Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06546306
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Post Market Clinical Follow-Up TOUCH CMC 1
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Safety of the Touch Dual Mobility Trapeziometacarpal Prosthesis and Its Surgical Instruments Set in the Treatment of Basal Thumb Osteoarthritis Post-market Observational Clinical Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Because severe pain weakened pinch and grip strength produce functional disabilities the basal joint of the thumb is the most common site of surgical reconstruction in the upper limb due to OA
The cement-free dual mobility Touch prosthesis consists of a metacarpal implant stem a trapezium implant cup and a connection implant neck
The main objective of this study is to describe the performance and safety of the Touch prosthesis used with its instruments set in accordance with its intention and CE marking in force
Performance and safety will be assessed over the short and long term in accordance with the life cycle of the Touch prosthesis
The cement-free dual mobility Touch prosthesis consists of a metacarpal implant stem a trapezium implant cup and a connection implant neck
The main objective of this study is to describe the performance and safety of the Touch prosthesis used with its instruments set in accordance with its intention and CE marking in force
Performance and safety will be assessed over the short and long term in accordance with the life cycle of the Touch prosthesis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None