A Modified Placement of Two Additional Pedicle Screws at the Fracture Level for the Treatment of Thoracolumbar Burst Fractures--a Study Protocol of a Randomised Controlled Trial

Not Applicable

• Conditions: Posterior Short-segment Pedicle Instrumentation
• Interventions: Device: fractured level screws-distraction

• Registration Number: NCT03384368
• Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University

Brief Summary

Controversies exist about the best treatment of burst fractures of the thoracolumbar spine. Adding screws in fractured segment has been proved in many literatures that can improve construct stiffness but sometimes aggravate the trauma of fractured vertebra. Therefore, we are eager to find an optimized placement of two additional pedicle screws at the fracture level for the treatment of thoracolumbar burst fractures. This is the first randomised controlled study investigating efficacy of diverse orders of pedicle screws placement and will provide recommendations for treating patients with thoracolumbar burst fractures.

Detailed Description

A blinded randomised controlled trial (blinding for the patient and statistician, rather than for the clinician and researcher) will be conducted. A total of seventy patients with single thoracolumbar AO type A3 or A4 fractures who are candidates for application of short-segment pedicle screws of fractured vertebrae will be randomly allocated to either the DS group (distraction-screws ) or the SD group (screws-distraction) at a ratio of 1: 1. The primary clinical outcome measures are compression ratio of anterior border of vertebral body height, depth of nail into injured vertebrae and kyphosis (Cobb) angle. Secondary clinical outcome measures are complications, Visual Analogue Scale (VAS) of back and leg pain, neurological function, operating time, intraoperative blood loss, Japanese Orthopaedic Association (JOA) scores and Oswestry Disability Index. These parameters will be evaluated preoperatively, intraoperatively, on day 3 postoperatively and then at 1, 3, 6, 12 and 24 months postoperatively.

Study Timeline

• Study First Submitted: 2017-12-05
• Study First Submitted QC: 2017-12-19
• Study First Posted: 2017-12-27
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-26
• Last Update Posted: 2018-08-28
• Study Start: 2018-12-01
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Distraction-Screw (DS) group	fractured level screws-distraction	four pedicle screws were implanted firstly, then distraction was achieved, two additional screws were introduced at the fracture level at last.
Screw-Distraction (SD) group	fractured level screws-distraction	six pedicle screws were implanted firstly, then distraction was achieved.

Primary Outcome Measures

Name	Time	Method
compression ratio change of anterior border of vertebral body height	preoperatively, intraoperatively, on day 3 postoperatively and then at 1, 3, 6, 12 and 24 months postoperatively	using X-ray fluorescence
Depth of nail into injured vertebrae	at postoperation immediately	using X-ray fluorescence
Kyphosis (Cobb) angle change	preoperatively, intraoperatively, on day 3 postoperatively and then at 1, 3, 6, 12 and 24 months postoperatively	using X-ray fluorescence

Secondary Outcome Measures

Name	Time	Method
Operative time	right after surgery	Unit of Measure is hour
The American Spinal Injury Association (ASIA) impairment scale	preoperatively, on day 3 postoperatively and then at 1, 3, 6, 12 and 24 months postoperatively	Spinal Injury was assessed using ASIA
intraoperative blood loss	right after surgery	Unit of Measure is ml
Complications	at postoperation immediately, 1, 3 and 6 months, and at 1 and 2 years postoperatively.	Pedicle fractures, intraoperative pars fractures, postoperative infection, deep venous thrombosis, nerve injury, and any other direct or indirect surgical complications will be recorded.
pain degree of back and lower limb	preoperatively, on day 3 postoperatively and then at 1, 3, 6, 12 and 24 months postoperatively.	The pain degree of back and lower limb during follow-up will be assessed by the VAS of back pain and VAS of leg pain
Oswestry Disability Index (ODI) change	preoperatively, on day 3 postoperatively and then at 1, 3, 6, 12 and 24 months postoperatively	The Oswestry Disability Index (ODI) will be asssessed by questionnaire
The Japanese Orthopaedic Association (JOA) scores	preoperatively and postoperatively including day 3 and then 1, 3, 6, 12 and 24 months	Functional improvement is expressed by the rate of recovery of the JOA scores

Trial Locations

Locations (1)

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China