Surgical Treatment for Trapeziometacarpal Osteoarthritis Eaton & Glickel Stage 4

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. 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.

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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

NONE

Study Groups

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Trapeziectomy with LRTI

Trapeziectomy with Ligament Reconstruction and Tendon Interposition

Group Type ACTIVE_COMPARATOR

Trapeziectomy with LRTI

Intervention Type PROCEDURE

Trapeziectomy with Ligament Reconstruction and Tendon Interposition

Trapeziectomy

Group Type ACTIVE_COMPARATOR

Trapeziectomy

Intervention Type PROCEDURE

Trapeziectomy

Interventions

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Trapeziectomy with LRTI

Trapeziectomy with Ligament Reconstruction and Tendon Interposition

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 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.

Minimum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No