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Completed

NCT Number: NCT06561997

Enhancing Thoracolumbar Burst Fracture Treatment

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.

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Key information

Conditions

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

"Tianji" 3rd generation orthopedic robot

Chengdu, Sichuan, 610041, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robot-assisted

Device

received percutaneous pedicle screw fixation (PPSF) with robotic assistance

Free-hand

Device

received percutaneous pedicle screw fixation (PPSF) without robotic assistance

Primary outcomes

  1. The height of sagittal kyphosis

    Time frame: One week post-surgery

    The height of sagittal kyphosis of the injured vertebral body

  2. The Cobb's angle of sagittal kyphosis

    Time frame: One week post-surgery

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

  3. The height of sagittal kyphosis

    Time frame: One-year post-surgery

    The height of sagittal kyphosis of the injured vertebral body

  4. The Cobb's angle of sagittal kyphosis

    Time frame: One-year post-surgery

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

Secondary outcomes

  1. Visual Analogue Scale (VAS) score

    Time frame: One week post-surgery

    Visual Analogue Scale (VAS; out of a total score of 10, 0 corresponds to no pain and 10 refers to unbearable pain)

  2. Visual Analogue Scale (VAS) score

    Time frame: One-year post-surgery

    Visual Analogue Scale (VAS; out of a total score of 10, 0 corresponds to no pain and 10 refers to unbearable pain)

  3. Oswestry Disability Index (ODI) score

    Time frame: One week post-surgery

    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)

  4. Oswestry Disability Index (ODI) score

    Time frame: One-year post-surgery

    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)

Sponsors and collaborators

Lead sponsor

Peng Liu

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Aug 20, 2024
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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