Ignite Creation Date:
2024-05-06 @ 7:37 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06078189
Status:
RECRUITING
Last Update Posted:
2024-02-26
First Post:
2023-04-11
Brief Title:
Rhizarthrosis Surgery and Functional Recovery Arthroplasty vs Trapezectomy
Sponsor:
Clinique Bizet
Organization:
Clinique Bizet
Study Overview
Official Title:
Comparing Short-Term Functional Recovery After Surgery for Rhizarthrosis Arthroplasty vs Trapezectomy - A Prospective Randomized Evaluation
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRAPEzE
Brief 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
The aim of this study is to compare the clinical and radiographic results after surgical treatment of rhizarthrosis prosthesis versus trapezectomy
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None