Treatment of stable thoracolumbar fractures: feasibility

Not Applicable

Completed

• Conditions: Thoracolumbar fractures; Musculoskeletal Diseases; Injuries to the abdomen, lower back, lumbar spine and pelvis

• Registration Number: ISRCTN12094890
• Lead Sponsor: South Tees Hospitals NHS Foundation Trust

Brief Summary

2020 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/32190347 protocol (added 20/03/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34780323/ (added 16/11/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-22
• Study Completion: 2019-09-30
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recruitment rate, defined as the proportion of eligible participants who are randomised during the recruitment period.