Comparative Study Between the Use of Trapeziometacarpal Prostheses and the Usual Resection-tenosuspension Arthroplasty for the Treatment of Rhizarthrosis, Focusing on Changes in Pain (Measured With the VAS Scale) and Function (With the Quick-DASH).
1 other identifier
interventional
61
1 country
1
Brief Summary
It is a randomized, prospective, single-blind study of two treatment techniques for rhizarthrosis. The patients are divided into two groups: one in which a Maia trapeziometacarpal prosthesis is implanted, and the other in which the standard technique of trapeziectomy and tenosuspension plasty is performed according to the Burton-Pellegrini technique.The follow-up of the patients is one year, and functionality (measured with the Quick Dash test) and pain (measured with the VAS scale) are compared throughout this period.This study has a sample size of 62 patients, 31 per group. Other secondary variables are also evaluated, such as strength and mobility of the thumb trapeziometacarpal joint (measured with the Kapandji index).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedFirst Submitted
Initial submission to the registry
July 28, 2025
CompletedFirst Posted
Study publicly available on registry
August 3, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2025
CompletedAugust 3, 2025
February 1, 2025
3.1 years
July 28, 2025
July 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
VAS
Pain evaluated by Visual analogic scale (VAS)
1 year
Quick Dash
Function of the arm evaluated by Quick Dash scale
1 year
Secondary Outcomes (1)
Strength
1 year
Study Arms (2)
Maia Prosthesis group
EXPERIMENTALTrapeziectomy and Burton-Pellegrini technique
EXPERIMENTALRemove the trapezium bone and perform a suspensionplasty using a hemi-slip of the flexor carpi radialis tendon
Interventions
Replacing the articular surface of the trapezo-metacarpal joint with a socked-ball prosthesis.
Remove the trapezium bone and perform a suspensionplasty using a hemi-slip of the flexor carpi radialis tendon
Eligibility Criteria
You may qualify if:
- Rizarthrosis grade I, II, III
You may not qualify if:
- Rizarthrosis grade IV
- Severe osteoporosis
- Metals allergy
- Previous surgical interventions related
- Malformations in the articular zones that difficult the implant placement
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital del Mar
Barcelona, 08003, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2025
First Posted
August 3, 2025
Study Start
June 1, 2022
Primary Completion
June 30, 2025
Study Completion
November 1, 2025
Last Updated
August 3, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share