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NCT Number: NCT04401462

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.

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Key information

Conditions

Olecranon Fracture Arm Injuries Elbow Fractures Elbow Injuries Forearm Injuries Fractures, Bone Ulna Fractures Wounds and Injuries

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Turku Central University Hospital, Turku, Southwest Finland, Finland

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tension band wiring or plate fixation

Procedure

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

Sling or a long-arm plaster

Behavioral

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

Primary outcomes

  1. the Disabilities of Arm, Shoulder and Hand (DASH)

    Time frame: 1 year

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

Secondary outcomes

  1. the Disabilities of Arm, Shoulder and Hand (DASH)

    Time frame: 3 months

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

  2. 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. 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.

  4. 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.

  5. Elbow X-rays

    Time frame: post-operatively, 2 weeks, 3 and 12 months

    AP and lateral view.

  6. Range of elbow motion.

    Time frame: 3 and 12 months

    The results are reported in degrees. Measurement is performed to the injured arm.

  7. 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.

  8. Adverse events

    Time frame: up to 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Ida Rantalaiho, MD

CONTACT

[email protected]

+35823135040

Inari Laaksonen, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Collaborators

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

Registry information

Official study title

SCORE Trial - Scandinavian Olecranon Research in the Elderly

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
May 26, 2020
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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