To research if trapeziectomy with LRTI leads to better results than trapeziectomy on the long term, with subjective and objective outcome measures.
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Is there a difference is daily hand function between patients with a
trapeziectomy with LRTI and patients with a trapeziectomy after 1 year
postoperatively, measured with the total score of the Michigan Hand Outcomes
Questionnaire (MHOQ)?
Secondary outcome
- Is there a difference is daily hand function between patients with a
trapeziectomy with LRTI and patients with a trapeziectomy after 5 years
postoperatively, measured with the total score of the Michigan Hand Outcomes
Questionnaire (MHOQ)?
- Is there a difference is daily hand function between patients with a
trapeziectomy with LRTI and patients with a trapeziectomy after 1 and 5 years
postoperatively, measured with the different subscales (i.e. pain) of the
Michigan Hand Outcomes Questionnaire (MHOQ)?
- Is there a difference is daily hand function after 1 and 5 years
postoperatively between patients with a trapeziectomy with LRTI and patients
with a trapeziectomy measured with the Disabilities of Arm Shoulder and Hand
(DASH)?
- Is there a difference in grip strength between patients with a trapeziectomy
with LRTI and patients with a trapeziectomy after 1 and 5 years?
- Is there a difference in mobility of the thumb between patients with a
trapeziectomy with LRTI and patients with a trapeziectomy after 1 and 5 years?
- Is there a difference in postoeprative complications between patients with a
trapeziectomy with LRTI and patients with a trapeziectomy after 1 and 5 years?
- Is there a difference in return to work between patients with a trapeziectomy
with LRTI and patients with a trapeziectomy after 1 and 5 years?
Background summary
Trapeziometacarpal osteoarthritis is a common cause of pain and loss of hand
function in postmenopauzal women. Many surgical treatments have been described
and recent literature has show that the relatively simple trapeziectomy gives
equal results and less complications, when compared to other techniques such as
ligament reconstructions and interpositions. These studies have been conducted
predominantly in patients with stage 2 or 3 osteoarthritis. Stage 4
osteoarthritis is caracterized by more cartilage and soft-tissue damage, which
increases the chance for collaps of the first metacarpal bone and associated
problems. Our hypothesis is that an LRTI can be of additional value in patients
with stage 4 osteoarthritis.
Study objective
To research if trapeziectomy with LRTI leads to better results than
trapeziectomy on the long term, with subjective and objective outcome measures.
Study design
Longitudinal randomized controlled trial with one preoperative evaluation and
3 postoperative evaluations (after 3 months, 1 year and 5 years)
Intervention
Trapeziectomy with LRTI or trapeziectomy
Study burden and risks
Operating time is a little longer for the LRTI. Rehabilitation with supervised
hand therapy is equal in both treatment protocols. All patients will wear a
plaster cast for 4 weeks. Both groups will begin supervised hand therapy after
the immobilisation fase. This study differs from the standard procedure in the
fact that there are 4 extra examination: preoperatively and 3 months, 1 year
and 5 years postoperatively. The examinations are not physically or mentally
challenging and only take time. The questionnairs will be emailed to the
patients so they can complete them in on a moment they prefer. This reduces
burdening to a minimum.
Dr. van Heesweg 2
Zwolle 8025 AB
NL
Dr. van Heesweg 2
Zwolle 8025 AB
NL
Listed location countries
Age
Inclusion criteria
Women.
40 years of age or more.
Symptomatic trapeziometacarpal osteoarthritis.
Eaton & Glickel stage 4.
Exclusion criteria
An operation for trapeziometacarpal osteoarthritis on the same hand in the past.
Participation in RCT for trapeziometacarpale osteoarthritis for contralateral hand.
Secondary trapeziometacarpal osteoarthritis as result of trauma, reumatoid arthritis, systemic lupus or gout.
Symptomatic carpal tunnel syndrome on same hand.
Symptomatic Quervain's tenosynovitis on same hand.
Neurological or other disorders of the affected side that can influence postoperative rehabilitation.
Insufficient knowledge of Dutch language.
Design
Recruitment
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 | NL48197.075.14 |