Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04670900

Treatment of Olecranon Fractures in the Elderly

Operative treatment, with tension band wiring or plate fixation, will be compared with non-operative treatment of displaced olecranon fractures (Mayo classification 2A and 2B) in patients 75 years or older.

Recruiting

Interested in participating?

Request Info

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

Baerum Hospital, Sandvika, Gjettum, Norway

Loading trial locations.

About this study

Displaced olecranon fractures disrupt the extensor mechanism of the elbow and operative treatment is therefore usually recommended. Tension band wiring (TBW) and plate fixation (PF) are the most common surgical treatment options. Both methods are associated with high complication and reoperation rates, especially in elderly patients. Only one randomized controlled trial has compared operative and non-operative treatment of olecranon fractures in the elderly, but the study was stopped prematurely due to high complication rates in the group treated operatively and remained underpowered for important outcome measures.A few small patient series with non-operatively treated fractures also exist and suggest that it may be a valid alternative to operative treatment

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Displaced olecranon fracture (Mayo 2A and 2B).

Exclusion criteria

  • Associated fractures in the coronoid process, radial head or distal humerus.
  • Open fracture, Gustilo-Andersen 2 or 3
  • Severe cardiopulmonary disease or other medical condition which contraindicates surgery.
  • Previous injury to or other condition in the elbow with serious functional impairment

Treatment and study plan

Tension band wiring or plate fixation

Procedure

Choice of operative treatment is TBW or PF with a precontoured anatomical plate. The treating surgeon decides if TBW or PF is chosen as operative treatment method. The surgeries are performed according to OTA principles by an experienced surgeon, a trauma fellow or a consultant as approved by the participating hospitals.

Active non-operative treatment with optional plaster cast

Procedure

Patients allocated to non-operative treatment are offered a back-slab in 60 degrees of flexion for pain-relief. The back-slab is removed 7-14 days following injury.

Primary outcomes

  1. Oxford Elbow Score

    Time frame: 52 weeks

    Patient reported 12 item form, 0 (worst) to 100 (best possible score)

Secondary outcomes

  1. Range of motion

    Time frame: 6 weeks

    Extension, flexion, rotation

  2. Range of motion

    Time frame: 12 weeks

    Extension, flexion, rotation

  3. Range of motion

    Time frame: 52 weeks

    Extension, flexion, rotation measured in degrees total movement for each direction.

  4. Elbow extension strength

    Time frame: 6 weeks

    Strength measured isometrically on a scale (grams) with elbow in 30 degrees flexion. Both arms measured for comparison.

  5. Elbow extension strength

    Time frame: 12 weeks

    Strength measured isometrically on a scale (grams) with elbow 30 degrees flexion. Both arms measured for comparison.

  6. Elbow extension strength

    Time frame: 52 weeks

    Strength measured isometrically on a scale (grams) with elbow 30 degrees flexion. Both arms measured for comparison. arms measured for comparison.

  7. Elbow satisfaction

    Time frame: 6 weeks

    Single question: Are you satisfied with your elbow? Yes/Somewhat/No

  8. Elbow satisfaction

    Time frame: 12 weeks

    Single question: Are you satisfied with your elbow? Yes/Somewhat/No

  9. Elbow satisfaction

    Time frame: 52 weeks

    Single question: Are you satisfied with your elbow? Yes/Somewhat/No

  10. Complications

    Time frame: Through study period up to 52 weeks.

    Serious local complications not reoperated.

  11. Number of Reoperations

    Time frame: Through study period up to 52 weeks.

    Any reoperation

  12. Oxford Elbow Score

    Time frame: 6 weeks

    Patient reported 12 item form, 0 (worst) to 100 (best possible score)

  13. Oxford Elbow Score

    Time frame: 12 weeks

    Patient reported 12 item form, 0 (worst) to 100 (best possible score)

Study contacts

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

Frede Frihagen, PhD

CONTACT

[email protected]

+4791332738

Kaare S Midtgaard, MD

CONTACT

[email protected]

+4793412696

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

Operative or Non-Operative Treatment of Displaced Fractures of the Elderly - a Nordic Multicenter Randomized Trial

Acronym: CROFT2

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Dec 17, 2020
Registry last updated
Mar 25, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.