Ignite Creation Date:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2025-12-29 @ 4:37 PM
Study NCT ID:
NCT04670900
Status:
RECRUITING
Last Update Posted:
2025-03-25
First Post:
2020-12-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Olecranon Fractures in the Elderly
Sponsor:
Oslo University Hospital
Organization:
Study Overview
Official Title:
Operative or Non-Operative Treatment of Displaced Fractures of the Elderly - a Nordic Multicenter Randomized Trial
Status:
RECRUITING
Status Verified Date:
2025-03
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:
CROFT2
Brief Summary:
Operative treatment, with tension band wiring or plate fixation, will be compared with non-operative treatment of displaced olecranon fractures (Mayo classification 2A and 2B) in patients 75 years or older.
Detailed Description:
Displaced olecranon fractures disrupt the extensor mechanism of the elbow and operative treatment is therefore usually recommended. Tension band wiring (TBW) and plate fixation (PF) are the most common surgical treatment options. Both methods are associated with high complication and reoperation rates, especially in elderly patients. Only one randomized controlled trial has compared operative and non-operative treatment of olecranon fractures in the elderly, but the study was stopped prematurely due to high complication rates in the group treated operatively and remained underpowered for important outcome measures.A few small patient series with non-operatively treated fractures also exist and suggest that it may be a valid alternative to operative treatment
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?:
False
Is an FDA AA801 Violation?: