Sacral FractureSACRANCT07493564
Sacroplasty for Sacral Insufficiency Fractures.
A study testing Percutaneous Sacroplasty and Standard conservative management in people with Sacral Fracture and Osteoporotic Fracture, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Sacral Fracture, Osteoporotic Fracture
- What is being tested?
- Percutaneous Sacroplasty and Standard conservative management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2027to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Hull University Teaching Hospitals
Hull, East Yorkshire, HU3 2JZ
Research Coordinator, 01482315506, mukai.c-gordon@nhs.net
Mukai Chimutengwende-Gordon, PhD,FRCS
About this study
Official title: Sacroplasty for Sacral Insufficiency Fractures: a Randomised Controlled Trial.
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.
Read the 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
- Being tested
- Percutaneous Sacroplasty, Standard conservative management
- Keywords
- sacroplasty, Sacral insufficiency fracture, Pelvic fragility fracture, Minimally invasive, Pain management, Functional recovery
- Medical subject headings
- Osteoporotic Fractures, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous SacroplastyProcedure or surgery
Also called Sacral cement augmentation, Sacral vertebroplasty
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.
Standard conservative managementOther
Standard non-surgical management including analgesia, mobilisation and physiotherapy according to local clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Sacroplasty | Experimental | 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. Receives: Procedure: Percutaneous Sacroplasty |
| Standard conservative management | Active comparator | 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. Receives: Other: Standard conservative management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 2 weeks, 6 weeks, 3 months, 6 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 30 days after the procedure
All-Cause Mortality
Number of participants who die from any cause during follow-up
Measured: 30 days, 90 days and 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study startJan 2027 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sacral FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07493564
- Sponsor's protocol ID
- SACRA
- Acronym
- SACRA
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Stolberg-Stolberg J, Lodde MF, Seiss D, Koppe J, Hartensuer R, Raschke MJ, Riesenbeck O. Long-Term Follow-Up after Iliosacral Screw Fixation of Unstable Pelvic Ring Fractures. J Clin Med. 2024 Feb 14;13(4):1070. doi: 10.3390/jcm13041070.
PubMed 38398383van Berkel D, Ong T, Drummond A, Hendrick P, Leighton P, Jones M, Salem K, Quraishi N, Brookes C, Suazo Di Paola A, Edwards S, Sahota O. ASSERT (Acute Sacral inSufficiEncy fractuRe augmenTation) randomised controlled, feasibility in older people trial: a study protocol. BMJ Open. 2019 Jul 10;9(7):e032111. doi: 10.1136/bmjopen-2019-032111.
PubMed 31296516Park JW, Park SM, Lee HJ, Lee CK, Chang BS, Kim H. Mortality following benign sacral insufficiency fracture and associated risk factors. Arch Osteoporos. 2017 Nov 9;12(1):100. doi: 10.1007/s11657-017-0395-3.
PubMed 29124468Briggs P, King SW, Staniland T, Gopal S, Shah R, Chimutengwende-Gordon M. A Systematic Review of Sacral Insufficiency Fractures: Treatment Modalities and Outcomes. Cureus. 2023 Jul 11;15(7):e41745. doi: 10.7759/cureus.41745. eCollection 2023 Jul.
PubMed 37575865
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sacroplasty for Sacral Insufficiency Fractures: a Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT07493564
- Acronym / sponsor ID
- SACRA / SACRA
- Conditions
- Sacral Fracture, Osteoporotic Fracture
- Keywords
- sacroplasty, Sacral insufficiency fracture, Pelvic fragility fracture, Minimally invasive, Pain management, Functional recovery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sacroplasty | Experimental | Procedure: Percutaneous SacroplastyParticipants 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. |
| Standard conservative management | Active comparator | Other: Standard conservative managementParticipants 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous SacroplastyAlso: Sacral cement augmentation, Sacral vertebroplastyPercutaneous 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. | Procedure or surgery | Sacroplasty |
| Standard conservative managementStandard non-surgical management including analgesia, mobilisation and physiotherapy according to local clinical practice. | Other | Standard conservative management |
Primary outcome
Change in health-related quality of life measured using the EQ-5D-5L index score
Time frame: 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.
6 secondary outcomes
Change in pain intensity measured using a Visual Analogue Scale (VAS) score
Time frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months
Change in mobility measured using the EQ-5D mobility dimension
Time frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months
Length of 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
Time frame: Within 6 months after discharge
Procedural Complications
Time frame: Within 30 days after the procedure
All-Cause Mortality
Time frame: 30 days, 90 days and 12 months after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 38398383Stolberg-Stolberg J, Lodde MF, Seiss D, Koppe J, Hartensuer R, Raschke MJ, Riesenbeck O. Long-Term Follow-Up after Iliosacral Screw Fixation of Unstable Pelvic Ring Fractures. J Clin Med. 2024 Feb 14;13(4):1070. doi: 10.3390/jcm13041070.
- Background: PubMed 31296516van Berkel D, Ong T, Drummond A, Hendrick P, Leighton P, Jones M, Salem K, Quraishi N, Brookes C, Suazo Di Paola A, Edwards S, Sahota O. ASSERT (Acute Sacral inSufficiEncy fractuRe augmenTation) randomised controlled, feasibility in older people trial: a study protocol. BMJ Open. 2019 Jul 10;9(7):e032111. doi: 10.1136/bmjopen-2019-032111.
- Background: PubMed 29124468Park JW, Park SM, Lee HJ, Lee CK, Chang BS, Kim H. Mortality following benign sacral insufficiency fracture and associated risk factors. Arch Osteoporos. 2017 Nov 9;12(1):100. doi: 10.1007/s11657-017-0395-3.
- Background: PubMed 37575865Briggs P, King SW, Staniland T, Gopal S, Shah R, Chimutengwende-Gordon M. A Systematic Review of Sacral Insufficiency Fractures: Treatment Modalities and Outcomes. Cureus. 2023 Jul 11;15(7):e41745. doi: 10.7759/cureus.41745. eCollection 2023 Jul.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Sacroplasty and Standard conservative management in people with Sacral Fracture and Osteoporotic Fracture, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Coordinator (01482315506, hyp-tr.orthopaedic.research@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in health-related quality of life measured using the EQ-5D-5L index score (time frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07493564, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.