Olecranon FractureNCT07400692
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
A study testing Open reduction and plate osteosynthesis and Conservative treatment with early mobilisation in people with Olecranon Fracture, run by Ente Ospedaliero Cantonale, Bellinzona at 1 site in Switzerland.
Trial summary
This study takes place in one hospital and uses a random method to divide patients into groups. It looks at the best way to treat a broken elbow (specifically, a displaced olecranon fracture) in older adults who don't use their arms heavily. There are 84 patients in total, with 42 people in each group Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Olecranon Fracture
- What is being tested?
- Open reduction and plate osteosynthesis and Conservative treatment with early mobilisation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSwitzerland
- Study dates
- 3 Feb 2026to 3 Feb 2030
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients with an acute (< 2 weeks) Mayo type 2A or 2B olecranon fracture
- Patients aged > 65 years • Patients with reduced functional demand, with a score > 2 and < 7 on the Clinical Frailty Scale
- Patients able to provide informed consent and follow all study procedures as indicated in the protocol
- Signed informed consent for study participation
Who cannot join
- Patients aged < 65 years or with a Clinical Frailty Scale score > 7 or < 2
- Patients with a Mayo type 2A or 2B fracture seen more than 2 weeks after injury
- Old fracture (> 6 months), pseudoarthrosis, or unhealed nerve injury of the ipsilateral upper limb
- Open (Gustilo-Anderson type 2 or 3) or pathological fracture
- Previous injury to, or other condition of, the elbow with severe functional impairment
- Patients with severe comorbidities preventing safe surgical treatment
Show all 9Show fewer
- Other acute fracture or nerve damage of the ipsilateral upper limb
- Known drug or alcohol abuse
- Inability to follow study procedures (e.g., due to language barriers or severe comorbidities)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
EOC - Orthopaedics and Traumatology Service
Lugano, 6900
Christian Candrian, Prof.Dr.med, +41 (0) 91 811 61 23, christian.candrian@eoc.ch
About this study
Official title: Treatment of Olecranon Fractures in the Elderly, a Randomised Controlled Trial Comparing Surgical and Conservative Treatment
This study takes place in one hospital and uses a random method to divide patients into groups. It looks at the best way to treat a broken elbow (specifically, a displaced olecranon fracture) in older adults who don't use their arms heavily. There are 84 patients in total, with 42 people in each group
- Conditions
- Olecranon Fracture
- Being tested
- Open reduction and plate osteosynthesis, Conservative treatment with early mobilisation
- Medical subject headings
- Olecranon Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open reduction and plate osteosynthesisProcedure or surgery
A cut is made along the back of the elbow to reach the broken bone. The surgeon carefully moves tissues aside and protects nearby nerves.
The broken bone is cleaned, realigned, and held in place with a special metal plate and screws. This helps support the bone, especially in older patients with fragile bones. The surgeon checks the placement using live X-ray and moves the arm to ensure stability.
The area is then closed with stitches, bandaged, and sometimes supported with a light splint. Recovery starts early, with gentle exercises to regain movement while protecting the repair.
Conservative treatment with early mobilisationOther
Conservativel treatment usually involves wearing a sling or light support for about two weeks to manage pain. After that, the patient begins gentle, supervised arm movements to prevent stiffness and muscle loss. As the pain improves, exercises become more active and focused on regaining strength. The goal is to let the bone heal while keeping the elbow working well.
