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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).

NCT07101887 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2025-08-03

No results posted yet for this study

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).

Conditions

  • Rizarthrosis

Interventions

PROCEDURE

Implantation of thumb prosthesis

Replacing the articular surface of the trapezo-metacarpal joint with a socked-ball prosthesis.

PROCEDURE

Burton-Pellegrini technique

Remove the trapezium bone and perform a suspensionplasty using a hemi-slip of the flexor carpi radialis tendon

Sponsors & Collaborators

  • Parc de Salut Mar

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2025-06-30
Completion
2025-11-01

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 NCT07101887 on ClinicalTrials.gov