No registrations found.
ID
Source
Brief title
Health condition
Osteoarthritis of the first carpometacarpal (CMC1) joint
Sponsors and support
Intervention
Outcome measures
Primary outcome
Daily hand function in patients with a total CMC1 joint arthroplasty after 3 months postoperatively, measured with the total score of the Michigan Hand Outcomes Questionnaire (MHOQ).
Secondary outcome
Pain, thumb range of motion, grip- and pinchstrength, complications, additional therapist- or surgeon visits, time to return to work and patient satisfaction.
Background summary
Joint wear of the thumb base or osteoarthritis of the first carpometacarpal (CMC1) joint is a common cause of pain and loss of function of the hand, especially in postmenopausal women. This can lead to severe reduction in quality of life due to limitations in activities of daily life. The prevalence of radiological arthrosis of the thumb base in people above 55 years of age is around 35%. The amount of scientific literature dealing with the application of a CMC1 total joint arthroplasty is very limited, moreover the post-operative approach hardly has been described. There are insufficient comparative studies of the additional value and effectiveness of postoperative hand therapy in thumb base osteoarthritis in general and, more specific, of CMC1 total joint arthroplasty. Aim of this study is to investigate whether postoperative rehabilitation with hand therapy after CMC1 total joint arthroplasty leads to better results than education only in the short term.
Study objective
Supervised rehabilitation with hand therapy in the first three months after total joint arthroplasty is beneficial to education only, in improving functional outcome.
Study design
Preoperatively, 3 months and 1 year postoperatively
Intervention
A historic cohort (resulting from a completed randomized clinical trial ) with standard care (supervised rehabilitation with hand therapy) will be compared with a prospective cohort of people who only received oral and written education about the surgery, the postoperative period and expected recovery process.
Inclusion criteria
Women aged 40 years or older with CMC1 osteoarthritis Eaton Glickel stage II or III (clinical and X-ray findings) who will receive a total CMC1 joint arthroplasty (Maïa® prosthesis, Groupe Lépine, Genay, France) .
Exclusion criteria
- Surgery for trapeziometacarpal osteoarthritis on the same hand in the past.
- Total joint arthroplasty on the contralateral hand in the past.
- Secondary trapeziometacarpal osteoarthritis as result of trauma, rheumatoid arthritis, systemic lupus or gout.
- Symptomatic carpal tunnel syndrome in same hand.
- Symptomatic Quervain's tenosynovitis in same hand.
- Neurological or other disorders of the affected side that can influence postoperative rehabilitation.
- Insufficient knowledge of Dutch language
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL7654 |
| Other | METC Isala, Zwolle : METC180713 |