NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Sponsor: Hull University Teaching Hospitals NHS Trust
Conditions: Sacral Fracture, Osteoporotic Fracture
Interventions: Percutaneous Sacroplasty, Standard conservative management
Countries: United Kingdom
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.
Sex: ALL
Age: 50 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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 \<3 months * Participation in conflicting interventional trial * Previous sacroplasty * Patient not suitable for sacroplasty under local anesthetic with optional sedation
- Hull, East Yorkshire, United Kingdom