Thoracolumbar fractures Musculoskeletal Diseases Injuries to the abdomen, lower back, lumbar spine and pelvis
Conditions
Interventions
The trial objectives will be addressed through three elements:
1. A randomised pilot study
2. A national survey of surgeons
3. A qualitative study
Sponsors
South Tees Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 16 years or older 2. Diagnosis of a high- or low-energy impact thoracolumbar vertebral fracture, between T10 and L2, and confirmed by radiograph, computed tomography (CT) scan or magnetic resonance imaging (MRI) with any ONE of the following criteria: 2.1. A kyphotic angle greater than 20 degrees on standing radiographs, or if lying CT or radiograph then 15 degrees of kyphosis or 2.2. Reduction of vertebral body height by 25 percent or 2.3. Fracture line propagating through the posterior wall of vertebra or 2.4. Two contiguous vertebrae involved or 2.5. Injury to the posterior longitudinal ligament (PLL) or annulus in addition to the body fracture
Exclusion criteria
Exclusion criteria: 1. Unstable fractures which obviously need surgical stabilisation – decision made by the treating surgeon 2. Spinal cord injury 3. Pathological (other than osteoporotic) fracture e.g. tumour / infection 4. Patient not considered suitable for surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recruitment rate, defined as the proportion of eligible participants who are randomised during the recruitment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Feasibility is measured using: 1. Recruitment rates as defined as: 1.1. Number of eligible patients 1.2. Proportion of eligible patients approached for consent 1.3. Proportion of eligible patients not approached for consent and reasons why 1.4. Proportion of patients approached who provide consent 1.5. Proportion of patients approached who do not provide consent and reasons why 2. Randomisation: 2.1. Proportion of patients providing consent who are randomised 2.2. Proportion of patients randomised who do not receive the randomly allocated treatment and reasons why 3. Cross-over is measured as the proportion of patients randomised to the non-operative treatment who receive surgical management, at what time point and reasons why 4. Drop-out rate as defined as the proportion of patients dropping out between randomisation and follow-up at 2 weeks, 3 months and 6 months and reasons why 5. Ability to collect clinical outcome measures: 5.1. Feasibility of gathering patient reported outcome measures and other outcome measures at baseline and follow-up at 2 weeks, 3 months and 6 months (proportion of complete data for each outcome measure; proportion successfully gathered through the British Spine Registry) 5.2. Oswestry Disability Index (ODI): Collected at baseline, 3 and 6 months 5.3. Visual Analogue Scale (VAS) for pain: Collected at baseline, 3 and 6 months 5.4. Short Form-12 (SF12): Collected at baseline, 3 and 6 months 5.5. EuroQol 5 Dimensions (5L) Score (EQ5D-5L): Collected at baseline, 3 and 6 months 5.6. Kyphotic angle is measured using COBB technique at baseline, 2 weeks, 3 months and 6 months. This will be measured from imaging routinely performed at these timepoints | — |
Countries
England, United Kingdom, Wales
Outcome results
None listed