An interventional study of Percutaneous Sacroplasty and Standard conservative management in Sacral Fracture and Osteoporotic Fracture, sponsored by Hull University Teaching Hospitals NHS Trust. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Hull University Teaching Hospitals NHS Trust · Not applicable, Interventional, and Treatment
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.
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.
87 studies on the registry are indexed under Osteoporotic Fractures; 22 are open to participants now.
This study's planned enrollment of 110 is close to the median of 120 across 49 interventional studies indexed under Osteoporotic Fractures.
Browse Osteoporotic Fractures studies →Hull University Teaching Hospitals NHS Trust is the lead sponsor of 95 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 up at 2 weeks, 6 weeks, 3 months and 6 months to assess pain, mobility, quality of life, healthcare use, and safety outcomes.
Procedure: Percutaneous Sacroplasty
Participants in this arm will receive non-surgical management, including analgesia, mobilization, and physiotherapy according to local protocols. Participants will be followed up at 2 weeks, 6 weeks, 3 months and 6 months to assess pain, mobility, quality of life, healthcare use, and safety outcomes.
Other: Standard conservative management
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.
Also known as: Sacral cement augmentation, Sacral vertebroplasty
Standard non-surgical management including analgesia, mobilisation and physiotherapy according to local clinical practice.
Change in health-related quality of life measured using the EQ-5D-5L index score
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.
Time frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months
Change in pain intensity measured using a Visual Analogue Scale (VAS) score
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.
Time frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months
Change in mobility measured using the EQ-5D mobility dimension
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.
Time frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months
Length of Hospital Stay
Duration of hospitalisation measured as the number of days from admission to discharge during the index hospital stay.
Time frame: Length of stay for index hospitalisation, measured from admission to discharge, with follow-up limited to 6 months.
Number of participants readmitted to hospital
Number of participants readmitted to hospital for any cause following discharge from hospital.
Time frame: Within 6 months after discharge
Procedural Complications
Number of participants experiencing procedural complications related to the intervention, including cement leakage, infection, and deep vein thrombosis.
Time frame: Within 30 days after the procedure
All-Cause Mortality
Number of participants who die from any cause during follow-up
Time frame: 30 days, 90 days and 12 months after randomization
Plan to share: Yes — De-identified participant-level data for all trial participants, including demographics, baseline characteristics, clinical outcomes (pain scores, mobility measures, quality of life) and relevant safety data. No personally identifying information (names, dates of birth, addresses) will be included. Data will be shared for research purposes only, consistent with ethical approvals and informed consent.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Start date: 6 months after publication of the main trial results. End date: 5 years after publication.
Access criteria: Access to de-identified participant-level data and supporting information will be available to qualified researchers for legitimate scientific research purposes. Researchers will need to submit a request and agree to a data use agreement to protect confidentiality and prevent re-identification. The study team will provide secure access to approved requests.
Start is estimated for Jan 2027; primary completion for Dec 2029, 35 months later.
Of 22 interventional studies with no phase under Osteoporotic Fractures, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 60. This study's planned 35 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Hull University Teaching Hospitals NHS Trust