Rhizarthrosis Surgery and Functional Recovery: Arthroplasty vs. Trapezectomy

Rhizarthrosis Clinical Trial

— TRAPEzE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06078189
• Other study ID #: 2022-A02775-38
• Status: Recruiting
• Start date: November 24, 2023
• Est. completion date: May 2027

Study information

• Verified date: September 2023
• Source: Clinique Bizet
• Contact: Bouchra BENKESSOU, PM
• Phone: 0764486016
• Email: b.benkessou[@]hexagone-santé-paris.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2027
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Age >45 years

2. Symptomatic trapezius-metacarpal osteoarthritis after failure of medical treatment ( night orthosis 3 months + failure of 2 infiltrations/year)

3. Patient who has given his/her consent to participate in the study after being informed by the surgeon,

4. Patient living in France and able to answer the survey alone.

5. Subject affiliated to a social security system or beneficiary of such a system

6. No participation in any other clinical study

Exclusion Criteria:

1. Minor patient

2. Trapezium height < 8 mm

3. Major subject protected by law, under curatorship or guardianship

4. Known allergy to the materials of the medical device

5. Local infection

6. Local skin necrosis or unhealed wound

7. Pregnant or nursing women

Related Conditions & MeSH terms

• Osteoarthritis
• Rhizarthrosis

Intervention

Device:
• HORUS
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

Country	Name	City	State
France	Clinique BIZET	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Clinique Bizet

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patient assessment of the wrist	Quick-Dash score (11 minimum value and 55 is maximum; )	4 weeks
Secondary	patient assessment of the wrist pain	Visual Analogical Assessment score (0 no pain 10 severe pain)	4 weeks