Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Olecranon Fractures in the Elderly (CROFT2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04670900
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : May 12, 2021
Sponsor:
Information provided by (Responsible Party):
Frede Frihagen, Oslo University Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Olecranon Fracture Procedure: Tension band wiring or plate fixation Procedure: Active non-operative treatment with optional plaster cast Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized non-inferiority multicenter
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Patient instructed not to reveal treatment and to wear long sleeves.
Primary Purpose: Treatment
Official Title: Operative or Non-Operative Treatment of Displaced Fractures of the Elderly - A Nordic Multicenter Randomized Trial
Actual Study Start Date : March 22, 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Oxford Elbow Score [ Time Frame: 52 weeks ]
    Patient reported 12 item form, 0 (worst) to 100 (best possible score)


Secondary Outcome Measures :
  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)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04670900


Contacts
Layout table for location contacts
Contact: Frede Frihagen, PhD +4791332738 ffrihagen@gmail.com
Contact: Kaare S Midtgaard, MD +4793412696 Kaare.midtgaard@gmail.com

Locations
Layout table for location information
Norway
Baerum Hospital Recruiting
Sandvika, Gjettum, Norway
Contact: Ellen Langslet, MD         
Contact: Espen Laudal       ESLAUD@vestreviken.no   
St. Olavs Hospital Recruiting
Trondheim, Trønderlag, Norway
Contact: Lars Gunnar Johnsen, PhD       lars.gunnar.johnsen@ntnu.no   
Arendal Hospital Recruiting
Arendal, Norway
Contact: Knut Erik Mjaaland, PhD       Knut.Erik.Mjaaland@sshf.no   
Haukeland University Hospital Recruiting
Bergen, Norway
Contact: Jostein Skorpa Nilsen, MD       j.skorpa@gmail.com   
Østfold Hospital Trust Recruiting
Grålum, Norway
Contact: Frede Frihagen, PhD    +4791332738    ffrihagen@gmail.com   
Vestre Viken Hospital Trust Recruiting
Hønefoss, Norway, 3511
Contact: Audun Tangerud, MD    +4732803000    audun.tangerud@gmail.com   
Orthopedic Center, Ulleval University Hospital Recruiting
Oslo, Norway, 0408
Diakonhjemmet Hospital Not yet recruiting
Oslo, Norway
Contact: Marius Coucheron, MD    +4799298431    Marius.Coucheron@diakonsyk.no   
Contact: Bugge         
Telemark Hospital Recruiting
Skien, Norway
Contact: Hilde Apold, PhD       hildeapold@gmail.com   
Stavanger University Hospital Recruiting
Stavanger, Norway
Contact: Ane Djuv, PhD       ane.djuv@sus.no   
Tønsberg Hospital Recruiting
Tønsberg, Norway
Contact: Tor Nicolaysen, MD         
Sweden
Akademiska Hospital Not yet recruiting
Uppsala, Sweden
Contact: Greta Snellman, MD       greta.snellman@surgsci.uu.se   
Sponsors and Collaborators
Oslo University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Frede Frihagen, PhD University of Oslo
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Frede Frihagen, Associate professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT04670900    
Other Study ID Numbers: REC2018/88
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: May 12, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publish protocol
Supporting Materials: Study Protocol
Time Frame: Within 12 months
Access Criteria: Open access

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Frede Frihagen, Oslo University Hospital:
Elderly patients
Surgery
Non-operative treatment
Functional outcome
Additional relevant MeSH terms:
Layout table for MeSH terms
Fractures, Bone
Wounds and Injuries