Actively Recruiting

Phase Not Applicable
Age: 75Years +
All Genders
Healthy Volunteers
ID04401462

SCORE Trial - Scandinavian Olecranon Research in the Elderly

Led by Turku University Hospital · Updated on 2024-12-04

68

Participants Needed

4

Research Sites

N/A

Total Duration

On this page

Sponsors

T

Turku University Hospital

Lead Sponsor

H

Helsinki University Central Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the difference between surgical treatment, using tension band wiring or plate fixation, and non-surgical treatment for displaced olecranon fractures in people aged 75 and older. This study focuses on whether non-surgical treatment is not worse than surgery in helping patients recover arm function. The trial is sponsored by Turku University Hospital and aims to improve treatment options for elderly patients with this type of elbow fracture. Participants are randomly assigned to one of two groups: one receiving surgery to fix the fracture with tension band wiring or plate fixation, and the other receiving conservative treatment using a sling or long-arm plaster for pain relief and allowing gradual movement as tolerated. The conservative treatment may include a plaster cast if needed. The study compares these approaches over a year to assess recovery and function. During the study, participants undergo several assessments including questionnaires to measure arm, shoulder, and hand disabilities at 3 months and 1 year, pain and satisfaction scales, elbow X-rays at multiple time points, and tests of elbow motion and strength. Researchers monitor adverse events for up to 12 months. The total participation time includes follow-ups at 2 weeks, 3 months, and 12 months after treatment to fully evaluate recovery.

CONDITIONS

Brief Title

Scandinavian Olecranon Research in the Elderly

Who Can Participate

Age: 75Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Radiologically confirmed displaced olecranon fracture with 2mm or more dislocation of the joint surface
  • Age 75 years or older at the time of injury
Not Eligible

You will not qualify if you...

  • More than 2 weeks delay from injury to intervention day
  • Mayo type 3 fracture
  • Fracture extends distal to the coronoideus
  • Other acute fracture or nerve damage in the same upper limb
  • Old fracture less than 6 months old, pseudoarthrosis, or unhealed nerve injury in the same upper limb
  • Open fracture
  • Pathological fracture
  • History of alcoholism, drug abuse, or psychological/emotional problems that affect consent
  • Inability to understand written and spoken Finnish, Swedish, or Danish
  • Denial to participate or cognitive inability to give consent
  • Physically unfit for surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 2 weeks or until discharge

Participants receive either operative fixation of the olecranon fracture with tension band wiring or plate fixation, or non-operative treatment with a sling or long-arm plaster and progressive range of motion as tolerated.

1 treatment visit (in-person)

Post-operative Follow-up

Duration - Up to 12 months

Participants are monitored through follow-up visits to assess recovery, elbow function, pain, satisfaction, and adverse events.

Visits at post-operative, 2 weeks, 3 months, and 12 months

Trial Site Locations

Total: 4 locations

1

Turku Central University Hospital

Turku, Southwest Finland, Finland, 20700

Actively Recruiting

2

Hospital Nova

Jyväskylä, Finland

Actively Recruiting

3

Tampere University Hospital

Tampere, Finland

Actively Recruiting

4

Danderyd Hospital

Stockholm, Sweden

Not Yet Recruiting

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Research Team

I

Ida Rantalaiho, MD

I

Inari Laaksonen, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

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.

Ida Rantalaiho, Inari Laaksonen, Antti P Launonen...

https://pubmed.ncbi.nlm.nih.gov/35105643