Osteoporotic Fracture, Sacral Fracture
Conditions
Keywords
sacroplasty, Sacral insufficiency fracture, Pelvic fragility fracture, Minimally invasive, Pain management, Functional recovery
Brief 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.
Interventions
PROCEDUREPercutaneous 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.
OTHERStandard conservative management
Standard non-surgical management including analgesia, mobilisation and physiotherapy according to local clinical practice.
Sponsors
Hull University Teaching Hospitals NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label study. Blinding is not feasible due to the invasive nature of sacroplasty.
Intervention model description
Participants will be assigned to one of two arms: sacroplasty under local anesthetic or standard non-surgical management. Outcomes will be measured at 2 weeks, 6 weeks, 3 months and 6 months.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in health-related quality of life measured using the EQ-5D-5L index score | Baseline, 2 weeks, 6 weeks, 3 months, 6 months | Health-related quality of life measured using the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) index score. The EQ-5D-5L assesses five domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The index score typically ranges from values below 0 (health states worse than death) to 1 (perfect health), with higher scores indicating better health-related quality of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain intensity measured using a Visual Analogue Scale (VAS) score | Baseline, 2 weeks, 6 weeks, 3 months, 6 months | Pain intensity measured using a Visual Analogue Scale (VAS). The VAS is a 0 to 10 scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain severity. The outcome is the change in pain score from baseline at follow-up assessments. |
| Change in mobility measured using the EQ-5D mobility dimension | Baseline, 2 weeks, 6 weeks, 3 months, 6 months | Functional mobility assessed using the mobility dimension of the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) questionnaire. This dimension is scored on a 5-level scale ranging from no problems with mobility to extreme problems with mobility. Higher levels indicate worse mobility. |
| Length of Hospital Stay | Length of stay for index hospitalisation, measured from admission to discharge, with follow-up limited to 6 months. | Duration of hospitalisation measured as the number of days from admission to discharge during the index hospital stay. |
| Number of participants readmitted to hospital | Within 6 months after discharge | Number of participants readmitted to hospital for any cause following discharge from hospital. |
| Procedural Complications | Within 30 days after the procedure | Number of participants experiencing procedural complications related to the intervention, including cement leakage, infection, and deep vein thrombosis. |
| All-Cause Mortality | 30 days, 90 days and 12 months after randomization | Number of participants who die from any cause during follow-up |
Countries
United Kingdom
Contacts
CONTACTResearch Coordinator
Outcome results
None listed