Surgical Treatment of the Thoracolumbar Spine Fractures.
1 other identifier
interventional
60
1 country
1
Brief Summary
The thoracolumbar segment fractures are the most frequent along the spine, and surgical treatment is indicated in unstable fractures. Surgical treatment has been performed through the posterior fixation pedicle fixation systems, and where necessary complemented by decompression of the spinal arthrodesis and previous channel. Surgical treatment has been performed by conventional open approach through the posterior incision on the midline, and detachment and removal of paraspinal muscles to access the posterior vertebral elements. The percutaneous minimally invasive surgery was introduced in the context of spinal surgery to reduce the morbidity associated with conventional open approach. It has been reported the lowest bleeding intra- and postoperative period, less pain, shorter hospital stay, rehabilitation and return to work faster with less use of minimally invasive percutaneous approach of the spine. However, predominates in the literature of clinical case reports and few prospective and randomized clinical trials. The performance of prospective randomized clinical trials have been required for the evaluation of the benefits of minimally invasive surgery in the treatment of the thoracolumbar spine fractures. The objective of the study is to compare the surgical treatment of fractures of the thoracolumbar spine using the conventional open approach or minimally invasive percutaneous approach to the stabilization of the vertebral segment affected, and using similar type of pedicle spinal fixation system. Patients will be evaluated in the preoperative, postoperative, 1,2,3,6,12 and 24 months by parameters related to the perioperative (intraoperative bleeding, surgery time), clinical (VAS, SF-36, HADS, EQ-5D-5L), images (radiographs and computed tomography). The study results will impact the guidelines of the surgical treatment of thoracolumbar spine fractures and may indicate the advantages or disadvantages of using surgery through conventional open approach to minimally invasive percutaneous surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2017
CompletedFirst Posted
Study publicly available on registry
October 20, 2017
CompletedStudy Start
First participant enrolled
May 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedOctober 6, 2021
September 1, 2021
3.6 years
May 19, 2017
September 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative pain
The intensity of pain will be measured by Visual Analogue Scale (VAS).
up to 24 months
Secondary Outcomes (17)
Postoperative complications
immediate postoperative, and 1,2,3,6,12 and 24 months of followup
Postoperative adverse events
immediate postoperative, and 1,2,3,6,12 and 24 months of followup
Breakage or release of implants through radiographs
immediate postoperative, and 1,2,3,6,12 and 24 months of followup
Breakage or release of implants through CT scan
immediate postoperative, and 1,2,3,6,12 and 24 months of followup
Total costs
24 months
- +12 more secondary outcomes
Study Arms (2)
Conventional open surgery
ACTIVE COMPARATORFixation of a proximal vertebra, a vertebra distal to the fractured vertebra, and also of the fractured vertebra with a pedicle fixation system using the conventional open to implant placement without subsequent arthrodesis.
Minimally invasive percutaneous surgery
EXPERIMENTALFixation of a proximal vertebra, a vertebra distal to the fractured vertebra, and also of the fractured vertebra with a pedicle fixation system using the percutaneous minimally invasive approach to implant placement without subsequent arthrodesis.
Interventions
Surgical treatment will be performed by stabilizing the fractured vertebral segment (proximal vertebra and vertebra distal to fractured vertebra and fractured vertebra) by means of a 6.5 mm or 6.5 mm diameter polyaxial pedicle screw system. In the fractured proximal and distal vertebrae to the vertebrae, screws will be used up to the vertebral body and fractured vertebra will use shorter screws that do not penetrate the vertebral body. In the fractured vertebra, single or bilateral pedicle screw will be used according to the degree of involvement of the pedicle of the fractured vertebra. The vertebral fixation system will be applied through the conventional open approach (group A).
Surgical treatment will be performed by stabilizing the fractured vertebral segment (proximal vertebra and vertebra distal to fractured vertebra and fractured vertebra) by means of a 6.5 mm or 6.5 mm diameter polyaxial pedicle screw system. In the fractured proximal and distal vertebrae to the vertebrae, screws will be used up to the vertebral body and fractured vertebra will use shorter screws that do not penetrate the vertebral body. In the fractured vertebra, single or bilateral pedicle screw will be used according to the degree of involvement of the pedicle of the fractured vertebra. The vertebral fixation system will be applied through the minimally invasive percutaneous approach (group B) according to allocation after randomization.
Eligibility Criteria
You may qualify if:
- Single level fracture
- Fracture T11-L5
- Posterior Stabilization Indication
You may not qualify if:
- Fracture in more than 1 level
- Osteoporotic fracture
- Pathological fracture
- Previous history of surgery
- Deformity
- Mental disease
- TCE
- Posterior vertebral canal open decompression
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital das Clinicas.University of Sao Paulo
Ribeirão Preto, São Paulo, 14.048-900, Brazil
Related Publications (1)
Defino HLA, Costa HRT, Nunes AA, Nogueira Barbosa M, Romero V. Open versus minimally invasive percutaneous surgery for surgical treatment of thoracolumbar spine fractures- a multicenter randomized controlled trial: study protocol. BMC Musculoskelet Disord. 2019 Aug 31;20(1):397. doi: 10.1186/s12891-019-2763-1.
PMID: 31472691DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Helton LA Defino, MD, PhD.
Department of Orthopedics and Traumatology.University of Sao Paulo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD in Orthopedics and Traumatology
Study Record Dates
First Submitted
May 19, 2017
First Posted
October 20, 2017
Study Start
May 9, 2018
Primary Completion
December 10, 2021
Study Completion
December 1, 2023
Last Updated
October 6, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share