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

NCT04562753 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2023-08-01

No results posted yet for this study

Summary

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,

Conditions

  • First CarpoMetacarpal Osteoartrithis
  • Basal Thumb Osteoartrithis

Interventions

PROCEDURE

Maïa® TMC Prosthesis (Lépine Groupe)

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

PROCEDURE

APL Suspensionplasty

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

Sponsors & Collaborators

  • Hospital Son Espases

    collaborator OTHER

  • Fundació d'investigació Sanitària de les Illes Balears

    lead OTHER_GOV

Principal Investigators

  • Guillem Salva-Coll, MD, PhD · Hospital Son Espases

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04562753 on ClinicalTrials.gov