Trials / Recruiting
RecruitingNCT04670900
Treatment of Olecranon Fractures in the Elderly
Operative or Non-Operative Treatment of Displaced Fractures of the Elderly - a Nordic Multicenter Randomized Trial
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 76 (estimated)
- Sponsor
- Oslo University Hospital · Academic / Other
- Sex
- All
- Age
- 75 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Tension band wiring or plate fixation | Choice of operative treatment is TBW or PF with a precontoured anatomical plate. The treating surgeon decides if TBW or PF is chosen as operative treatment method. The surgeries are performed according to OTA principles by an experienced surgeon, a trauma fellow or a consultant as approved by the participating hospitals. |
| PROCEDURE | Active non-operative treatment with optional plaster cast | Patients allocated to non-operative treatment are offered a back-slab in 60 degrees of flexion for pain-relief. The back-slab is removed 7-14 days following injury. |
Timeline
- Start date
- 2021-03-22
- Primary completion
- 2025-04-01
- Completion
- 2025-06-01
- First posted
- 2020-12-17
- Last updated
- 2025-03-25
Locations
12 sites across 2 countries: Norway, Sweden
Source: ClinicalTrials.gov record NCT04670900. Inclusion in this directory is not an endorsement.