Clinical Trial to Estimate the Efficacy of the Trapezium-Metacarpal (TMC) Prosthesis Compared to Suspensionplasty.

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

RECRUITING

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2025-12-31

Brief Summary

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The main objective of the study is to evaluate the efficacy, safety and cost-utility of the Trapezium-Metacarpal (TMC) prosthesis against Suspensionplasty with Abductor Pollicis Longus (APL) for the treatment of patients with first carpometacarpal (CMC) joint osteoarthritis (OA). Patients will be allocated to one of these two groups:

1. Maïa® TMC prosthesis (Groupe Lépine TM).
2. APL Supensionplasty

We will collect patient data using the questionnaires administeredat baseline and after the treatment. The primary outcome will be pain measured by visual analogue scale (VAS) and secondary outcomes will include health-related quality of life measured by EuroQuol 5D questionnaire,

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Detailed Description

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First Carpometacarpal joint osteoarthritis (CMC-OA) is a common problem, being the second location of degenerative osteoarthritis in the hand. The pain, weakness, and swelling cause considerable interference in the activities of daily living, especially in activities that involve repetitive fist-clamp movements.

The conservative treatment available (pain killers, physiotherapy and splints) do not always manage to achieve complete remission of the symptoms or prevent its recurrence. There are several surgical techniques to treat osteoarthritis of the first CMC. The most common surgical treatments used are prosthetic joint replacement and trapeziectomy. The later can be done as an isolated procedure or associated with tendon interposition, ligament reconstruction or both. The preference for indication for one treatment or another is based on personal experience rather than on the available studies, which are highly heterogeneous.

In addition, the direct and indirect costs (those associated with productivity losses as a result of sick leave from the perspective of society) associated with the use of a CMC prosthesis remain unknown, with the shorter recovery time being one of the reasons for its implantation.

The main objective of the study is to determine whether the trapeziometacarpal prosthesis is more effective, safe and cost-effective than suspension suspensionplasty. The secondary objective is to evaluate the functional outcome and estimate the indirect costs and the incremental cost-effectiveness and cost-utility (efficiency) ratios of the trapeziometacarpal prosthesis with respect to suspensionplasty as a treatment for osteoarthritis of the basal thumb joint.

The primary outcome will be measured using the Visual Analogue Scale (VAS). Secondary outcomes will include Quick-DASH and health-related quality of life measured using the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) and. In addition, we will collect direct and indirect costs.

Conditions

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First CarpoMetacarpal Osteoartrithis Basal Thumb Osteoartrithis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Maïa® TMC Prosthesis (Lépine Groupe)

Patients undergoing thumb basal joint arthroplasty using Maïa® TMC prosthesis as treatment of osteoarthritis.

Group Type ACTIVE_COMPARATOR

Maïa® TMC Prosthesis (Lépine Groupe)

Intervention Type PROCEDURE

Patients undergoing thumb basal joint arthroplasty using Maïa® TMC prosthesis as treatment of osteoarthritis.

APL Suspensionplasty

Patients undergoing thumb basal joint arthroplasty using APL Suspensionplasty as treatment of osteoarthritis.

Group Type ACTIVE_COMPARATOR

APL Suspensionplasty

Intervention Type PROCEDURE

Patients undergoing thumb basal joint arthroplasty using APL Suspensionplasty as treatment of osteoarthritis.

Interventions

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Maïa® TMC Prosthesis (Lépine Groupe)

Patients undergoing thumb basal joint arthroplasty using Maïa® TMC prosthesis as treatment of osteoarthritis.

Intervention Type PROCEDURE

APL Suspensionplasty

Patients undergoing thumb basal joint arthroplasty using APL Suspensionplasty as treatment of osteoarthritis.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Individuals aged 18 or older.
* Diagnosis of First CMC OA.
* Non-responses to conservative treatment.
* Eaton Stage 2-3
* Physical and cognitive aptitudes to understand and give written informed consent.

Exclusion Criteria

* Comorbidity with other medical conditions which would affect the hand (Carpal Tunnel Syndrome, De Quervain Tenosynovitis, Trigger Finger)
* Rheumatoid Arthritis
* Previous surgery in the same hand.
* Rejection to participate

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No