Comparison of Minimally Invasive Versus Open Spinopelvic Fixation for Unstable Sacral Fractures (NCT06755580) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Minimally Invasive Versus Open Spinopelvic Fixation for Unstable Sacral Fractures
Slovakia51 participantsStarted 2014-01-01
Plain-language summary
The aim of this retrospective study is to evaluate patients with vertically unstable high-energy sacral fracture operated on at our institution with spinopelvic fixation, to compare the traditionally open method of fixation with the minimally invasive fixation. The aim of the research is to determine whether minimally invasive surgical techniques can achieve comparable fracture reduction and functional outcome as open surgical approaches. Another aim is to determine whether the minimally invasive surgical procedure leads to shorter patient hospitalization, lower perioperative blood loss, and lower postoperative complications.
Who can participate
Age range
16 Years – 77 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:
* patient with high energy vertically unstable sacral fracture
* patients operated with open or minimally invasive spinopelvic fixation
* patients followed up for at least one year
Exclusion Criteria:
* patients with low-energy osteoporotic fractures of the sacrum
* patients with insufficiency fractures of the sacrum
* patients operated on using a method other than spinopelvic fixation
* patients who were not followed up for at least one year after surgery
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
pelvic ring symmetry
Timeframe: up to 1 year
2
invasiveness of the surgical procedure
Timeframe: in perioperative period
3
length of the surgical procedure
Timeframe: in perioperative period
4
radiation exposure of the patient during surgical procedure
Timeframe: in perioperative period
5
Functional outcome after surgery based on a standardized questionnaire according to the Majeed score
Timeframe: one year after surgery
6
complications
Timeframe: 1 year
Trial details
NCT IDNCT06755580
SponsorF.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica