Sacroplasty for Sacral Insufficiency Fractures. (SACRA)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Osteoporotic Fracture; Sacral Fracture
• Intervention / Treatment: Procedure: Percutaneous Sacroplasty; Other: Standard conservative management

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 Type: Interventional
• Enrollment (Estimated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Research Coordinator; Phone Number: 01482315506; Email: hyp-tr.orthopaedic.research@nhs.net

Study Locations

• United Kingdom
  • East Yorkshire
    • Hull, East Yorkshire, United Kingdom, HU3 2JZ
      • Hull University Teaching Hospitals
      • Contact: Research Coordinator; Phone Number: 01482315506; Email: mukai.c-gordon@nhs.net
      • Principal Investigator: Mukai Chimutengwende-Gordon, PhD,FRCS
      • Sub-Investigator: Hemant Sharma, MCh, FRCS
      • Sub-Investigator: Paul Maliakal, FRCR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sacroplasty; 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.	Procedure: 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.; Other Names: Sacral cement augmentation; Sacral vertebroplasty
Active Comparator: Standard 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.	Other: Standard conservative management; Standard non-surgical management including analgesia, mobilisation and physiotherapy according to local clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time 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 Measure	Measure Description	Time 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

Collaborators and Investigators

• Sponsor: Hull University Teaching Hospitals NHS Trust

Publications and helpful links

General 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.
• van 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.
• Park 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.
• Briggs 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.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: March 23, 2026
• First Posted (Actual): March 25, 2026

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Pain management; Functional recovery; Minimally invasive; sacroplasty; Sacral insufficiency fracture; Pelvic fragility fracture
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Wounds and Injuries; Neurobehavioral Manifestations; Fractures, Bone; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia; Osteoporotic Fractures
• Other Study ID Numbers: SACRA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Start date: 6 months after publication of the main trial results. End date: 5 years after publication.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No