NCT07493564

Sacroplasty for Sacral Insufficiency Fractures.

Sacroplasty for Sacral Insufficiency Fractures: a Randomised Controlled Trial.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Hull University Teaching Hospitals NHS Trust · Other Government
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Sacral insufficiency fractures are common in the elderly population. These fractures are typically managed with conservative management, including analgesia, physiotherapy and mobilisation. However, conservative treatment is often complicated by prolonged pain, immobility, prolonged hospitalisation and loss of independence. There is also a high risk of medical complications associated with deconditioning, such as atelectasis, pneumonia, pressure sores and venous thromboembolism. The mortality rate after sacral insufficiency fractures is up to 17.5% at 1 year and 25.5% at 3 years. Sacroplasty, a minimally invasive percutaneous cement augmentation procedure for sacral fractures, may offer rapid pain relief and earlier mobilisation. Some studies have shown an improvement in pain scores and early return to mobility following sacroplasty but larger, higher quality studies are needed. This study investigates the effectiveness of sacroplasty, a minimally invasive percutaneous cement augmentation procedure, in improving outcomes for patients with sacral insufficiency fractures. This study is an open-label, parallel-group randomised controlled trial designed to compare sacroplasty with standard conservative management. The intervention will be performed under local anaesthesia with optional conscious sedation, in contrast to the ASSERT trial which performed sacroplasty under general anaesthesia. This approach has been chosen to improve feasibility and recruitment by enabling inclusion of a broader and potentially frailer patient population who may not be suitable for general anaesthesia, The primary objective is to determine whether sacroplasty improves health-related quality of life and functional recovery compared with standard care. Secondary objectives include evaluation of pain, mobility, healthcare utilisation and safety outcomes. The findings of this study are expected to provide important evidence to inform clinical practice and improve the management of sacral insufficiency fractures in older adults.

Conditions

• Sacral Fracture
• Osteoporotic Fracture

Interventions

Type	Name	Description
PROCEDURE	Percutaneous Sacroplasty	Percutaneous image-guided cement augmentation of sacral fractures performed under local anesthetic with optional conscious sedation. The procedure is performed by an interventional radiologist with the aim of reducing pain.
OTHER	Standard conservative management	Standard non-surgical management including analgesia, mobilisation and physiotherapy according to local clinical practice.

Timeline

• Start date: 2027-01-01
• Primary completion: 2029-12-01
• Completion: 2030-12-01
• First posted: 2026-03-25
• Last updated: 2026-03-25

Locations

1 site across 1 country: United Kingdom