Posterior Short-segment Pedicle InstrumentationNCT03384368
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
A study testing fractured level screws-distraction in people with Posterior Short-segment Pedicle Instrumentation, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posterior Short-segment Pedicle Instrumentation
- What is being tested?
- fractured level screws-distraction
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2018to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or above.
- single thoracolumbar burst fractures
- AO type A3 or A4 fractures
- Thoracolumbar Injury Classification and Severity Score (TLICS) of more than 4 and duration of < 2 weeks
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
WENFEI NI
About this study
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.
Read the 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.
- Being tested
- fractured level screws-distraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fractured level screws-distractionDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Screw-Distraction (SD) group | Placebo comparator | six pedicle screws were implanted firstly, then distraction was achieved. Receives: Device: fractured level screws-distraction |
| Distraction-Screw (DS) group | Experimental | four pedicle screws were implanted firstly, then distraction was achieved, two additional screws were introduced at the fracture level at last. Receives: Device: fractured level screws-distraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
compression ratio change of anterior border of vertebral body height
using X-ray fluorescence
Measured: preoperatively, intraoperatively, on day 3 postoperatively and then at 1, 3, 6, 12 and 24 months postoperatively
Depth of nail into injured vertebrae
using X-ray fluorescence
Measured: at postoperation immediately
Kyphosis (Cobb) angle change
using X-ray fluorescence
Measured: preoperatively, intraoperatively, on day 3 postoperatively and then at 1, 3, 6, 12 and 24 months postoperatively
Secondary outcomes (7)
Operative time
Unit of Measure is hour
Measured: right after surgery
intraoperative blood loss
Unit of Measure is ml
Measured: right after surgery
Complications
Pedicle fractures, intraoperative pars fractures, postoperative infection, deep venous thrombosis, nerve injury, and any other direct or indirect surgical complications will be recorded.
Measured: at postoperation immediately, 1, 3 and 6 months, and at 1 and 2 years postoperatively.
pain degree of back and lower limb
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
Measured: preoperatively, on day 3 postoperatively and then at 1, 3, 6, 12 and 24 months postoperatively.
Oswestry Disability Index (ODI) change
The Oswestry Disability Index (ODI) will be asssessed by questionnaire
Measured: preoperatively, on day 3 postoperatively and then at 1, 3, 6, 12 and 24 months postoperatively
The Japanese Orthopaedic Association (JOA) scores
Functional improvement is expressed by the rate of recovery of the JOA scores
Measured: preoperatively and postoperatively including day 3 and then 1, 3, 6, 12 and 24 months
The American Spinal Injury Association (ASIA) impairment scale
Spinal Injury was assessed using ASIA
Measured: preoperatively, on day 3 postoperatively and then at 1, 3, 6, 12 and 24 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2017
- Study start1 Dec 2018 (estimated)
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posterior Short-segment Pedicle InstrumentationStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03384368
- Sponsor's protocol ID
- SAHoWMU-CR2017-08-115
- Status last verified
- Aug 2018
- First submitted
- 5 Dec 2017
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hu ZC, Li XB, Feng ZH, Wang JQ, Gong LF, Xuan JW, Fu X, Jiang BJ, Wu L, Ni WF. Modified pedicle screw placement at the fracture level for treatment of thoracolumbar burst fractures: a study protocol of a randomised controlled trial. BMJ Open. 2019 Jan 28;9(1):e024110. doi: 10.1136/bmjopen-2018-024110.
PubMed 30696677
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03384368
- Acronym / sponsor ID
- SAHoWMU-CR2017-08-115
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 27 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Screw-Distraction (SD) group | Placebo comparator | Device: fractured level screws-distractionsix pedicle screws were implanted firstly, then distraction was achieved. |
| Distraction-Screw (DS) group | Experimental | Device: fractured level screws-distractionfour pedicle screws were implanted firstly, then distraction was achieved, two additional screws were introduced at the fracture level at last. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or above.
- single thoracolumbar burst fractures
- AO type A3 or A4 fractures
- Thoracolumbar Injury Classification and Severity Score (TLICS) of more than 4 and duration of < 2 weeks
- application of posterior short-segment pedicle screws instrumentation at the fracture level Exclusion criteria
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fractured level screws-distractionfour 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 | Device | Distraction-Screw (DS) group, Screw-Distraction (SD) group |
Primary outcome
compression ratio change of anterior border of vertebral body height
Time frame: 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
Time frame: at postoperation immediately
using X-ray fluorescence
Kyphosis (Cobb) angle change
Time frame: preoperatively, intraoperatively, on day 3 postoperatively and then at 1, 3, 6, 12 and 24 months postoperatively
using X-ray fluorescence
7 secondary outcomes
Operative time
Time frame: right after surgery
intraoperative blood loss
Time frame: right after surgery
Complications
Time frame: at postoperation immediately, 1, 3 and 6 months, and at 1 and 2 years postoperatively.
pain degree of back and lower limb
Time frame: preoperatively, on day 3 postoperatively and then at 1, 3, 6, 12 and 24 months postoperatively.
Oswestry Disability Index (ODI) change
Time frame: preoperatively, on day 3 postoperatively and then at 1, 3, 6, 12 and 24 months postoperatively
The Japanese Orthopaedic Association (JOA) scores
Time frame: preoperatively and postoperatively including day 3 and then 1, 3, 6, 12 and 24 months
The American Spinal Injury Association (ASIA) impairment scale
Time frame: preoperatively, on day 3 postoperatively and then at 1, 3, 6, 12 and 24 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Derived from this study: PubMed 30696677Hu ZC, Li XB, Feng ZH, Wang JQ, Gong LF, Xuan JW, Fu X, Jiang BJ, Wu L, Ni WF. Modified pedicle screw placement at the fracture level for treatment of thoracolumbar burst fractures: a study protocol of a randomised controlled trial. BMJ Open. 2019 Jan 28;9(1):e024110. doi: 10.1136/bmjopen-2018-024110.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fractured level screws-distraction in people with Posterior Short-segment Pedicle Instrumentation, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wen-Fei Ni, Pro (86057788002814, wenfeini@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compression ratio change of anterior border of vertebral body height (time frame: preoperatively, intraoperatively, on day 3 postoperatively and then at 1, 3, 6, 12 and 24 months postoperatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03384368, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2018; AzTrials last refreshed its copy on 6 Nov 2026.