Enhancing Thoracolumbar Burst Fracture Treatment

Enhancing Thoracolumbar Burst Fracture Treatment: The Advantage of Robot-Assisted Posterior Fixation for Improved Reduction and Collapse Prevention

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.

Study Overview

• Status: Completed
• Conditions: Surgery
• Intervention / Treatment: Device: Robot-assisted; Device: Free-hand

Detailed Description

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. The investigators retrospectively analyzed the medical records of 182 consecutive patients with thoracolumbar burst fractures treated with PPSF, with (n=88) and without (n=94) robotic assistance, at our hospital between April 2017 and June 2019. The participants were evaluated surgical time, intraoperative bleeding, radiation dosage, accuracy of screw placement, fractured vertebral height, Cobb's angle, surgery efficacy (pain relief and limb function), and implant failure to assess the potential advantages of robot-assisted PPSF. Robot-assisted PPSF for thoracolumbar burst fractures reduces surgery time and intraoperative bleeding, enhances screw placement accuracy, and achieves better reduction compared to the free-hand technique. This approach effectively prevents endplate collapse and recurrence of kyphosis post-surgery. However, functional recovery in the short term is similar between the two methods.

• Study Type: Observational
• Enrollment (Actual): 182

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • "Tianji" 3rd generation orthopedic robot

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Robot-assisted group; received percutaneous pedicle screw fixation (PPSF) with robotic assistance	Device: Robot-assisted; received percutaneous pedicle screw fixation (PPSF) with robotic assistance
Free-hand group; received percutaneous pedicle screw fixation (PPSF) without robotic assistance	Device: Free-hand; received percutaneous pedicle screw fixation (PPSF) without robotic assistance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS) score	Visual Analogue Scale (VAS; out of a total score of 10, 0 corresponds to no pain and 10 refers to unbearable pain)	One week post-surgery
Visual Analogue Scale (VAS) score	Visual Analogue Scale (VAS; out of a total score of 10, 0 corresponds to no pain and 10 refers to unbearable pain)	One-year post-surgery
Oswestry Disability Index (ODI) score	Oswestry Disability Index (ODI; the questionnaire is composed of 10 aspects for pain, self-care, extraction, walking, sitting, standing, sleeping, sexual life, social life, and tourism, with 0-5 points for each item. 0% scores corresponded to normal function and 100% corresponded to severe dysfunction)	One week post-surgery
Oswestry Disability Index (ODI) score	Oswestry Disability Index (ODI; the questionnaire is composed of 10 aspects for pain, self-care, extraction, walking, sitting, standing, sleeping, sexual life, social life, and tourism, with 0-5 points for each item. 0% scores corresponded to normal function and 100% corresponded to severe dysfunction)	One-year post-surgery

Collaborators and Investigators

• Sponsor: Peng Liu
• Investigators: Principal Investigator: Fei Wang, M.D., Sichuan Provincial People's Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: July 19, 2024
• First Submitted That Met QC Criteria: August 19, 2024
• First Posted (Actual): August 20, 2024

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Robot-assisted; Thoracolumbar fractures; Percutaneous pedicle screw fixation; Endplate collapse
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 2024-42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No