Clinical Trial to Estimate the Efficacy, Safety and Cost-utility of the Trapezium-Metacarpal (TMC) Prosthesis Compared to Suspensionplasty.

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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,

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Hospital Son Espases
RECRUITING
Palma De Mallorca
Contact Information
Primary
Serafin Lirola-Palmero, MD
slirola@ssib.es
+34 971 205000
Time Frame
Start Date: 2021-05-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 106
Treatments
Active_comparator: Maïa® TMC Prosthesis (Lépine Groupe)
Patients undergoing thumb basal joint arthroplasty using Maïa® TMC prosthesis as treatment of osteoarthritis.
Active_comparator: APL Suspensionplasty
Patients undergoing thumb basal joint arthroplasty using APL Suspensionplasty as treatment of osteoarthritis.
Related Therapeutic Areas
Sponsors
Collaborators: Hospital Son Espases
Leads: Fundació d'investigació Sanitària de les Illes Balears

This content was sourced from clinicaltrials.gov

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