Olecranon FracturePhase 4NCT07014358
Clinical Trial to Evaluate Three Systems of Osteosynthesis for Fixation of Olecranon Osteotomies in Adults
A Phase 4 study testing Fastening systems by placing two steel pins, Fastening systems by a wire in an obenque configuration and Fastening systems by the placement of a bolted plate or the placement of a compression screw in people with Olecranon Fracture, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 5 sites in Spain.
Trial summary
Surgery of the elbow joint is often made difficult by the highly constrained nature of the elbow joint. This is why it is often necessary to perform an osteotomy of the olecranon, the proximal part of the ulna, which allows perfect exposure of the entire articular surface. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Olecranon Fracture
- What is being tested?
- Fastening systems by placing two steel pins, Fastening systems by a wire in an obenque configuration and Fastening systems by the placement of a bolted plate or the placement of a compression screw
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 5 sitesSpain
- Study dates
- Jun 2025to Jun 2027
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who, after receiving information about the design, the purposes of the study, the possible risks that may arise from it and the fact that they may refuse to collaborate at any time, give their written consent to participate in the study.
- Be over 18 years of ag
- Have an elbow disorder that is to be treated surgically through an olecranon osteotomy approach.
- That the olecranon osteotomy is amenable to synthesization with the three proposed systems.
- Understand the purpose of the study and be available for routine hospital visits.
Who cannot join
- Patients who have undergone ipsilateral elbow surgery.
- Presence of ulnar fractures
- Patients with an active infection at any site at the time of elbow surgery.
- Inability to understand the procedure or information related to the study.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Spain5 sites
Clínica CEMTRO
Madrid, Madrid, 28035
Ignacio De Rus Aznar, iderus@hotmail.com
Hospital Universitario de Móstoles
Madrid, 28935
Gia Rodríguez Vaquero, gia.rodriguez@quironsalud.es
Hospital Mutua Montañesa Santander
Santander, Cantabria, 39012
Hospital de Manises
Valencia, Manises, 46940
Pablo Cañete Pastor
Hospital La Fe
Valencia, Valencia, 46026
Marta Navarro Bosch, mnavarrob26@yahoo.es
About this study
Official title: Randomized, Patient-blinded, Evaluator-blinded Clinical Trial With Three CE-marked and Approved Devices
Surgery of the elbow joint is often made difficult by the highly constrained nature of the elbow joint. This is why it is often necessary to perform an osteotomy of the olecranon, the proximal part of the ulna, which allows perfect exposure of the entire articular surface. After performing the osteotomy, access to the joint is obtained, the articular problem is solved as appropriate and, upon completion, the osteotomized bone is fixed with a stable fixation system that allows the osteotomy to heal without problems. It is a safe, reproducible procedure that is associated with low associated morbidity. The main problems associated with this procedure are the lack of consolidation of the osteotomy or the need for removal of the osteosynthesis material at a later stage.
Read the detailed description
The incidence of these complications is around 4% for the former and 20-50% for the latter. Both complications usually require a second surgical procedure to solve the problem, so the reoperation rates for these procedures are around 40-50%.
However, there is discussion in the literature as to the most appropriate fixation system to ensure fracture healing. There are, broadly speaking, three frequently used fixation systems: the placement of two steel pins and a wire in an obenque configuration, the placement of a screwed plate or the placement of a compression screw.
It is not clear which is the best fixation system among these three. Biomechanical studies suggest that, from this point of view, all three procedures are adequate. The choice of which is ideal should therefore be based on the ease of use and the complications associated with the procedure, in particular the reoperation rate.There are no clinical trials in the literature comparing these three fixation techniques, so there is a clear lack of knowledge in this field.
- Conditions
- Olecranon Fracture
- Being tested
- Fastening systems by placing two steel pins, Fastening systems by a wire in an obenque configuration, Fastening systems by the placement of a bolted plate or the placement of a compression screw
- Medical subject headings
- Olecranon Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fastening systems by placing two steel pinsDevice
Fixation of the osteotomized bone with a stable fixation system, in this case, the placement of two steel pins.
