Enhancing Thoracolumbar Burst Fracture Treatment

NCT ID: NCT06561997

Last Updated: 2024-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

182 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-01

Study Completion Date

2020-06-30

Brief Summary

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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.

Detailed Description

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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

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Surgery

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Robot-assisted group

received percutaneous pedicle screw fixation (PPSF) with robotic assistance

Robot-assisted

Intervention Type DEVICE

received percutaneous pedicle screw fixation (PPSF) with robotic assistance

Free-hand group

received percutaneous pedicle screw fixation (PPSF) without robotic assistance

Free-hand

Intervention Type DEVICE

received percutaneous pedicle screw fixation (PPSF) without robotic assistance

Interventions

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Robot-assisted

received percutaneous pedicle screw fixation (PPSF) with robotic assistance

Intervention Type DEVICE

Free-hand

received percutaneous pedicle screw fixation (PPSF) without robotic assistance

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peng Liu

OTHER

Sponsor Role lead

Responsible Party

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Peng Liu

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Fei Wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sichuan Provincial People's Hospital

Locations

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"Tianji" 3rd generation orthopedic robot

Chengdu, Sichuan, China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 17566793 (View on PubMed)

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.

Reference Type RESULT
PMID: 32529525 (View on PubMed)

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.

Reference Type RESULT
PMID: 28373079 (View on PubMed)

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.

Reference Type RESULT
PMID: 16924864 (View on PubMed)

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.

Reference Type RESULT
PMID: 7866834 (View on PubMed)

Other Identifiers

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2024-42

Identifier Type: -

Identifier Source: org_study_id

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