Rhizarthrosis Surgery and Functional Recovery: Arthroplasty vs. Trapezectomy

ConditionRhizarthrosis

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age45-85

SponsorClinique Bizet

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Minor patient

Trapezium height < 8 mm

Major subject protected by law, under curatorship or guardianship

Known allergy to the materials of the medical device

Trial population

Patients with symptomatic disabling osteoarthritis in failure of medical treatment

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

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".

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: Control0 interventions

Group B: Experimental1 intervention

Trial outcomes

Primary outcomes

patient assessment of the wrist

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

Time frame

4 weeks

Secondary outcomes

patient assessment of the wrist pain

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

Time frame

4 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Clinique Bizet

Lead sponsor

Source ClinicalTrials.gov

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