Sacroplasty for Sacral Insufficiency Fractures.

Official title

Sacroplasty for Sacral Insufficiency Fractures: a Randomised Controlled Trial.

Overview

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.

Interventions

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

Primary outcome measures

• Change in health-related quality of life measured using the EQ-5D-5L index score [Time frame: Baseline, 6 weeks, 6 months]

Secondary outcome measures (6)

• Change in pain intensity measured using a Visual Analogue Scale (VAS) score [Time frame: Baseline, 6 weeks, 6 months]
• Change in mobility measured using the EQ-5D mobility dimension [Time frame: Baseline, 6 weeks, 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United Kingdom · 1 center

• Hull University Teaching Hospitals — Hull

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. PMID 38398383
• 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
• 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
• 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

Identifiers

NCT: NCT07493564 · SACRA

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