NCT04401462

Brief Summary

This study is designed to study the difference between operative treatment, either with tension band wiring or plate fixation, and conservative treatment of traumatic, displaced olecranon fractures in elderly population in a non-inferiority study setting.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
2 countries

4 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Oct 2020Dec 2027

First Submitted

Initial submission to the registry

May 19, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 26, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

October 5, 2020

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

December 4, 2024

Status Verified

November 1, 2024

Enrollment Period

7.2 years

First QC Date

May 19, 2020

Last Update Submit

December 2, 2024

Conditions

Olecranon Fracture

Outcome Measures

Primary Outcomes (1)

  • the Disabilities of Arm, Shoulder and Hand (DASH)

    Minimum value 0, maximum value 100. Higher scores mean worse outcome.

    1 year

Secondary Outcomes (8)

  • the Disabilities of Arm, Shoulder and Hand (DASH)

    3 months

  • Patient Rated Elbow Evaluation (PREE) Finnish, Swedish and Danish versions

    3 and 12 months

  • Pain, visual analogue scale (VAS)

    3 and 12 months

  • Satisfaction, visual analogue scale (VAS)

    3 and 12 months

  • Elbow X-rays

    post-operatively, 2 weeks, 3 and 12 months

  • +3 more secondary outcomes

Study Arms (2)

Operative group

ACTIVE COMPARATOR

tension band wiring or plate fixation

Procedure: Tension band wiring or plate fixation

Non-operative group

ACTIVE COMPARATOR

conservative treatment

Behavioral: Sling or a long-arm plaster

Interventions

Tension band wiring or plate fixationPROCEDURE

Operative fixation of olecranon fracture with either of the methods mentioned in the intervention name

Operative group
Sling or a long-arm plasterBEHAVIORAL

Non-operative treatment and progressive range of motion as tolerated. A long-arm plaster will be used, if necessary, for pain relief.

Non-operative group

Eligibility Criteria

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

You may qualify if:

  • Radiologically (standard AP and lateral radiographs) confirmed, displaced (≥2mm dislocation of the joint surface) fracture of the olecranon
  • Age of patient is 75 years or over at the time of the injury

You may not qualify if:

  • A delay more than 2 weeks after traumatic event to the day of intervention
  • Mayo type 3 fracture
  • Fracture continuation distal to coronoideus
  • Other acute fracture or nerve damage of the ipsilateral upper limb
  • Old fracture (\<6 months) or pseudoarthrosis or unhealed nerve injury of the ipsilateral upper limb
  • Open fracture
  • Pathological fracture
  • History of alcoholism, drug abuse, psychological or other emotional problems likely to jeopardize informed consent
  • Patient's inability to understand written and spoken Finnish or Swedish or Danish
  • Patient's denial for participation or cognitive incapability to provide consent
  • Patient physically unfit for surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Turku Central University Hospital

Turku, Southwest Finland, 20700, Finland

RECRUITING

Hospital Nova

Jyväskylä, Finland

RECRUITING

Tampere University Hospital

Tampere, Finland

RECRUITING

Danderyd Hospital

Stockholm, Sweden

NOT YET RECRUITING

Related Publications (1)

  • Rantalaiho I, Laaksonen I, Launonen AP, Luokkala T, Flinkkila T, Salmela M, Adolfsson L, Olsen B, Isotalo K, Ryosa A, Aarimaa V; SCORE study group. Scandinavian Olecranon Research in the Elderly (SCORE): protocol for a non-inferiority, randomised, controlled, multicentre trial comparing operative and conservative treatment of olecranon fractures in the elderly. BMJ Open. 2022 Jan 31;12(1):e055097. doi: 10.1136/bmjopen-2021-055097.

    PMID: 35105643DERIVED

MeSH Terms

Conditions

Olecranon Fracture

Condition Hierarchy (Ancestors)

Elbow FracturesElbow InjuriesArm InjuriesWounds and InjuriesUlna FracturesForearm InjuriesFractures, Bone

Central Study Contacts

Ida Rantalaiho, MD

CONTACT

+35823135040ida.rantalaiho@tyks.fi

Inari Laaksonen, PhD

CONTACT

inari.laaksonen@tyks.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2020

First Posted

May 26, 2020

Study Start

October 5, 2020

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

December 4, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)FI(3)