Fastening systems by a wire in an obenque configurationDevice
Fixation of the osteotomized bone with a stable fixation system, in this case, an obenque configuration
Fastening systems by the placement of a bolted plate or the placement of a compression screwDevice
Fixation of the osteotomized bone with a stable fixation system, in this case, the placement of a bolted plate or the placement of a compression screw.
| Study group | Role | What they receive |
|---|---|---|
| Fastening systems by placing two steel pins | Experimental | Fixation of the osteotomized bone with a stable fixation system, in this case, the placement of two steel pins. Receives: Device: Fastening systems by placing two steel pins |
| Fastening systems by a wire in an obenque configuration | Experimental | Fixation of the osteotomized bone with a stable fixation system, in this case, an obenque configuration. Receives: Device: Fastening systems by a wire in an obenque configuration |
| Fastening systems by the placement of a bolted plate or the placement of a compression screw | Experimental | Fixation of the osteotomized bone with a stable fixation system, in this case, the placement of a bolted plate or the placement of a compression screw. Receives: Device: Fastening systems by the placement of a bolted plate or the placement of a compression screw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Define which of the three fixarion systems is safer based on the number of patients with each fixation system that need to be reintervened.
The main evaluation criterion will be the need for reoperation for any cause related to the olecranon osteotomy in the first year of follow-up.
Measured: 12 Months
Secondary outcomes (9)
Number of patients suffering Adverse Events related or not with the medical product within a year
Infection
Measured: 12 months
Number of patients suffering Adverse Events related or not with the medical product within a year
Complications in the healing process of the surgical wound
Measured: 12 months
Number of patients suffering: Adverse Events related or not with the medical product within a year
Mechanical complications with the implant
Measured: 12 months
Number of patients suffering Adverse Events related or not with the medical product, within a year
Reintervention
Measured: 12 months
Number of patients suffering Adverse Events, related or not with the medical product, within a year
Residual pain
Measured: 12 months
Number of patients suffering Adverse Events related or not, with the medical product, within a year
Fracture
Measured: 12 months
Efficacy measured usimg the evaluation of different scales and tests performed by the patient, that altogether provide the needed information about the efficacy of the medical product.
Measured by Pain leveld (BPI test)
Measured: 24 months
Efficacy, measured usimg the evaluation of different scales and tests performed by the patient that altogether provide the needed information about the efficacy of the medical product.
Measured by Mayo Elbow Score Scale (MEPS)
Measured: 24 months
Efficacy, measured usimg the evaluation of different scales and tests performed by the patient, that altogether provide the needed information about the efficacy of the medical product
Measured by pasive and active movility range
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study startJun 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2027 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07014358
- Sponsor's protocol ID
- FIJAOLE01
- Status last verified
- Jun 2025
- First submitted
- 13 May 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Patient-blinded, Evaluator-blinded Clinical Trial With Three CE-marked and Approved Devices
- ClinicalTrials.gov ID
- NCT07014358
- Acronym / sponsor ID
- FIJAOLE01
- Conditions
- Olecranon Fracture
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 11 Jun 2025 (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.
Surgery of the elbow joint is often made difficult by the highly constrained nature of the elbow joint. This is why it is often necessary to perform an osteotomy of the olecranon, the proximal part of the ulna, which allows perfect exposure of the entire articular surface. After performing the osteotomy, access to the joint is obtained, the articular problem is solved as appropriate and, upon completion, the osteotomized bone is fixed with a stable fixation system that allows the osteotomy to heal without problems. It is a safe, reproducible procedure that is associated with low associated morbidity. The main problems associated with this procedure are the lack of consolidation of the osteotomy or the need for removal of the osteosynthesis material at a later stage.
Detailed description
The incidence of these complications is around 4% for the former and 20-50% for the latter. Both complications usually require a second surgical procedure to solve the problem, so the reoperation rates for these procedures are around 40-50%.
However, there is discussion in the literature as to the most appropriate fixation system to ensure fracture healing. There are, broadly speaking, three frequently used fixation systems: the placement of two steel pins and a wire in an obenque configuration, the placement of a screwed plate or the placement of a compression screw.
