Posterior Short-segment Pedicle Instrumentation
Conditions
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.
Interventions
DEVICEfractured level screws-distraction
four pedicle screws were implanted into the upper vertebra and the lower vertebral body of the fractured vertebra. Then, immediate reduction and decompression were achieved by applying distraction of rod. Finally, two additional screws were introduced at fracture level
Sponsors
Second Affiliated Hospital of Wenzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years of age or above. 2. single thoracolumbar burst fractures 3. AO type A3 or A4 fractures 4. Thoracolumbar Injury Classification and Severity Score (TLICS) of more than 4 and duration of \< 2 weeks 5. application of posterior short-segment pedicle screws instrumentation at the fracture level
Exclusion criteria
1\. previous pedicle instrumentation at the same level 2. multi-segmental thoracolumbar fractures or not AO type A3 or A4 are found 3. pregnancy 4. active infection or surgical site of the previous infection 5. planned emigration abroad within 2 years after inclusion 6. suffering from illness or long-term use of certain drugs affecting the stability of the spinal environment, such as metabolic bone disease, spinal tuberculosis and so on 7. the current use of anticoagulant (such as warfarin) or postoperative heparin for more than 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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. |
Countries
China
Contacts
Primary ContactWen-Fei Ni, Pro
Outcome results
None listed