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SurgeryNCT06561997

Enhancing Thoracolumbar Burst Fracture Treatment

An observational study of Surgery, run by Peng Liu at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Surgery
What is being tested?
Robot-assisted and Free-hand
Type of treatment
Medical device
How many people
182 participants
Where
1 siteChina
Study dates
1 Apr 2017to 30 Jun 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • "Tianji" 3rd generation orthopedic robot

    Chengdu, Sichuan, 610041

Other trials in China

About this study

Official title: 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.

Read the 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.

Conditions
Surgery
Being tested
Robot-assisted, Free-hand
Keywords
Thoracolumbar fractures, Percutaneous pedicle screw fixation, Robot-assisted, Endplate collapse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Robot-assistedDevice

    received percutaneous pedicle screw fixation (PPSF) with robotic assistance

  • Free-handDevice

    received percutaneous pedicle screw fixation (PPSF) without robotic assistance

Study groups in NCT06561997
Study groupRoleWhat they receive
Robot-assisted groupreceived percutaneous pedicle screw fixation (PPSF) with robotic assistance
Receives: Device: Robot-assisted
Free-hand groupreceived percutaneous pedicle screw fixation (PPSF) without robotic assistance
Receives: Device: Free-hand

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The height of sagittal kyphosis

    The height of sagittal kyphosis of the injured vertebral body

    Measured: One week post-surgery

  2. The Cobb's angle of sagittal kyphosis

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

    Measured: One week post-surgery

  3. The height of sagittal kyphosis

    The height of sagittal kyphosis of the injured vertebral body

    Measured: One-year post-surgery

  4. The Cobb's angle of sagittal kyphosis

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

    Measured: One-year post-surgery

Secondary outcomes (4)

  1. 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)

    Measured: One week post-surgery

  2. 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)

    Measured: One-year post-surgery

  3. 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)

    Measured: One week post-surgery

  4. 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)

    Measured: One-year post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2024
  2. Study start1 Apr 2017
  3. Primary completion30 Jun 2019
  4. Study completion30 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
182 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06561997
Sponsor's protocol ID
2024-42
Status last verified
Aug 2024
First submitted
19 Jul 2024
Last updated
20 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 17566793

  • 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.

    PubMed 32529525

  • 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.

    PubMed 28373079

  • 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.

    PubMed 16924864

  • 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.

    PubMed 7866834

Questions about this trial

What is this clinical trial studying?

An observational study of Surgery, run by Peng Liu at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The height of sagittal kyphosis (time frame: One week post-surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06561997, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.

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