Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
76 participants
INTERVENTIONAL
2021-03-22
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Operative
Patients will be operated according to Orthopedic Trauma Association (OTA) principles with either tension band wiring or plate fixation with an anatomical precontoured plate.
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.
Non-operative
Patients will be offered a plaster cast for 1-2 weeks
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
75 Years
ALL
No
Sponsors
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Oslo University Hospital
OTHER
Responsible Party
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Frede Frihagen
Associate professor
Principal Investigators
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Frede Frihagen, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Oslo
Locations
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Baerum Hospital
Sandvika, Gjettum, Norway
Vestre Viken Hospital Trust
Hønefoss, Norway, Norway
St. Olavs Hospital
Trondheim, Trønderlag, Norway
Arendal Hospital
Arendal, , Norway
Haukeland University Hospital
Bergen, , Norway
Østfold Hospital Trust
Grålum, , Norway
Orthopedic Center, Ulleval University Hospital
Oslo, , Norway
Diakonhjemmet Hospital
Oslo, , Norway
Telemark Hospital
Skien, , Norway
Stavanger University Hospital
Stavanger, , Norway
Tønsberg Hospital
Tønsberg, , Norway
Akademiska Hospital
Uppsala, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Ellen Langslet, MD
Role: primary
Bugge
Role: backup
Tor Nicolaysen, MD
Role: primary
References
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Savvidou OD, Koutsouradis P, Kaspiris A, Naar L, Chloros GD, Papagelopoulos PJ. Displaced olecranon fractures in the elderly: outcomes after non-operative treatment - a narrative review. EFORT Open Rev. 2020 Aug 1;5(7):391-397. doi: 10.1302/2058-5241.5.190041. eCollection 2020 Jul.
Other Identifiers
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REC2018/88
Identifier Type: -
Identifier Source: org_study_id
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