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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Rizarthrosis grade I, II, III

Locations
Other Locations
Spain
Hospital del Mar
RECRUITING
Barcelona
Contact Information
Primary
Daniel Valverde Vilamala
dvalverde@hmar.cat
+34 626330598
Time Frame
Start Date: 2022-06-01
Estimated Completion Date: 2025-11-01
Participants
Target number of participants: 61
Treatments
Experimental: Maia Prosthesis group
Experimental: Trapeziectomy and Burton-Pellegrini technique
Remove the trapezium bone and perform a suspensionplasty using a hemi-slip of the flexor carpi radialis tendon
Related Therapeutic Areas
Sponsors
Leads: Parc de Salut Mar

This content was sourced from clinicaltrials.gov