMC is a common problem, it can give pain and discomfort. One
of the options is placing a joint replacement prosthesis of the TMC. In
comparison to hip and knee joint replacement prostheses there are few long term
results of the TMC prosthesis.

Study objective

Implant stability of the SR-TMC prosthesis, function and pain 10 years after
surgery?

Study design

Cohort study

Study burden and risks

There are no benefits for patients who take part in this study. all patients
included in our previous study, will be invited for a single visit to our
outpatient clinic of the RdGG Hospital. During this visit clinical assessment
will be done measuring the active and passive range of motion and strength of
the thumb. a RSA radiographs will be made. Patients will be asked to complete
validated questionnaires: VAS score for grading pain, the Dutch version of the
DASH questionnaire and the Nelson Hospital score.

Public
Reinier de Graaf Groep

Reinier de Graafweg 5
Delft 2625 AD
NL
Scientific
Reinier de Graaf Groep

Reinier de Graafweg 5
Delft 2625 AD
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

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
- Sign informed consent of the proposed study

Exclusion criteria

Subjects who underwent a revision of the TMC prosthesis.

Design

Study type :
Observational invasive
Masking :
Open (masking not used)
Control :
Uncontrolled
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
8
Type :
Actual

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Leiden-Den Haag-Delft (Leiden)

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

ID: 21597
Source: NTR
Title: Long-term outcomes after trapeziometacarpal joint arthroplasty: a radiostereometric study with 10 years of follow-up

In other registers

Register ID
CCMO NL65616.098.18
OMON NL-OMON21597