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).

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (estimated)
• Sponsor: Parc de Salut Mar · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2022-06-01
• Primary completion: 2025-06-30
• Completion: 2025-11-01
• First posted: 2025-08-03
• Last updated: 2025-08-03

Locations

1 site across 1 country: Spain