Sacroplasty for Sacral Insufficiency Fractures. (SACRA)

NHS Trust

Status: Begins enrollment in 7 months

Conditions: Osteoporotic Fracture; Sacral Fracture

Treatments: Other: Standard conservative management; Procedure: Percutaneous Sacroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT07493564

SACRA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 2 patient groups

Sacroplasty

Experimental group

Description:

Participants in this arm will undergo percutaneous sacroplasty under local anesthesia, with optional conscious sedation. The procedure will be performed by interventional radiologists to stabilize sacral or posterior pelvic fragility fractures. Participants will be followed for 6 weeks and 6 months to assess pain, mobility, quality of life, healthcare use, and safety outcomes.

Treatment:

Procedure: Percutaneous Sacroplasty

Standard conservative management

Active Comparator group

Description:

Participants in this arm will receive non-surgical management, including analgesia, mobilization, and physiotherapy according to local protocols. Participants will be followed for 6 weeks and 6 months to assess pain, mobility, quality of life, healthcare use, and safety outcomes.

Treatment:

Other: Standard conservative management