Treatment of Olecranon Fractures in the Elderly

NCT ID: NCT04670900

Last Updated: 2025-03-25

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-22

Study Completion Date

2025-06-30

Brief Summary

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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

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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

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Olecranon Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized non-inferiority multicenter
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Patient instructed not to reveal treatment and to wear long sleeves.

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.

Group Type ACTIVE_COMPARATOR

Tension band wiring or plate fixation

Intervention Type PROCEDURE

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

Group Type EXPERIMENTAL

Active non-operative treatment with optional plaster cast

Intervention Type PROCEDURE

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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Frede Frihagen

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Vestre Viken Hospital Trust

Hønefoss, Norway, Norway

Site Status RECRUITING

St. Olavs Hospital

Trondheim, Trønderlag, Norway

Site Status RECRUITING

Arendal Hospital

Arendal, , Norway

Site Status RECRUITING

Haukeland University Hospital

Bergen, , Norway

Site Status RECRUITING

Østfold Hospital Trust

Grålum, , Norway

Site Status RECRUITING

Orthopedic Center, Ulleval University Hospital

Oslo, , Norway

Site Status RECRUITING

Diakonhjemmet Hospital

Oslo, , Norway

Site Status NOT_YET_RECRUITING

Telemark Hospital

Skien, , Norway

Site Status RECRUITING

Stavanger University Hospital

Stavanger, , Norway

Site Status RECRUITING

Tønsberg Hospital

Tønsberg, , Norway

Site Status RECRUITING

Akademiska Hospital

Uppsala, , Sweden

Site Status NOT_YET_RECRUITING

Countries

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Norway Sweden

Central Contacts

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Frede Frihagen, PhD

Role: CONTACT

+4791332738

Kaare S Midtgaard, MD

Role: CONTACT

+4793412696

Facility Contacts

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Ellen Langslet, MD

Role: primary

Espen Laudal

Role: backup

Audun Tangerud, MD

Role: primary

+4732803000

Lars Gunnar Johnsen, PhD

Role: primary

Knut Erik Mjaaland, PhD

Role: primary

Jostein Skorpa Nilsen, MD

Role: primary

Frede Frihagen, PhD

Role: primary

+4791332738

Marius Coucheron, MD

Role: primary

+4799298431

Bugge

Role: backup

Hilde Apold, PhD

Role: primary

Ane Djuv, PhD

Role: primary

Tor Nicolaysen, MD

Role: primary

Greta Snellman, 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.

Reference Type BACKGROUND
PMID: 32818066 (View on PubMed)

Other Identifiers

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REC2018/88

Identifier Type: -

Identifier Source: org_study_id

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