Sacroplasty for Sacral Insufficiency Fractures. (NCT07493564) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Sacroplasty for Sacral Insufficiency Fractures.
United Kingdom78 participantsStarted 2027-01
Plain-language summary
This study is designed to determine whether sacroplasty, a minimally invasive procedure to stabilize sacral fractures, improves quality of life and functional recovery in adults aged 50 years or older with sacral or posterior pelvic fragility fractures. These fractures are common in older adults and can cause prolonged pain, reduced mobility, and an increased rate of mortality and risk of complications such as pneumonia, blood clots and pressure sores. Standard treatment usually involves pain management, physiotherapy and mobilization but recovery can be slow.
Participants will be randomly assigned to receive either sacroplasty under local anaesthetic (with optional sedation) performed by interventional radiologists or standard non-surgical care including analgesia and physiotherapy. Follow-up assessments will take place at 6 weeks and 6 months to evaluate pain, mobility, healthcare use, safety and overall quality of life.
The goal of the study is to provide evidence on whether sacroplasty can accelerate recovery, reduce complications and improve independence and quality of life in older adults with these fractures.
Who can participate
Age range
50 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:
* Age 50 years or older
* Low-energy sacral or posterior pelvic fracture confirmed on CT or MRI
* Symptom duration ≤6 weeks with ongoing pain ≥48 hours
* Suitable for sacroplasty under local anesthetic with optional sedation
* Informed consent provided by participant or consultee agreement under the Mental Capacity Act 2005
Exclusion Criteria:
* High-energy or unstable pelvic ring fracture requiring open fixation
* Active infection or malignancy at fracture site
* Uncorrectable coagulopathy or anatomy precluding safe sacroplasty
* Life expectancy \<3 months
* Participation in conflicting interventional trial
* Previous sacroplasty
* Patient not suitable for sacroplasty under local anesthetic with optional sedation
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
Change in health-related quality of life measured using the EQ-5D-5L index score
Timeframe: Baseline, 6 weeks, 6 months
Trial details
NCT IDNCT07493564
SponsorHull University Teaching Hospitals NHS Trust