Scandinavian Olecranon Research in the Elderly

NCT ID: NCT04401462

Last Updated: 2024-12-04

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

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-05

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Olecranon Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Operative group

tension band wiring or plate fixation

Group Type ACTIVE_COMPARATOR

Tension band wiring or plate fixation

Intervention Type PROCEDURE

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

Non-operative group

conservative treatment

Group Type ACTIVE_COMPARATOR

Sling or a long-arm plaster

Intervention Type BEHAVIORAL

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

Interventions

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Tension band wiring or plate fixation

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

Intervention Type PROCEDURE

Sling or a long-arm plaster

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role collaborator

Oulu University Hospital

OTHER

Sponsor Role collaborator

Kuopio University Hospital

OTHER

Sponsor Role collaborator

University Hospital, Linkoeping

OTHER

Sponsor Role collaborator

Copenhagen University Hospital at Herlev

OTHER

Sponsor Role collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Turku Central University Hospital

Turku, Southwest Finland, Finland

Site Status RECRUITING

Hospital Nova

Jyväskylä, , Finland

Site Status RECRUITING

Tampere University Hospital

Tampere, , Finland

Site Status RECRUITING

Danderyd Hospital

Stockholm, , Sweden

Site Status NOT_YET_RECRUITING

Countries

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Finland Sweden

Central Contacts

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Ida Rantalaiho, MD

Role: CONTACT

+35823135040

Inari Laaksonen, PhD

Role: CONTACT

Facility Contacts

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Ida Rantalaiho

Role: primary

+35823135040

Toni Luokkala

Role: primary

Antti Launonen

Role: primary

Max Gordon

Role: primary

References

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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.

Reference Type DERIVED
PMID: 35105643 (View on PubMed)

Other Identifiers

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SCORE

Identifier Type: -

Identifier Source: org_study_id