Olecranon FractureCROFT2NCT04670900
Treatment of Olecranon Fractures in the Elderly
A study testing Tension band wiring or plate fixation and Active non-operative treatment with optional plaster cast in people with Olecranon Fracture, run by Oslo University Hospital at 12 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Olecranon Fracture
- What is being tested?
- Tension band wiring or plate fixation and Active non-operative treatment with optional plaster cast
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 22 Mar 2021to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Displaced olecranon fracture (Mayo 2A and 2B).
Who cannot join
- 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
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
Norway11 sites
Arendal Hospital
Arendal
Haukeland University Hospital
Bergen
Østfold Hospital Trust
Grålum
Vestre Viken Hospital Trust
Hønefoss, Norway, 3511
Orthopedic Center, Ulleval University Hospital
Oslo, 0408
Diakonhjemmet Hospital
Oslo
Baerum Hospital
Sandvika, Gjettum
Telemark Hospital
Skien
Stavanger University Hospital
Stavanger
Tønsberg Hospital
Tønsberg
St. Olavs Hospital
Trondheim, Trønderlag
About this study
Official title: 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.
Read the 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
- Conditions
- Olecranon Fracture
- Being tested
- Tension band wiring or plate fixation, Active non-operative treatment with optional plaster cast
- Keywords
- Elderly patients, Surgery, Non-operative treatment, Functional outcome
- Medical subject headings
- Olecranon Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tension band wiring or plate fixationProcedure or surgery
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 castProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Operative | Active comparator | Patients will be operated according to Orthopedic Trauma Association (OTA) principles with either tension band wiring or plate fixation with an anatomical precontoured plate. Receives: Procedure: Tension band wiring or plate fixation |
| Non-operative | Experimental | Patients will be offered a plaster cast for 1-2 weeks Receives: Procedure: Active non-operative treatment with optional plaster cast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford Elbow Score
Patient reported 12 item form, 0 (worst) to 100 (best possible score)
Measured: 52 weeks
Secondary outcomes (13)
Range of motion
Extension, flexion, rotation
Measured: 6 weeks
Range of motion
Extension, flexion, rotation
Measured: 12 weeks
Range of motion
Extension, flexion, rotation measured in degrees total movement for each direction.
Measured: 52 weeks
Elbow extension strength
Strength measured isometrically on a scale (grams) with elbow in 30 degrees flexion. Both arms measured for comparison.
Measured: 6 weeks
Elbow extension strength
Strength measured isometrically on a scale (grams) with elbow 30 degrees flexion. Both arms measured for comparison.
Measured: 12 weeks
Elbow extension strength
Strength measured isometrically on a scale (grams) with elbow 30 degrees flexion. Both arms measured for comparison. arms measured for comparison.
Measured: 52 weeks
Elbow satisfaction
Single question: Are you satisfied with your elbow? Yes/Somewhat/No
Measured: 6 weeks
Elbow satisfaction
Single question: Are you satisfied with your elbow? Yes/Somewhat/No
Measured: 12 weeks
Elbow satisfaction
Single question: Are you satisfied with your elbow? Yes/Somewhat/No
Measured: 52 weeks
Complications
Serious local complications not reoperated.
Measured: Through study period up to 52 weeks.
Number of Reoperations
Any reoperation
Measured: Through study period up to 52 weeks.
Oxford Elbow Score
Patient reported 12 item form, 0 (worst) to 100 (best possible score)
Measured: 6 weeks
Oxford Elbow Score
Patient reported 12 item form, 0 (worst) to 100 (best possible score)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start22 Mar 2021
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Olecranon FractureStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized non-inferiority multicenter
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frede Frihagen, Ostfold Hospital Trust
- Investigators
- Frede Frihagen, PhD, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04670900
- Sponsor's protocol ID
- REC2018/88
- Acronym
- CROFT2
- Status last verified
- Oct 2026
- First submitted
- 8 Dec 2020
- Last updated
- 3 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publish protocol
Publications
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.
PubMed 32818066
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operative or Non-Operative Treatment of Displaced Fractures of the Elderly - A Nordic Multicenter Randomized Trial
- ClinicalTrials.gov ID
- NCT04670900
- Acronym / sponsor ID
- CROFT2 / REC2018/88
- Conditions
- Olecranon Fracture
- Keywords
- Elderly patients, Surgery, Non-operative treatment, Functional outcome
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized non-inferiority multicenter
| Arm | Type | Receives |
|---|---|---|
| Operative | Active comparator | Procedure: Tension band wiring or plate fixationPatients will be operated according to Orthopedic Trauma Association (OTA) principles with either tension band wiring or plate fixation with an anatomical precontoured plate. |
| Non-operative | Experimental | Procedure: Active non-operative treatment with optional plaster castPatients will be offered a plaster cast for 1-2 weeks |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Displaced olecranon fracture (Mayo 2A and 2B).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tension band wiring or plate fixationChoice 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. | Procedure or surgery | Operative |
| Active non-operative treatment with optional plaster castPatients 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. | Procedure or surgery | Non-operative |
Primary outcome
Oxford Elbow Score
Time frame: 52 weeks
Patient reported 12 item form, 0 (worst) to 100 (best possible score)
13 secondary outcomes
Range of motion
Time frame: 6 weeks
Range of motion
Time frame: 12 weeks
Range of motion
Time frame: 52 weeks
Elbow extension strength
Time frame: 6 weeks
Elbow extension strength
Time frame: 12 weeks
Elbow extension strength
Time frame: 52 weeks
Elbow satisfaction
Time frame: 6 weeks
Elbow satisfaction
Time frame: 12 weeks
Elbow satisfaction
Time frame: 52 weeks
Complications
Time frame: Through study period up to 52 weeks.
Number of Reoperations
Time frame: Through study period up to 52 weeks.
Oxford Elbow Score
Time frame: 6 weeks
Oxford Elbow Score
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Background: PubMed 32818066Savvidou 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.
- Individual participant dataSharing planned: Yes. Publish protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frede Frihagen, PhD principal investigator
University of Oslo
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tension band wiring or plate fixation and Active non-operative treatment with optional plaster cast in people with Olecranon Fracture, run by Oslo University Hospital at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Norway, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxford Elbow Score (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04670900, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.