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Treatment of Olecranon Fractures in the Elderly (CROFT2)

Primary Purpose

Olecranon Fracture

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Tension band wiring or plate fixation
Active non-operative treatment with optional plaster cast
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Olecranon Fracture focused on measuring Elderly patients, Surgery, Non-operative treatment, Functional outcome

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baerum HospitalRecruiting
  • St. Olavs HospitalRecruiting
  • Arendal HospitalRecruiting
  • Haukeland University HospitalRecruiting
  • Østfold Hospital TrustRecruiting
  • Vestre Viken Hospital TrustRecruiting
  • Orthopedic Center, Ulleval University HospitalRecruiting
  • Diakonhjemmet Hospital
  • Telemark HospitalRecruiting
  • Stavanger University HospitalRecruiting
  • Tønsberg HospitalRecruiting
  • Akademiska Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Operative

Non-operative

Arm Description

Patients will be operated according to Orthopedic Trauma Association (OTA) principles with either tension band wiring or plate fixation with an anatomical precontoured plate.

Patients will be offered a plaster cast for 1-2 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 8, 2020
Last Updated
September 25, 2022
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04670900
Brief Title
Treatment of Olecranon Fractures in the Elderly
Acronym
CROFT2
Official Title
Operative or Non-Operative Treatment of Displaced Fractures of the Elderly - A Nordic Multicenter Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2021 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Olecranon Fracture
Keywords
Elderly patients, Surgery, Non-operative treatment, Functional outcome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized non-inferiority multicenter
Masking
InvestigatorOutcomes Assessor
Masking Description
Patient instructed not to reveal treatment and to wear long sleeves.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Operative
Arm Type
Active Comparator
Arm Description
Patients will be operated according to Orthopedic Trauma Association (OTA) principles with either tension band wiring or plate fixation with an anatomical precontoured plate.
Arm Title
Non-operative
Arm Type
Experimental
Arm Description
Patients will be offered a plaster cast for 1-2 weeks
Intervention Type
Procedure
Intervention Name(s)
Tension band wiring or plate fixation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Active non-operative treatment with optional plaster cast
Intervention Description
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 Outcome Measure Information:
Title
Oxford Elbow Score
Description
Patient reported 12 item form, 0 (worst) to 100 (best possible score)
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Range of motion
Description
Extension, flexion, rotation
Time Frame
6 weeks
Title
Range of motion
Description
Extension, flexion, rotation
Time Frame
12 weeks
Title
Range of motion
Description
Extension, flexion, rotation measured in degrees total movement for each direction.
Time Frame
52 weeks
Title
Elbow extension strength
Description
Strength measured isometrically on a scale (grams) with elbow in 30 degrees flexion. Both arms measured for comparison.
Time Frame
6 weeks
Title
Elbow extension strength
Description
Strength measured isometrically on a scale (grams) with elbow 30 degrees flexion. Both arms measured for comparison.
Time Frame
12 weeks
Title
Elbow extension strength
Description
Strength measured isometrically on a scale (grams) with elbow 30 degrees flexion. Both arms measured for comparison. arms measured for comparison.
Time Frame
52 weeks
Title
Elbow satisfaction
Description
Single question: Are you satisfied with your elbow? Yes/Somewhat/No
Time Frame
6 weeks
Title
Elbow satisfaction
Description
Single question: Are you satisfied with your elbow? Yes/Somewhat/No
Time Frame
12 weeks
Title
Elbow satisfaction
Description
Single question: Are you satisfied with your elbow? Yes/Somewhat/No
Time Frame
52 weeks
Title
Complications
Description
Serious local complications not reoperated.
Time Frame
Through study period up to 52 weeks.
Title
Number of Reoperations
Description
Any reoperation
Time Frame
Through study period up to 52 weeks.
Title
Oxford Elbow Score
Description
Patient reported 12 item form, 0 (worst) to 100 (best possible score)
Time Frame
6 weeks
Title
Oxford Elbow Score
Description
Patient reported 12 item form, 0 (worst) to 100 (best possible score)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frede Frihagen, PhD
Phone
+4791332738
Email
ffrihagen@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kaare S Midtgaard, MD
Phone
+4793412696
Email
Kaare.midtgaard@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frede Frihagen, PhD
Organizational Affiliation
University of Oslo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baerum Hospital
City
Sandvika
State/Province
Gjettum
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ellen Langslet, MD
First Name & Middle Initial & Last Name & Degree
Espen Laudal
Email
ESLAUD@vestreviken.no
Facility Name
St. Olavs Hospital
City
Trondheim
State/Province
Trønderlag
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lars Gunnar Johnsen, PhD
Email
lars.gunnar.johnsen@ntnu.no
Facility Name
Arendal Hospital
City
Arendal
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Knut Erik Mjaaland, PhD
Email
Knut.Erik.Mjaaland@sshf.no
Facility Name
Haukeland University Hospital
City
Bergen
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jostein Skorpa Nilsen, MD
Email
j.skorpa@gmail.com
Facility Name
Østfold Hospital Trust
City
Grålum
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frede Frihagen, PhD
Phone
+4791332738
Email
ffrihagen@gmail.com
Facility Name
Vestre Viken Hospital Trust
City
Hønefoss
ZIP/Postal Code
3511
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Audun Tangerud, MD
Phone
+4732803000
Email
audun.tangerud@gmail.com
Facility Name
Orthopedic Center, Ulleval University Hospital
City
Oslo
ZIP/Postal Code
0408
Country
Norway
Individual Site Status
Recruiting
Facility Name
Diakonhjemmet Hospital
City
Oslo
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marius Coucheron, MD
Phone
+4799298431
Email
Marius.Coucheron@diakonsyk.no
First Name & Middle Initial & Last Name & Degree
Bugge
Facility Name
Telemark Hospital
City
Skien
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hilde Apold, PhD
Email
hildeapold@gmail.com
Facility Name
Stavanger University Hospital
City
Stavanger
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ane Djuv, PhD
Email
ane.djuv@sus.no
Facility Name
Tønsberg Hospital
City
Tønsberg
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tor Nicolaysen, MD
Facility Name
Akademiska Hospital
City
Uppsala
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Greta Snellman, MD
Email
greta.snellman@surgsci.uu.se

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Publish protocol
IPD Sharing Time Frame
Within 12 months
IPD Sharing Access Criteria
Open access
Citations:
PubMed Identifier
32818066
Citation
Savvidou OD, Koutsouradis P, Kaspiris A, Naar L, Chloros GD, Papagelopoulos PJ. Displaced olecranon fractures in the elderly: outcomes after non-operative treatment - a narrative review. EFORT Open Rev. 2020 Aug 1;5(7):391-397. doi: 10.1302/2058-5241.5.190041. eCollection 2020 Jul.
Results Reference
background

Learn more about this trial

Treatment of Olecranon Fractures in the Elderly

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