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Recruiting NCT04401462

Scandinavian Olecranon Research in the Elderly

No phase Interventional Olecranon Fracture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tension band wiring or plate fixation, Sling or a long-arm plaster.
Who it may be relevant to
Registry conditions: Olecranon Fracture. Basic parameters: from 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Finland, Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

SCORE Trial - Scandinavian Olecranon Research in the Elderly

Overview

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.

Interventions

  • Procedure Tension band wiring or plate fixation
    Operative fixation of olecranon fracture with either of the methods mentioned in the intervention name
  • Behavioral 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.

Primary outcome measures

  • the Disabilities of Arm, Shoulder and Hand (DASH) [Time frame: 1 year]
Secondary outcome measures (8)
  • the Disabilities of Arm, Shoulder and Hand (DASH) [Time frame: 3 months]
  • Patient Rated Elbow Evaluation (PREE) Finnish, Swedish and Danish versions [Time frame: 3 and 12 months]
  • Pain, visual analogue scale (VAS) [Time frame: 3 and 12 months]
  • Satisfaction, visual analogue scale (VAS) [Time frame: 3 and 12 months]
  • Elbow X-rays [Time frame: post-operatively, 2 weeks, 3 and 12 months]
  • Range of elbow motion. [Time frame: 3 and 12 months]
  • Comparison of extension strength between injured and healthy elbow. [Time frame: 12 months]
  • Adverse events [Time frame: up to 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Finland · 3 centers
  • Turku Central University Hospital — Turku
  • Hospital Nova — Jyväskylä
  • Tampere University Hospital — Tampere
Sweden · 1 center
  • Danderyd Hospital — Stockholm

Publications

  • 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. PMID 35105643

Identifiers

NCT: NCT04401462 · SCORE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