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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07101887

Enrollment

Registered

2025-08-03

Start date

2022-06-01

Completion date

2025-11-01

Last updated

2025-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rizarthrosis

Keywords

Thumb, osteoarthritis, prosthesis, trapeziectomy

Brief 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).

Interventions

PROCEDUREImplantation of thumb prosthesis

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

PROCEDUREBurton-Pellegrini technique

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
VAS	1 year	Pain evaluated by Visual analogic scale (VAS)
Quick Dash	1 year	Function of the arm evaluated by Quick Dash scale

Secondary

Measure	Time frame	Description
Strength	1 year	Strength evaluated with a pressure gauge

Countries

Spain

Contacts

Primary ContactDaniel Valverde Vilamala

dvalverde@hmar.cat+34 626330598

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026