Clinical Trial to Evaluate Three Systems of Osteosynthesis for Fixation of Olecranon Osteotomies … (NCT07014358) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Clinical Trial to Evaluate Three Systems of Osteosynthesis for Fixation of Olecranon Osteotomies in Adults
Spain105 participantsStarted 2025-06
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Define which of the three fixarion systems is safer based on the number of patients with each fixation system that need to be reintervened.
Timeframe: 12 Months
Trial details
NCT IDNCT07014358
SponsorFundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal