Sacroplasty for Sacral Insufficiency Fractures.

NCT07493564 | Not Yet Recruiting

• 1 other identifier: SACRA
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Sacral Fracture; Osteoporotic Fracture

Keywords

sacroplasty; Sacral insufficiency fracture; Pelvic fragility fracture; Minimally invasive; Pain management; Functional recovery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in pain intensity measured using a Visual Analogue Scale (VAS) score

  Baseline, 6 weeks, 6 months

• Change in mobility measured using the EQ-5D mobility dimension

  Baseline, 6 weeks, 6 months

• Length of 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

  Within 6 months after discharge

• Procedural Complications

  Within 30 days after the procedure

Study Arms (2)

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 for 6 weeks and 6 months to assess pain, mobility, quality of life, healthcare use, and safety outcomes.

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 for 6 weeks and 6 months to assess pain, mobility, quality of life, healthcare use, and safety outcomes.

Other: Standard conservative management

Interventions

Percutaneous Sacroplasty PROCEDURE

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

Sacroplasty

Standard conservative management OTHER

Standard non-surgical management including analgesia, mobilisation and physiotherapy according to local clinical practice.

Standard conservative management

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead

Study Sites (1)

Hull University Teaching Hospitals

Hull, East Yorkshire, HU3 2JZ, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 38398383 BACKGROUND

• 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.

  PMID: 31296516 BACKGROUND

• 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.

  PMID: 29124468 BACKGROUND

• 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.

  PMID: 37575865 BACKGROUND

MeSH Terms

Conditions

Osteoporotic Fractures; Agnosia

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Research Coordinator

CONTACT

01482315506; hyp-tr.orthopaedic.research@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. Blinding is not feasible due to the invasive nature of sacroplasty.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Participants will be assigned to one of two arms: sacroplasty under local anesthetic or standard non-surgical management. Outcomes will be measured at 6 weeks and 6 months.

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 25, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, 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.

Locations

GB (1)