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Surgical Treatment for Trapeziometacarpal Osteoarthritis Eaton & Glickel Stage 4

Trapeziectomy With Ligament Reconstruction and Tendon Interposition or Simple Trapeziectomy for Treating Trapeziometacarpal Osteoarthritis Eaton & Glickel Stage 4: a Randomized Clinical Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02204995
Enrollment
62
Registered
2014-07-31
Start date
2014-09-30
Completion date
2021-09-30
Last updated
2016-09-05

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

Conditions

Thumb Carpometacarpal Osteoarthritis, Trapeziometacarpal Osteoarthritis

Keywords

Osteoarthritis, Thumb, LRTI, Trapeziectomy

Brief summary

Trapeziometacarpal osteoarthritis is a common cause of pain and loss of hand function in postmenopausal 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 characterized by more cartilage and soft-tissue damage, which increases the chance for collapse of the first metacarpal bone and associated problems. The investigators' hypothesis is that an LRTI can be of additional value in patients with stage 4 osteoarthritis.

Interventions

PROCEDURETrapeziectomy with LRTI

Trapeziectomy with Ligament Reconstruction and Tendon Interposition

PROCEDURETrapeziectomy

Trapeziectomy

Sponsors

Isala
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
No

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 randomized clinical trial for trapeziometacarpal osteoarthritis with contralateral hand. * 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 outcomes

Primary

MeasureTime frameDescription
Michigan Hand Outcomes Questionnaire (MHOQ)1 year after surgeryIs 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 frameDescription
Disabilities of Arm Shoulder and Hand (DASH)1 and 5 years after surgeryIs 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)?
Grip strength1 and 5 years after surgeryIs there a difference in grip strength between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years?
Michigan Hand Outcomes Questionnaire (MHOQ)5 years after surgeryIs 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)?
Complications1 and 5 years after surgeryIs there a difference in postoperative complications between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years?
Return to work1 and 5 years after surgeryIs there a difference in return to work between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years?
Thumb mobility1 and 5 years after surgeryIs 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?

Countries

Netherlands

Contacts

Primary ContactRamon P. de Wildt, MD
r.p.de.wildt@isala.nl

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026