NCT04670900

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
2 countries

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

March 22, 2021

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

4 years

First QC Date

December 8, 2020

Last Update Submit

March 21, 2025

Conditions

Olecranon Fracture

Keywords

Elderly patientsSurgeryNon-operative treatmentFunctional outcome

Outcome Measures

Primary Outcomes (1)

  • Oxford Elbow Score

    Patient reported 12 item form, 0 (worst) to 100 (best possible score)

    52 weeks

Secondary Outcomes (13)

  • Range of motion

    6 weeks

  • Range of motion

    12 weeks

  • Range of motion

    52 weeks

  • Elbow extension strength

    6 weeks

  • Elbow extension strength

    12 weeks

  • +8 more secondary outcomes

Study Arms (2)

Operative

ACTIVE COMPARATOR

Patients will be operated according to Orthopedic Trauma Association (OTA) principles with either tension band wiring or plate fixation with an anatomical precontoured plate.

Procedure: Tension band wiring or plate fixation

Non-operative

EXPERIMENTAL

Patients will be offered a plaster cast for 1-2 weeks

Procedure: Active non-operative treatment with optional plaster cast

Interventions

Tension band wiring or plate fixationPROCEDURE

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.

Operative
Active non-operative treatment with optional plaster castPROCEDURE

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.

Non-operative

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Displaced olecranon fracture (Mayo 2A and 2B).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Baerum Hospital

Sandvika, Gjettum, Norway

RECRUITING

Vestre Viken Hospital Trust

Hønefoss, Norway, 3511, 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, 0408, 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

Related Publications (1)

  • 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.

    PMID: 32818066BACKGROUND

MeSH Terms

Conditions

Olecranon Fracture

Condition Hierarchy (Ancestors)

Elbow FracturesElbow InjuriesArm InjuriesWounds and InjuriesUlna FracturesForearm InjuriesFractures, Bone

Study Officials

  • Frede Frihagen, PhD

    University of Oslo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Frede Frihagen, PhD

CONTACT

+4791332738ffrihagen@gmail.com

Kaare S Midtgaard, MD

CONTACT

+4793412696Kaare.midtgaard@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Patient instructed not to reveal treatment and to wear long sleeves.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized non-inferiority multicenter
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

December 8, 2020

First Posted

December 17, 2020

Study Start

March 22, 2021

Primary Completion

April 1, 2025

Study Completion

June 1, 2025

Last Updated

March 25, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

Publish protocol

Shared Documents
STUDY PROTOCOL
Time Frame
Within 12 months
Access Criteria
Open access

Locations

SE(1)NO(11)