RecruitingNCT06078189

Rhizarthrosis Surgery and Functional Recovery: Arthroplasty vs. Trapezectomy

Comparing Short-Term Functional Recovery After Surgery for Rhizarthrosis: Arthroplasty vs. Trapezectomy - A Prospective Randomized Evaluation


Sponsor

Clinique Bizet

Enrollment

50 participants

Start Date

Nov 24, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

Rhizarthrosis is a form of osteoarthritis that affects the trapeziometacarpal joint at the base of the thumb, which is more common in women over 50. Genetic and hormonal factors as well as the frequency of certain physical movements may contribute to its appearance. Surgical treatment is recommended if medical treatment fails, and trapezectomy is currently considered the standard method, although 3rd generation trapeziometacarpal prostheses are also available. The aim of this study is to compare the clinical and radiographic results after surgical treatment of rhizarthrosis: prosthesis versus trapezectomy.


Eligibility

Min Age: 45 YearsMax Age: 85 Years

Inclusion Criteria6

  • Age >45 years
  • Symptomatic trapezius-metacarpal osteoarthritis after failure of medical treatment ( night orthosis 3 months + failure of 2 infiltrations/year)
  • Patient who has given his/her consent to participate in the study after being informed by the surgeon,
  • Patient living in France and able to answer the survey alone.
  • Subject affiliated to a social security system or beneficiary of such a system
  • No participation in any other clinical study

Exclusion Criteria7

  • Minor patient
  • Trapezium height < 8 mm
  • Major subject protected by law, under curatorship or guardianship
  • Known allergy to the materials of the medical device
  • Local infection
  • Local skin necrosis or unhealed wound
  • Pregnant or nursing women

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Interventions

DEVICEHORUS

The trapezium-metacarpal arthroplasty consists of the installation of a bipolar prosthesis composed of a metacarpal implant and a trapezial implant articulated through a metacarpal "head".


Locations(1)

Clinique BIZET

Paris, France

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NCT06078189


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