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NCT Number: NCT06078189

Rhizarthrosis Surgery and Functional Recovery: Arthroplasty vs. Trapezectomy

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.

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Key information

Conditions

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique BIZET

Paris, 75116, France

Location status: Recruiting

Location contact

Bouchra BENKESSOU, MP

CONTACT

0764486016

Camille ECHALIER, DR

PRINCIPAL_INVESTIGATOR

Jean- Noel GOUBIER, DR

SUB_INVESTIGATOR

About this study

This is a two-center, randomized, prospective, comparative study.

The functional, clinical and radiographic evaluation in the early, medium and long term will make it possible to determine the possible superiority of arthroplasty if it exists.

The close evaluation of the patients during the first 3 months will make it possible to update the superiority of the arthroplasty on the functional recovery in the short term if it exists.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

HORUS

Device

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".

Primary outcomes

  1. patient assessment of the wrist

    Time frame: 4 weeks

    Quick-Dash score (11 minimum value and 55 is maximum

    )

Secondary outcomes

  1. patient assessment of the wrist pain

    Time frame: 4 weeks

    Visual Analogical Assessment score (0 no pain 10 severe pain)

Study contacts

Contact information is provided by the study sponsor or research team.

Bouchra BENKESSOU, PM

CONTACT

b.benkessou@hexagone-santé-paris.fr

0764486016

Sponsors and collaborators

Lead sponsor

Clinique Bizet

Other

Registry information

Official study title

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

Acronym: TRAPEzE

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Oct 11, 2023
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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