Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2025-12-30 @ 3:05 PM
Study NCT ID:
NCT05644132
Status:
COMPLETED
Last Update Posted:
2024-08-26
First Post:
2022-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thumb Hemi-Arthroplasty With Natural Kinematics (THANKS) Trial
Sponsor:
Loci Orthopaedics
Organization:
Study Overview
Official Title:
Thumb Hemi-Arthroplasty With Natural Kinematics (THANKS) Trial
Status:
COMPLETED
Status Verified Date:
2024-08
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:
THANKS
Brief Summary:
This clinical trial aims to evaluate the safety and effectiveness of the lnDx Implant in the treatment of thumb base joint arthritis.
This clinical trial hypothesises that implanting the lnDx prosthesis will improve thumb opposition motion, decrease pain and stiffness, and increase grip and pinch strengths of the carpometacarpal joint in patients with thumb base joint arthritis.
Participants will undergo the following measures to assess their clinical performance:
* Hand X-Ray
* Range of Motion - Kapandji opposition score
* Grip strength, lateral pinch and tip pinch
* Visual Analogue Scale (VAS) for Pain
* Quick Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
This clinical trial hypothesises that implanting the lnDx prosthesis will improve thumb opposition motion, decrease pain and stiffness, and increase grip and pinch strengths of the carpometacarpal joint in patients with thumb base joint arthritis.
Participants will undergo the following measures to assess their clinical performance:
* Hand X-Ray
* Range of Motion - Kapandji opposition score
* Grip strength, lateral pinch and tip pinch
* Visual Analogue Scale (VAS) for Pain
* Quick Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: