Enhancing Thoracolumbar Burst Fracture Treatment

NCT06561997 | Completed

• 1 other identifier: 2024-42
• Study Type: observational
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

The optimal treatment for neurologically intact thoracolumbar fractures remains controversial. Percutaneous pedicle screw fixation (PPSF) has been proposed for these fractures; however, achieving satisfactory reduction can be challenging. This study applied robot-assisted PPSF to enhance treatment outcomes.

Conditions

Surgery

Keywords

Thoracolumbar fractures; Percutaneous pedicle screw fixation; Robot-assisted; Endplate collapse

Outcome Measures

Primary Outcomes (4)

• The height of sagittal kyphosis

  The height of sagittal kyphosis of the injured vertebral body

  One week post-surgery

• The Cobb's angle of sagittal kyphosis

  The Cobb's angle of sagittal kyphosis of the injured vertebral body

  One week post-surgery

• The height of sagittal kyphosis

  The height of sagittal kyphosis of the injured vertebral body

  One-year post-surgery

• The Cobb's angle of sagittal kyphosis

  The Cobb's angle of sagittal kyphosis of the injured vertebral body

  One-year post-surgery

Secondary Outcomes (4)

• Visual Analogue Scale (VAS) score

  One week post-surgery

• Visual Analogue Scale (VAS) score

  One-year post-surgery

• Oswestry Disability Index (ODI) score

  One week post-surgery

• Oswestry Disability Index (ODI) score

  One-year post-surgery

Study Arms (2)

Robot-assisted group

received percutaneous pedicle screw fixation (PPSF) with robotic assistance

Device: Robot-assisted

Free-hand group

received percutaneous pedicle screw fixation (PPSF) without robotic assistance

Device: Free-hand

Interventions

Robot-assisted DEVICE

received percutaneous pedicle screw fixation (PPSF) with robotic assistance

Robot-assisted group

Free-hand DEVICE

received percutaneous pedicle screw fixation (PPSF) without robotic assistance

Free-hand group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The investigators retrospectively analyzed the medical records of 182 consecutive patients (142 men, 40 women; average age: 38.8 years, age range: 18-64 years) with thoracolumbar burst fractures who had received percutaneous pedicle screw fixation (PPSF) with or without robotic assistance at our hospital between April 2017 and June 2019. The causes of trauma were falls from height (94 patients), traffic accidents (70 patients), and heavy object strikes (18 patients). The time elapsed from fracture occurrence to surgery ranged from 1 to 7 days (average: 2.4 days). The fractures were located at the T11 level in 36 patients, T12 in 73, L1 in 58, and L2 in 15.

You may qualify if:

• had thoracolumbar burst fractures classified as Magerl type A3 underwent short segment posterior fixation (SSPF) showed no signs of osteoporosis on dual-energy X-ray absorptiometry in patients older than 60 years.

You may not qualify if:

• had fractures outside the T11-L2 range presented with old fractures, (iii) had a Parker score ≥ 7 had multiple segment fractures had neurological deficiency caused by fractures had concomitant pain caused by spinal degeneration such as lumbar disc protrusion, spondylolisthesis, spinal stenosis, and/or scoliosis could not receive pedicle screw placement due to bilateral pedicle fractures with displacement had incomplete clinical data or were lost to follow-up

Sponsors & Collaborators

• Peng Liu: lead

Study Sites (1)

"Tianji" 3rd generation orthopedic robot

Chengdu, Sichuan, 610041, China

Location

Related Publications (5)

• Defino HL, Canto FR. Low thoracic and lumbar burst fractures: radiographic and functional outcomes. Eur Spine J. 2007 Nov;16(11):1934-43. doi: 10.1007/s00586-007-0406-y. Epub 2007 Jun 14.

  PMID: 17566793 RESULT

• Kapoen C, Liu Y, Bloemers FW, Deunk J. Pedicle screw fixation of thoracolumbar fractures: conventional short segment versus short segment with intermediate screws at the fracture level-a systematic review and meta-analysis. Eur Spine J. 2020 Oct;29(10):2491-2504. doi: 10.1007/s00586-020-06479-4. Epub 2020 Jun 11.

  PMID: 32529525 RESULT

• Aono H, Ishii K, Tobimatsu H, Nagamoto Y, Takenaka S, Furuya M, Chiaki H, Iwasaki M. Temporary short-segment pedicle screw fixation for thoracolumbar burst fractures: comparative study with or without vertebroplasty. Spine J. 2017 Aug;17(8):1113-1119. doi: 10.1016/j.spinee.2017.03.022. Epub 2017 Mar 31.

  PMID: 28373079 RESULT

• Scholl BM, Theiss SM, Kirkpatrick JS. Short segment fixation of thoracolumbar burst fractures. Orthopedics. 2006 Aug;29(8):703-8. doi: 10.3928/01477447-20060801-14.

  PMID: 16924864 RESULT

• Magerl F, Aebi M, Gertzbein SD, Harms J, Nazarian S. A comprehensive classification of thoracic and lumbar injuries. Eur Spine J. 1994;3(4):184-201. doi: 10.1007/BF02221591.

  PMID: 7866834 RESULT

MeSH Terms

Interventions

Robotic Surgical Procedures

Intervention Hierarchy (Ancestors)

Surgery, Computer-Assisted; Surgical Procedures, Operative; Robotics; Automation; Technology; Technology, Industry, and Agriculture

Study Officials

• Fei Wang, M.D.

  Sichuan Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: August 20, 2024
• Study Start: April 1, 2017
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2020
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)