Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06654349
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-21
Brief Title:
Short-term Recovery After Trapeziectomy and TMC Prosthesis a Diary Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Short-term Recovery After Trapeziectomy and TMC Prosthesis a Diary Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
THUMB Diary
Brief Summary:
Rationale The trapeziometacarpal TMC joint is one of the most common areas in the hand and wrist to develop osteoarthritis OA Currently the two most widely used procedures are the trapeziectomy and the TMC-joint arthroplasty both with their own pros and cons No studies have demonstrated superiority of TMC-joint arthroplasty over gold-standard trapeziectomy And no clinical studies show short-term recovery and patient experience after trapeziectomy or TMC-joint arthroplasty
Objective To gather insight in short-term recovery and patient experience after a trapeziectomy or TMC prosthesis regarding pain pain medication function and quality of life
Study design A prospective observational cohort diary study
Study population In total 200 subjects with TMC-joint osteoarthritis will participate 100 subjects will have trapeziectomy and 100 subjects will have TMC-joint arthroplasty
Main study parametersendpoints The main study parameters are the pain function and quality of life during the first 8 weeks after surgery
Nature and extent of the burden and risks associated with participation benefit and group relatedness Subjects will have no direct benefit from participation in this study Subjects will only complete a diary and questionnaires for this study Therefore we expect no risks from participation The burden for subjects consists of approximately five minutes daily for the diary in the first eight weeks after surgery
Objective To gather insight in short-term recovery and patient experience after a trapeziectomy or TMC prosthesis regarding pain pain medication function and quality of life
Study design A prospective observational cohort diary study
Study population In total 200 subjects with TMC-joint osteoarthritis will participate 100 subjects will have trapeziectomy and 100 subjects will have TMC-joint arthroplasty
Main study parametersendpoints The main study parameters are the pain function and quality of life during the first 8 weeks after surgery
Nature and extent of the burden and risks associated with participation benefit and group relatedness Subjects will have no direct benefit from participation in this study Subjects will only complete a diary and questionnaires for this study Therefore we expect no risks from participation The burden for subjects consists of approximately five minutes daily for the diary in the first eight weeks after surgery
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