Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07101887

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).

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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Rizarthrosis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital del Mar

Barcelona, 08003, Spain

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implantation of thumb prosthesis

Procedure

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

Burton-Pellegrini technique

Procedure

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

Primary outcomes

  1. VAS

    Time frame: 1 year

    Pain evaluated by Visual analogic scale (VAS)

  2. Quick Dash

    Time frame: 1 year

    Function of the arm evaluated by Quick Dash scale

Secondary outcomes

  1. Strength

    Time frame: 1 year

    Strength evaluated with a pressure gauge

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Valverde Vilamala

CONTACT

[email protected]

+34 626330598

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Registry information

Official study title

Comparative Study Between the Use of Trapeziometacarpal Prostheses and the Usual Resection-tenosuspension Arthroplasty for the Treatment of Rhizarthrosis.

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 3, 2025
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.