Olecranon FractureNCT04401462
Scandinavian Olecranon Research in the Elderly
A study testing Tension band wiring or plate fixation and Sling or a long-arm plaster in people with Olecranon Fracture, run by Turku University Hospital at 4 sites in 2 countries.
Trial summary
This study is designed to study the difference between operative treatment, either with tension band wiring or plate fixation, and conservative treatment of traumatic, displaced olecranon fractures in elderly population in a non-inferiority study setting. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Olecranon Fracture
- What is being tested?
- Tension band wiring or plate fixation and Sling or a long-arm plaster
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 5 Oct 2020to Dec 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Radiologically (standard AP and lateral radiographs) confirmed, displaced (≥2mm dislocation of the joint surface) fracture of the olecranon
- Age of patient is 75 years or over at the time of the injury
Who cannot join
- A delay more than 2 weeks after traumatic event to the day of intervention
- Mayo type 3 fracture
- Fracture continuation distal to coronoideus
- Other acute fracture or nerve damage of the ipsilateral upper limb
- Old fracture (<6 months) or pseudoarthrosis or unhealed nerve injury of the ipsilateral upper limb
- Open fracture
Show all 11Show fewer
- Pathological fracture
- History of alcoholism, drug abuse, psychological or other emotional problems likely to jeopardize informed consent
- Patient's inability to understand written and spoken Finnish or Swedish or Danish
- Patient's denial for participation or cognitive incapability to provide consent
- Patient physically unfit for surgery
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Inari Laaksonen, PhD contact
4 sites in 2 countries
Finland3 sites, 3 recruiting
- Recruiting
Hospital Nova
Jyväskylä
Toni Luokkala, toni.luokkala@pshyvinvointialue.fi
- Recruiting
Tampere University Hospital
Tampere
Antti Launonen, antti.launonen@loosi.ee
- Recruiting
Turku Central University Hospital
Turku, Southwest Finland, 20700
Ida Rantalaiho, +35823135040, ida.rantalaiho@tyks.fi
Sweden1 site, 1 recruiting
- Not yet recruiting
Danderyd Hospital
Stockholm
Max Gordon, max.gordon@ki.se
About this study
Official title: SCORE Trial - Scandinavian Olecranon Research in the Elderly
This study is designed to study the difference between operative treatment, either with tension band wiring or plate fixation, and conservative treatment of traumatic, displaced olecranon fractures in elderly population in a non-inferiority study setting.
- Conditions
- Olecranon Fracture
- Being tested
- Tension band wiring or plate fixation, Sling or a long-arm plaster
- 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
Operative fixation of olecranon fracture with either of the methods mentioned in the intervention name
Sling or a long-arm plasterBehavioural
Non-operative treatment and progressive range of motion as tolerated. A long-arm plaster will be used, if necessary, for pain relief.
| Study group | Role | What they receive |
|---|---|---|
| Operative group | Active comparator | tension band wiring or plate fixation Receives: Procedure: Tension band wiring or plate fixation |
| Non-operative group | Active comparator | conservative treatment Receives: Behavioral: Sling or a long-arm plaster |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Disabilities of Arm, Shoulder and Hand (DASH)
Minimum value 0, maximum value 100. Higher scores mean worse outcome.
Measured: 1 year
Secondary outcomes (8)
the Disabilities of Arm, Shoulder and Hand (DASH)
Minimum value 0, maximum value 100. Higher scores mean worse outcome.
Measured: 3 months
Patient Rated Elbow Evaluation (PREE) Finnish, Swedish and Danish versions
Minimum value 0, maximum value 100. Higher score indicates more pain and functional disability.
Measured: 3 and 12 months
Pain, visual analogue scale (VAS)
Minimum value 0, maximum value 100. Higher scores mean worse outcome ie. more pain.
Measured: 3 and 12 months
Satisfaction, visual analogue scale (VAS)
Minimum value 0, maximum value 100. Higher scores mean worse outcome ie. less satisfactory situation.
Measured: 3 and 12 months
Elbow X-rays
AP and lateral view.
Measured: post-operatively, 2 weeks, 3 and 12 months
Range of elbow motion.
The results are reported in degrees. Measurement is performed to the injured arm.
Measured: 3 and 12 months
Comparison of extension strength between injured and healthy elbow.
Both arms are measured elbow flexed 60 and 90 degrees. Power is reported in grams. Measurements are performed in sitting position, back straight.
Measured: 12 months
Adverse events
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start5 Oct 2020
- Primary completionDec 2027 (estimated)
- Study completionDec 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.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- Helsinki University Central Hospital, Oulu University Hospital, Kuopio University Hospital, University Hospital, Linkoeping, Copenhagen University Hospital at Herlev
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04401462
- Sponsor's protocol ID
- SCORE
- Status last verified
- Nov 2024
- First submitted
- 19 May 2020
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rantalaiho I, Laaksonen I, Launonen AP, Luokkala T, Flinkkila T, Salmela M, Adolfsson L, Olsen B, Isotalo K, Ryosa A, Aarimaa V; SCORE study group. Scandinavian Olecranon Research in the Elderly (SCORE): protocol for a non-inferiority, randomised, controlled, multicentre trial comparing operative and conservative treatment of olecranon fractures in the elderly. BMJ Open. 2022 Jan 31;12(1):e055097. doi: 10.1136/bmjopen-2021-055097.
