Actively Recruiting

Age: 45Years - 85Years
All Genders
ID06078189

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

Led by Clinique Bizet · Updated on 2026-01-06

50

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Rhizarthrosis is a type of osteoarthritis that affects the joint at the base of the thumb and is more common in women over 50. Genetic and hormonal factors, along with certain repetitive movements, may contribute to this condition. When medical treatments do not work, surgery is recommended, with trapezectomy being the standard method, though newer prostheses are also available. This study compares the clinical and X-ray results after surgery using either a prosthesis or trapezectomy to see which offers better recovery and function. The study is a randomized and prospective comparison conducted at two centers. Participants will be assigned to one of two groups: one receiving trapezectomy surgery and the other undergoing trapeziometacarpal arthroplasty with a device called HORUS, a bipolar prosthesis consisting of implants for the metacarpal and trapezium bones. The study includes close evaluations during the first three months and further follow-up to assess early, medium, and long-term outcomes. Participants will have their wrist function and pain assessed, including a primary outcome measure at 4 weeks. Evaluations include clinical and radiographic assessments over time to monitor recovery and function. The study is designed to observe differences in functional recovery and pain relief after the different surgical treatments, with participant involvement spanning the early post-surgery period and beyond to capture comprehensive results.

CONDITIONS

Brief Title

Rhizarthrosis Surgery and Functional Recovery: Arthroplasty vs. Trapezectomy

Who Can Participate

Age: 45Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 45 years
  • Symptomatic trapezius-metacarpal osteoarthritis after medical treatment failure (night orthosis for 3 months plus failure of 2 infiltrations per year)
  • Provided informed consent after explanation by the surgeon
  • Living in France and able to complete surveys independently
  • Affiliated with or beneficiary of a social security system
  • Not participating in any other clinical study
Not Eligible

You will not qualify if you...

  • Underage (minor) patients
  • Trapezium bone height less than 8 mm
  • Individuals under legal protection such as guardianship or curatorship
  • Known allergy to medical device materials
  • Presence of local infection
  • Local skin necrosis or unhealed wounds
  • Pregnant or nursing women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Up to 1 week

Participants undergo either trapezectomy or arthroplasty surgery and receive immediate post-operative care to support recovery.

1 visit (in-person) for surgery and immediate post-operative evaluation

Post-operative Follow-up

Duration - 3 months

Participants are closely evaluated through functional, clinical, and radiographic assessments during the early recovery period.

Weekly visits for up to 12 weeks

Trial Site Locations

Total: 1 location

1

Clinique BIZET

Paris, France, 75116

Actively Recruiting

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Research Team

B

Bouchra BENKESSOU, PM

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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