Surgical Treatment for Trapeziometacarpal Osteoarthritis Eaton & Glickel Stage 2-3

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2021-09-30

Brief Summary

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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. A relatively new treatment modality, which has been further developed in recent years is the total joint arthroplasty. Randomized prospective trials and long-term results are lacking, but prospective cohorts show a faster recovery and good results after one year, without an increase in complication rate.

We hypothesize that a total joint arthroplasty gives a better objective and subjective result after one year than a trapeziectomy.

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Detailed Description

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Conditions

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Trapeziometacarpal Osteoarthritis Thumb Carpometacarpal Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Total Joint Arthroplasty

Group Type ACTIVE_COMPARATOR

Total Joint Arthroplasty

Intervention Type PROCEDURE

Total Joint Arthroplasty with device: Maïa® trapezio-metacarpal joint prosthesis, Groupe Lépine, Genay, France

Trapeziectomy

Group Type ACTIVE_COMPARATOR

Trapeziectomy

Intervention Type PROCEDURE

Trapeziectomy

Interventions

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Total Joint Arthroplasty

Total Joint Arthroplasty with device: Maïa® trapezio-metacarpal joint prosthesis, Groupe Lépine, Genay, France

Intervention Type PROCEDURE

Trapeziectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Women.
* 40 years of age or more.
* Symptomatic trapeziometacarpal osteoarthritis.
* Eaton \& Glickel stage 2 and 3.

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.

Minimum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No