Treatment of Olecranon Fractures in the Elderly (CROFT2)

January 26, 2024 updated by: Frede Frihagen, Oslo University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

76

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

  • Norway
      • Arendal, Norway
      • Bergen, Norway
        • Recruiting
        • Haukeland University Hospital
        • Contact:
      • Grålum, Norway
        • Recruiting
        • Østfold Hospital Trust
        • Contact:
      • Hønefoss, Norway, 3511
        • Recruiting
        • Vestre Viken Hospital Trust
        • Contact:
      • Oslo, Norway, 0408
        • Recruiting
        • Orthopedic Center, Ulleval University Hospital
      • Oslo, Norway
        • Not yet recruiting
        • Diakonhjemmet Hospital
        • Contact:
        • Contact:
          • Bugge
      • Skien, Norway
      • Stavanger, Norway
        • Recruiting
        • Stavanger University Hospital
        • Contact:
      • Tønsberg, Norway
        • Recruiting
        • Tønsberg Hospital
        • Contact:
          • Tor Nicolaysen, MD
    • Gjettum
      • Sandvika, Gjettum, Norway
        • Recruiting
        • Baerum Hospital
        • Contact:
          • Ellen Langslet, MD
        • Contact:
    • Trønderlag
  • Sweden

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

No

Description

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

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Operative
Patients will be operated according to Orthopedic Trauma Association (OTA) principles with either tension band wiring or plate fixation with an anatomical precontoured plate.
Procedure: Tension band wiring or plate fixation
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.
Experimental: Non-operative
Patients will be offered a plaster cast for 1-2 weeks
Procedure: Active non-operative treatment with optional plaster cast
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxford Elbow Score
Time Frame: 52 weeks
Patient reported 12 item form, 0 (worst) to 100 (best possible score)
52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of motion
Time Frame: 6 weeks
Extension, flexion, rotation
6 weeks
Range of motion
Time Frame: 12 weeks
Extension, flexion, rotation
12 weeks
Range of motion
Time Frame: 52 weeks
Extension, flexion, rotation measured in degrees total movement for each direction.
52 weeks
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.
6 weeks
Elbow extension strength
Time Frame: 12 weeks
Strength measured isometrically on a scale (grams) with elbow 30 degrees flexion. Both arms measured for comparison.
12 weeks
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.
52 weeks
Elbow satisfaction
Time Frame: 6 weeks
Single question: Are you satisfied with your elbow? Yes/Somewhat/No
6 weeks
Elbow satisfaction
Time Frame: 12 weeks
Single question: Are you satisfied with your elbow? Yes/Somewhat/No
12 weeks
Elbow satisfaction
Time Frame: 52 weeks
Single question: Are you satisfied with your elbow? Yes/Somewhat/No
52 weeks
Complications
Time Frame: Through study period up to 52 weeks.
Serious local complications not reoperated.
Through study period up to 52 weeks.
Number of Reoperations
Time Frame: Through study period up to 52 weeks.
Any reoperation
Through study period up to 52 weeks.
Oxford Elbow Score
Time Frame: 6 weeks
Patient reported 12 item form, 0 (worst) to 100 (best possible score)
6 weeks
Oxford Elbow Score
Time Frame: 12 weeks
Patient reported 12 item form, 0 (worst) to 100 (best possible score)
12 weeks

Collaborators and Investigators

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

Sponsor

Oslo University Hospital

Investigators

  • Principal Investigator: Frede Frihagen, PhD, University of Oslo

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)

March 22, 2021

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

December 8, 2020

First Submitted That Met QC Criteria

December 15, 2020

First Posted (Actual)

December 17, 2020

Study Record Updates

Last Update Posted (Estimated)

January 29, 2024

Last Update Submitted That Met QC Criteria

January 26, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC2018/88

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Publish protocol

IPD Sharing Time Frame

Within 12 months

IPD Sharing Access Criteria

Open access

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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