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NCT07493564
Sacroplasty for Sacral Insufficiency Fractures.
Conditions: Sacral Fracture, Osteoporotic Fracture
Sex: All
Ages: 50 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 110
Sponsor: Hull University Teaching Hospitals NHS Trust
Location: Hull University Teaching Hospitals Hull East Yorkshire
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.
Eligibility Criteria
Inclusion Criteria:
* Age 50 years or older
* Low-energy sacral or posterior pelvic fracture confirmed on CT
* Symptom duration ≤6 weeks with ongoing pain ≥48 hours
* Suitable for sacroplasty under local anesthetic with optional sedation
* Informed consent
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 \
Source: ClinicalTrials.gov (NCT07493564). StuddyBuddy aggregates publicly available trial information.