Comparing surgical and non-surgical treatments for elbow fractures in older adults
Operative or Non-Operative Treatment of Displaced Fractures of the Elderly - a Nordic Multicenter Randomized Trial
This study is testing whether surgery or non-surgery works better for treating elbow fractures in older adults aged 75 and up.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 75 Years and up |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 12 sites (Sandvika, Gjettum and 11 other locations) |
| Trial ID | NCT04670900 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of surgical treatment options, such as tension band wiring and plate fixation, against non-operative treatment for displaced olecranon fractures in patients aged 75 and older. The goal is to assess functional outcomes and complication rates associated with each treatment approach. Given the high complication rates observed in previous studies, this trial aims to provide clearer guidance on the best treatment for elderly patients with these types of fractures. The study will include patients with specific fracture classifications and exclude those with certain complicating factors.
Who should consider this trial
Good fit: Ideal candidates are elderly patients aged 75 and older with displaced olecranon fractures classified as Mayo 2A and 2B.
Not a fit: Patients with associated fractures, open fractures, severe medical conditions, or previous elbow injuries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence for safer and more effective treatment options for elderly patients with olecranon fractures.
How similar studies have performed: Previous studies have shown mixed results regarding the treatment of olecranon fractures in the elderly, indicating a need for further investigation into both surgical and non-operative approaches.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Displaced olecranon fracture (Mayo 2A and 2B). Exclusion Criteria: * Associated fractures in the coronoid process, radial head or distal humerus. * Open fracture, Gustilo-Andersen 2 or 3 * Severe cardiopulmonary disease or other medical condition which contraindicates surgery. * Previous injury to or other condition in the elbow with serious functional impairment
Where this trial is running
Sandvika, Gjettum and 11 other locations
- Baerum Hospital — Sandvika, Gjettum, Norway (Recruiting)
- Vestre Viken Hospital Trust — Hønefoss, Norway, Norway (Recruiting)
- St. Olavs Hospital — Trondheim, Trønderlag, Norway (Recruiting)
- Arendal Hospital — Arendal, Norway (Recruiting)
- Haukeland University Hospital — Bergen, Norway (Recruiting)
- Østfold Hospital Trust — Grålum, Norway (Recruiting)
- Orthopedic Center, Ulleval University Hospital — Oslo, Norway (Recruiting)
- Diakonhjemmet Hospital — Oslo, Norway (Not_yet_recruiting)
- Telemark Hospital — Skien, Norway (Recruiting)
- Stavanger University Hospital — Stavanger, Norway (Recruiting)
- Tønsberg Hospital — Tønsberg, Norway (Recruiting)
- Akademiska Hospital — Uppsala, Sweden (Not_yet_recruiting)
Study contacts
- Principal investigator: Frede Frihagen, PhD — University of Oslo
- Study coordinator: Frede Frihagen, PhD
- Email: ffrihagen@gmail.com
- Phone: +4791332738
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.