Sacroplasty for Sacral Insufficiency Fractures.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorHull University Teaching Hospitals NHS Trust
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Percutaneous Sacroplasty
Procedure/SurgeryPercutaneous 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 management
Other interventionStandard non-surgical management including analgesia, mobilisation and physiotherapy according to local clinical practice.
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: SacroplastyExperimental treatment 1 intervention
Group B: Standard conservative managementActive comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline, 2 weeks, 6 weeks, 3 months, 6 monthsSecondary outcomes
1
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.
Time frame
Baseline, 2 weeks, 6 weeks, 3 months, 6 months2
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.
Time frame
Baseline, 2 weeks, 6 weeks, 3 months, 6 months3
Length of Hospital Stay
Duration of hospitalisation measured as the number of days from admission to discharge during the index hospital stay.
Time frame
Length of stay for index hospitalisation, measured from admission to discharge, with follow-up limited to 6 months.4
Number of participants readmitted to hospital
Number of participants readmitted to hospital for any cause following discharge from hospital.
Time frame
Within 6 months after dischargeSponsors and contacts
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Source ClinicalTrials.gov
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