Scandinavian Olecranon Research in the Elderly

December 2, 2024 updated by: Turku University Hospital

SCORE Trial - Scandinavian Olecranon Research in the Elderly

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Operative group
tension band wiring or plate fixation
Procedure: Tension band wiring or plate fixation
Operative fixation of olecranon fracture with either of the methods mentioned in the intervention name
Active Comparator: Non-operative group
conservative treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the Disabilities of Arm, Shoulder and Hand (DASH)
Time Frame: 1 year
Minimum value 0, maximum value 100. Higher scores mean worse outcome.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the Disabilities of Arm, Shoulder and Hand (DASH)
Time Frame: 3 months
Minimum value 0, maximum value 100. Higher scores mean worse outcome.
3 months
Patient Rated Elbow Evaluation (PREE) Finnish, Swedish and Danish versions
Time Frame: 3 and 12 months
Minimum value 0, maximum value 100. Higher score indicates more pain and functional disability.
3 and 12 months
Pain, visual analogue scale (VAS)
Time Frame: 3 and 12 months
Minimum value 0, maximum value 100. Higher scores mean worse outcome ie. more pain.
3 and 12 months
Satisfaction, visual analogue scale (VAS)
Time Frame: 3 and 12 months
Minimum value 0, maximum value 100. Higher scores mean worse outcome ie. less satisfactory situation.
3 and 12 months
Elbow X-rays
Time Frame: post-operatively, 2 weeks, 3 and 12 months
AP and lateral view.
post-operatively, 2 weeks, 3 and 12 months
Range of elbow motion.
Time Frame: 3 and 12 months
The results are reported in degrees. Measurement is performed to the injured arm.
3 and 12 months
Comparison of extension strength between injured and healthy elbow.
Time Frame: 12 months
Both arms are measured elbow flexed 60 and 90 degrees. Power is reported in grams. Measurements are performed in sitting position, back straight.
12 months
Adverse events
Time Frame: up to 12 months
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turku University Hospital

Collaborators

Helsinki University Central Hospital
Oulu University Hospital
Kuopio University Hospital
Copenhagen University Hospital at Herlev
University Hospital, Linkoeping

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2020

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

May 19, 2020

First Submitted That Met QC Criteria

May 20, 2020

First Posted (Actual)

May 26, 2020

Study Record Updates

Last Update Posted (Actual)

December 4, 2024

Last Update Submitted That Met QC Criteria

December 2, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCORE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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