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).

Parc de Salut Mar

Status: Enrolling

Conditions: Rizarthrosis

Treatments: Procedure: Burton-Pellegrini technique; Procedure: Implantation of thumb prosthesis

Study type: Interventional

Funder types: Other

Identifiers

NCT07101887

2019/8942/I

Details and patient eligibility

About

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).

Enrollment: 61 estimated patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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61 participants in 2 patient groups

Maia Prosthesis group

Experimental group

Treatment:

Procedure: Implantation of thumb prosthesis

Trapeziectomy and Burton-Pellegrini technique

Experimental group

Description:

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

Treatment:

Procedure: Burton-Pellegrini technique