RecruitingNot ApplicableNCT07101887

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.


Sponsor

Parc de Salut Mar

Enrollment

61 participants

Start Date

Jun 1, 2022

Study Type

INTERVENTIONAL

Conditions

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

Inclusion Criteria1

  • Rizarthrosis grade I, II, III

Exclusion Criteria5

  • Rizarthrosis grade IV
  • Severe osteoporosis
  • Metals allergy
  • Previous surgical interventions related
  • Malformations in the articular zones that difficult the implant placement

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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


Locations(1)

Hospital del Mar

Barcelona, Spain

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NCT07101887