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Clinical Trial NCT07493564 (SACRA) for Sacral Fracture, Osteoporotic Fracture is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Sacroplasty for Sacral Insufficiency Fractures. (SACRA) 78

Not yet recruiting
Clinical Trial NCT07493564 (SACRA) is an interventional study for Sacral Fracture, Osteoporotic Fracture and is currently not yet recruiting. Enrollment is planned to begin on 1 January 2027 and continue until the study accrues 78 participants. Led by Hull University Teaching Hospitals NHS Trust, this study is expected to complete by 1 December 2030. The latest data from ClinicalTrials.gov was last updated on 25 March 2026.
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 pneumo...Show More
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 ate...Show More
Official Title

Sacroplasty for Sacral Insufficiency Fractures: a Randomised Controlled Trial.

Conditions
Sacral FractureOsteoporotic Fracture
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • SACRA
NCT ID Number
NCT07493564
Start Date (Actual)
2027-01
Last Update Posted
2026-03-25
Completion Date (Estimated)
2030-12
Enrollment (Estimated)
78
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
sacroplasty
Sacral insufficiency fracture
Pelvic fragility fracture
Minimally invasive
Pain management
Functional recovery
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalSacroplasty
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.
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.
Active ComparatorStandard conservative management
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.
Standard conservative management
Standard non-surgical management including analgesia, mobilisation and physiotherapy according to local clinical practice.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
Baseline, 6 weeks, 6 months
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
Baseline, 6 weeks, 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.
Baseline, 6 weeks, 6 months
Length of Hospital Stay
Duration of hospitalisation measured as the number of days from admission to discharge during the index hospital stay.
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.
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.
Within 30 days after the procedure
All-Cause Mortality
Number of participants who die from any cause during follow-up
30 days, 90 days and 12 months after randomization
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
50 Years
Eligible Sexes
All
  • 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

  • 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
Hull University Teaching Hospitals NHS Trust logoHull University Teaching Hospitals NHS Trust
Study Central Contact
Contact: Research Coordinator, 01482315506, [email protected]
1 Study Locations in 1 Countries

East Yorkshire

Hull University Teaching Hospitals, Hull, East Yorkshire, HU3 2JZ, United Kingdom
Research Coordinator, Contact, 01482315506, [email protected]
Mukai Chimutengwende-Gordon, PhD,FRCS, Principal Investigator
Hemant Sharma, MCh, FRCS, Sub-Investigator
Paul Maliakal, FRCR, Sub-Investigator