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Total joint arthroplasy or trapeziectomy for treating trapeziometacarpal osteoarthritis stage 2 and 3: a randomized clinical trial

Total joint arthroplasy or trapeziectomy for treating trapeziometacarpal osteoarthritis stage 2 and 3: a randomized clinical trial - Surgical treatment for trapeziometacarpal osteoarthritis stage 2-3

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON40750
Enrollment
62
Registered
2014-06-12
Start date
2014-09-15
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis or joint cartilage wear

Interventions

Total joint arthroplasty or trapeziectomy

Sponsors

Isala Klinieken
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Women. 40 years of age or more. Symptomatic trapeziometacarpal osteoarthritis. Eaton & Glickel stage 2 and 3.

Exclusion criteria

Exclusion criteria: An operation for trapeziometacarpal osteoarthritis on the same hand in the past. Participation in RCT for trapeziometacarpal osteoarthritis with contralateral hand. Secondary trapeziometacarpal osteoarthritis as result of trauma, reumatoid arthritis, systemic lupus or gout. Clinical signs of STT osteoarthritis (tenderness of STT joint on palpation). 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 outcomes

Primary

MeasureTime frame
Is there a difference is daily hand function between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 year postoperatively, measured with the total score of the Michigan Hand Outcomes Questionnaire (MHOQ)?

Secondary

MeasureTime frame
- Is there a difference is daily hand function between patients with a total joint arthroplasty 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 total joint arthroplasty 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 total joint arthroplasty 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 total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years? - Is there a difference in mobility of the thumb between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years? - Is there a difference in postoeprative complications between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years? - Is there a difference in return to work between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years?

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)