Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2026-02-20 @ 6:49 PM
Study NCT ID:
NCT02204995
Status:
UNKNOWN
Last Update Posted:
2016-09-05
First Post:
2014-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical Treatment for Trapeziometacarpal Osteoarthritis Eaton & Glickel Stage 4
Sponsor:
Isala
Organization:
Study Overview
Official Title:
Trapeziectomy With Ligament Reconstruction and Tendon Interposition or Simple Trapeziectomy for Treating Trapeziometacarpal Osteoarthritis Eaton & Glickel Stage 4: a Randomized Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2016-09
Last Known Status:
RECRUITING
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:
None
Brief Summary:
Trapeziometacarpal osteoarthritis is a common cause of pain and loss of hand function in postmenopausal women. Many surgical treatments have been described and recent literature has show that the relatively simple trapeziectomy gives equal results and less complications, when compared to other techniques such as ligament reconstructions and interpositions. These studies have been conducted predominantly in patients with stage 2 or 3 osteoarthritis. Stage 4 osteoarthritis is characterized by more cartilage and soft-tissue damage, which increases the chance for collapse of the first metacarpal bone and associated problems.
The investigators' hypothesis is that an LRTI can be of additional value in patients with stage 4 osteoarthritis.
The investigators' hypothesis is that an LRTI can be of additional value in patients with stage 4 osteoarthritis.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NL48197.075.14 | REGISTRY | Medical Ethical Review Committee Isala | View |