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

NCT ID: NCT03384368

Last Updated: 2018-08-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2019-12-30

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.

Conditions

Posterior Short-segment Pedicle Instrumentation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Screw-Distraction (SD) group

six pedicle screws were implanted firstly, then distraction was achieved.

Group Type: PLACEBO_COMPARATOR

fractured level screws-distraction

Intervention Type: DEVICE

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

Distraction-Screw (DS) group

four pedicle screws were implanted firstly, then distraction was achieved, two additional screws were introduced at the fracture level at last.

Group Type: EXPERIMENTAL

fractured level screws-distraction

Intervention Type: DEVICE

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

Interventions

fractured 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

Intervention Type: DEVICE

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wen-Fei Ni, Pro

Role: CONTACT

wenfeini@yeah.net

86057788002814

Facility Contacts

WENFEI NI

Role: primary

References

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.

Reference Type: DERIVED

PMID: 30696677 (View on PubMed)

Other Identifiers

SAHoWMU-CR2017-08-115

Identifier Type: -

Identifier Source: org_study_id