PubMed 35105643
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCORE Trial - Scandinavian Olecranon Research in the Elderly
- ClinicalTrials.gov ID
- NCT04401462
- Acronym / sponsor ID
- SCORE
- Conditions
- Olecranon Fracture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- Helsinki University Central Hospital, Oulu University Hospital, Kuopio University Hospital, University Hospital, Linkoeping, Copenhagen University Hospital at Herlev
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 26 May 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.
This study is designed to study the difference between operative treatment, either with tension band wiring or plate fixation, and conservative treatment of traumatic, displaced olecranon fractures in elderly population in a non-inferiority study setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Operative group | Active comparator | Procedure: Tension band wiring or plate fixationtension band wiring or plate fixation |
| Non-operative group | Active comparator | Behavioral: Sling or a long-arm plasterconservative treatment |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Radiologically (standard AP and lateral radiographs) confirmed, displaced (≥2mm dislocation of the joint surface) fracture of the olecranon
- Age of patient is 75 years or over at the time of the injury
Key exclusion criteria (11 listed)
- A delay more than 2 weeks after traumatic event to the day of intervention
- Mayo type 3 fracture
- Fracture continuation distal to coronoideus
- Other acute fracture or nerve damage of the ipsilateral upper limb
- Old fracture (<6 months) or pseudoarthrosis or unhealed nerve injury of the ipsilateral upper limb
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 fixationOperative fixation of olecranon fracture with either of the methods mentioned in the intervention name | Procedure or surgery | Operative group |
| Sling or a long-arm plasterNon-operative treatment and progressive range of motion as tolerated. A long-arm plaster will be used, if necessary, for pain relief. | Behavioural | Non-operative group |
Primary outcome
the Disabilities of Arm, Shoulder and Hand (DASH)
Time frame: 1 year
Minimum value 0, maximum value 100. Higher scores mean worse outcome.
8 secondary outcomes
the Disabilities of Arm, Shoulder and Hand (DASH)
Time frame: 3 months
Patient Rated Elbow Evaluation (PREE) Finnish, Swedish and Danish versions
Time frame: 3 and 12 months
Pain, visual analogue scale (VAS)
Time frame: 3 and 12 months
Satisfaction, visual analogue scale (VAS)
Time frame: 3 and 12 months
Elbow X-rays
Time frame: post-operatively, 2 weeks, 3 and 12 months
Range of elbow motion.
Time frame: 3 and 12 months
Comparison of extension strength between injured and healthy elbow.
Time frame: 12 months
Adverse events
Time frame: up to 12 months
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 4 Dec 2024.
- Derived from this study: PubMed 35105643Rantalaiho I, Laaksonen I, Launonen AP, Luokkala T, Flinkkila T, Salmela M, Adolfsson L, Olsen B, Isotalo K, Ryosa A, Aarimaa V; SCORE study group. Scandinavian Olecranon Research in the Elderly (SCORE): protocol for a non-inferiority, randomised, controlled, multicentre trial comparing operative and conservative treatment of olecranon fractures in the elderly. BMJ Open. 2022 Jan 31;12(1):e055097. doi: 10.1136/bmjopen-2021-055097.
- Individual participant dataSharing planned: No
Related trials for Olecranon Fracture
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Comparison of Functional Outcomes Between Triceps Tongue Elevation vs Olecranon Osteotomy in Intra Articular Distal Humerus Fracture (IA-DH) Management
Intra Articular Distal Humerus Fracture
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This is a Study to Find Out Whether Surgery Using a Metal Plate to Fix a Broken Elbow in Older Adults Leads to Better Recovery and Arm Function Compared to Non-surgical Treatment
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The With Or Without Olecranon K-wires Trial
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EASY Algorithm Trial (Elbow Trauma Assessment Using Sonography in Children and Youth) Diagnostic Accuracy and Safety of Point-of-care Ultrasound as a Screening Tool for Suspected Elbow Fractures in Children Aged 5 to 15 Years: a Multicenter Prospective Cohort Study
Elbow Fractures, Distal Humerus Fracture
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.
Inari Laaksonen, PhD contact
4 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 Sling or a long-arm plaster in people with Olecranon Fracture, run by Turku University Hospital at 4 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 2 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Finland, 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?
Contact Ida Rantalaiho, MD (+35823135040, ida.rantalaiho@tyks.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Disabilities of Arm, Shoulder and Hand (DASH) (time frame: 1 year). 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 NCT04401462, 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 4 Dec 2024.