It is not clear which is the best fixation system among these three. Biomechanical studies suggest that, from this point of view, all three procedures are adequate. The choice of which is ideal should therefore be based on the ease of use and the complications associated with the procedure, in particular the reoperation rate.There are no clinical trials in the literature comparing these three fixation techniques, so there is a clear lack of knowledge in this field.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fastening systems by placing two steel pins | Experimental | Device: Fastening systems by placing two steel pinsFixation of the osteotomized bone with a stable fixation system, in this case, the placement of two steel pins. |
| Fastening systems by a wire in an obenque configuration | Experimental | Device: Fastening systems by a wire in an obenque configurationFixation of the osteotomized bone with a stable fixation system, in this case, an obenque configuration. |
| Fastening systems by the placement of a bolted plate or the placement of a compression screw | Experimental | Device: Fastening systems by the placement of a bolted plate or the placement of a compression screwFixation of the osteotomized bone with a stable fixation system, in this case, the placement of a bolted plate or the placement of a compression screw. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who, after receiving information about the design, the purposes of the study, the possible risks that may arise from it and the fact that they may refuse to collaborate at any time, give their written consent to participate in the study.
- Be over 18 years of ag
- Have an elbow disorder that is to be treated surgically through an olecranon osteotomy approach.
- That the olecranon osteotomy is amenable to synthesization with the three proposed systems.
- Understand the purpose of the study and be available for routine hospital visits.
Key exclusion criteria (4 listed)
- Patients who have undergone ipsilateral elbow surgery.
- Presence of ulnar fractures
- Patients with an active infection at any site at the time of elbow surgery.
- Inability to understand the procedure or information related to the study.
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 |
|---|---|---|
| Fastening systems by placing two steel pinsFixation of the osteotomized bone with a stable fixation system, in this case, the placement of two steel pins. | Device | Fastening systems by placing two steel pins |
| Fastening systems by a wire in an obenque configurationFixation of the osteotomized bone with a stable fixation system, in this case, an obenque configuration | Device | Fastening systems by a wire in an obenque configuration |
| Fastening systems by the placement of a bolted plate or the placement of a compression screwFixation of the osteotomized bone with a stable fixation system, in this case, the placement of a bolted plate or the placement of a compression screw. | Device | Fastening systems by the placement of a bolted plate or the placement of a compression screw |
Primary outcome
Define which of the three fixarion systems is safer based on the number of patients with each fixation system that need to be reintervened.
Time frame: 12 Months
The main evaluation criterion will be the need for reoperation for any cause related to the olecranon osteotomy in the first year of follow-up.
9 secondary outcomes
Number of patients suffering Adverse Events related or not with the medical product within a year
Time frame: 12 months
Number of patients suffering Adverse Events related or not with the medical product within a year
Time frame: 12 months
Number of patients suffering: Adverse Events related or not with the medical product within a year
Time frame: 12 months
Number of patients suffering Adverse Events related or not with the medical product, within a year
Time frame: 12 months
Number of patients suffering Adverse Events, related or not with the medical product, within a year
Time frame: 12 months
Number of patients suffering Adverse Events related or not, with the medical product, within a year
Time frame: 12 months
Efficacy measured usimg the evaluation of different scales and tests performed by the patient, that altogether provide the needed information about the efficacy of the medical product.
Time frame: 24 months
Efficacy, measured usimg the evaluation of different scales and tests performed by the patient that altogether provide the needed information about the efficacy of the medical product.
Time frame: 24 months
Efficacy, measured usimg the evaluation of different scales and tests performed by the patient, that altogether provide the needed information about the efficacy of the medical product
Time frame: 24 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 11 Jun 2025.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fastening systems by placing two steel pins, Fastening systems by a wire in an obenque configuration and Fastening systems by the placement of a bolted plate or the placement of a compression screw in people with Olecranon Fracture, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 5 sites in Spain.
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 5 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: opening soon, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Miguel Ruiz Ibán, Md (913368208, drmri@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Define which of the three fixarion systems is safer based on the number of patients with each fixation system that need to be reintervened. (time frame: 12 Months). 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 11 Jun 2025.