| Study group | Role | What they receive |
|---|---|---|
| surgery | Experimental | Open reduction and plate osteosynthesis. The surgical treatment will be performed with a direct approach to the olecranon using a locking compression plate. Receives: Procedure: Open reduction and plate osteosynthesis |
| rehabilitation | Other | Standard rehabilitation with optional upper arm sling for comfort for 2 weeks and progressive mobilization protocol Receives: Other: Conservative treatment with early mobilisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
between-group difference in the Oxford Elbow Score (Italian Version) with the subscales Function, Pain, and Social-Psychological
the Oxford Elbow Score is a patient-reported outcome measure specifically developed to evaluate elbow function. It includes 12 items divided into three domains: elbow pain, elbow function, and social-psychological impact. Each item is scored on a 5-point scale, and domain scores can be summed to obtain an overall score, where higher values indicate better outcomes. It is validated for use in both clinical and research settings and is sensitive to change, making it suitable for assessing treatment effects in patients with elbow disorders
Measured: 6 months after injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start3 Feb 2026
- Primary completion3 Feb 2030 (estimated)
- Study completion3 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ente Ospedaliero Cantonale, Bellinzona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Davide Previtali, MD, Principal investigator, EOC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400692
- Sponsor's protocol ID
- ORL-ORT-049
- Status last verified
- Sep 2026
- First submitted
- 3 Feb 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Olecranon Fractures in the Elderly, a Randomised Controlled Trial Comparing Surgical and Conservative Treatment
- ClinicalTrials.gov ID
- NCT07400692
- Acronym / sponsor ID
- ORL-ORT-049
- Conditions
- Olecranon Fracture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Ente Ospedaliero Cantonale, BellinzonaUniversity, hospital or other
- Study start
- 3 Feb 2026 (actual)
- Primary completion
- 3 Feb 2030 (estimated)
- Study completion
- 3 Feb 2030 (estimated)
- First posted
- 10 Feb 2026 (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 takes place in one hospital and uses a random method to divide patients into groups. It looks at the best way to treat a broken elbow (specifically, a displaced olecranon fracture) in older adults who don't use their arms heavily. There are 84 patients in total, with 42 people in each group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgery | Experimental | Procedure: Open reduction and plate osteosynthesisOpen reduction and plate osteosynthesis. The surgical treatment will be performed with a direct approach to the olecranon using a locking compression plate. |
| rehabilitation | Other | Other: Conservative treatment with early mobilisationStandard rehabilitation with optional upper arm sling for comfort for 2 weeks and progressive mobilization protocol |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients with an acute (< 2 weeks) Mayo type 2A or 2B olecranon fracture
- Patients aged > 65 years • Patients with reduced functional demand, with a score > 2 and < 7 on the Clinical Frailty Scale
- Patients able to provide informed consent and follow all study procedures as indicated in the protocol
- Signed informed consent for study participation
Key exclusion criteria (9 listed)
- Patients aged < 65 years or with a Clinical Frailty Scale score > 7 or < 2
- Patients with a Mayo type 2A or 2B fracture seen more than 2 weeks after injury
- Old fracture (> 6 months), pseudoarthrosis, or unhealed nerve injury of the ipsilateral upper limb
- Open (Gustilo-Anderson type 2 or 3) or pathological fracture
- Previous injury to, or other condition of, the elbow with severe 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 |
|---|---|---|
| Open reduction and plate osteosynthesisA cut is made along the back of the elbow to reach the broken bone. The surgeon carefully moves tissues aside and protects nearby nerves. The broken bone is cleaned, realigned, and held in place with a special metal plate and screws. This helps support the bone, especially in older patients with fragile bones. The surgeon checks the placement using live X-ray and moves the arm to ensure stability. The area is then closed with stitches, bandaged, and sometimes supported with a light splint. Recovery starts early, with gentle exercises to regain movement while protecting the repair. | Procedure or surgery | surgery |
| Conservative treatment with early mobilisationConservativel treatment usually involves wearing a sling or light support for about two weeks to manage pain. After that, the patient begins gentle, supervised arm movements to prevent stiffness and muscle loss. As the pain improves, exercises become more active and focused on regaining strength. The goal is to let the bone heal while keeping the elbow working well. | Other | rehabilitation |
Primary outcome
between-group difference in the Oxford Elbow Score (Italian Version) with the subscales Function, Pain, and Social-Psychological
Time frame: 6 months after injury
the Oxford Elbow Score is a patient-reported outcome measure specifically developed to evaluate elbow function. It includes 12 items divided into three domains: elbow pain, elbow function, and social-psychological impact. Each item is scored on a 5-point scale, and domain scores can be summed to obtain an overall score, where higher values indicate better outcomes. It is validated for use in both clinical and research settings and is sensitive to change, making it suitable for assessing treatment effects in patients with elbow disorders
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 9 Sep 2026.
Related trials for Olecranon Fracture
Active, not recruiting
Treatment of Olecranon Fractures in the Elderly
Olecranon Fracture
Recruiting
The With Or Without Olecranon K-wires Trial
Olecranon Fracture
RecruitingObservational study
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
Not yet recruitingPhase 4
Clinical Trial to Evaluate Three Systems of Osteosynthesis for Fixation of Olecranon Osteotomies in Adults
Olecranon Fracture
Recruiting
Scandinavian Olecranon Research in the Elderly
Olecranon 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.
Davide Previtali, MD principal investigator
EOC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open reduction and plate osteosynthesis and Conservative treatment with early mobilisation in people with Olecranon Fracture, run by Ente Ospedaliero Cantonale, Bellinzona at 1 site in Switzerland.
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 4 inclusion and 9 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 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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 Davide Previtali, MD (0041918117029, RicercaOrtopedia.ORL@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
between-group difference in the Oxford Elbow Score (Italian Version) with the subscales Function, Pain, and Social-Psychological (time frame: 6 months after injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2026; AzTrials last refreshed its copy on 27 Oct 2026.