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NOT YET RECRUITING
NCT07493564
NA

Sacroplasty for Sacral Insufficiency Fractures.

Sponsor: Hull University Teaching Hospitals NHS Trust

View on ClinicalTrials.gov

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.

Official title: Sacroplasty for Sacral Insufficiency Fractures: a Randomised Controlled Trial.

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

78

Start Date

2027-01

Completion Date

2030-12

Last Updated

2026-03-25

Healthy Volunteers

No

Interventions

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.

Locations (1)

Hull University Teaching Hospitals

Hull, East Yorkshire, United Kingdom