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).

NCT ID: NCT07101887

Last Updated: 2025-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2025-11-01

Brief Summary

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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).

Detailed Description

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Conditions

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Rizarthrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Maia Prosthesis group

Group Type EXPERIMENTAL

Implantation of thumb prosthesis

Intervention Type PROCEDURE

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

Trapeziectomy and Burton-Pellegrini technique

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

Group Type EXPERIMENTAL

Burton-Pellegrini technique

Intervention Type PROCEDURE

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

Interventions

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Implantation of thumb prosthesis

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

Intervention Type PROCEDURE

Burton-Pellegrini technique

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Parc de Salut Mar

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital del Mar

Barcelona, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Daniel Valverde Vilamala

Role: CONTACT

+34 626330598

Other Identifiers

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2019/8942/I

Identifier Type: -

Identifier Source: org_study_id

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