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Clinical Trials in Spain / NCT07101887
Recruiting Not applicable

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 · tracked via the Priya Life Science Spain tracker
Sponsor
Parc de Salut Mar
Phase
Not applicable
Started
2022-06-01
Last updated
2025-08-03

Condition(s) studied

Rizarthrosis

Investigational drug(s) / intervention(s)

Implantation of thumb prosthesisBurton-Pellegrini technique

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

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

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).

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Rizarthrosis grade I, II, III Exclusion Criteria: * Rizarthrosis grade IV * Severe osteoporosis * Metals allergy * Previous surgical interventions related * Malformations in the articular zones that difficult the implant placement

Primary outcome measure(s)

  • VAS — 1 year
    Pain evaluated by Visual analogic scale (VAS)
  • Quick Dash — 1 year
    Function of the arm evaluated by Quick Dash scale

Trial sites (1)

FacilityCityRegionStatus
Hospital del Mar Barcelona Spain Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07101887 on ClinicalTrials.gov ↗ ← All trials in Spain