Clinical trial NCT06561997: Enhancing Thoracolumbar Burst Fracture Treatment
Official title: Enhancing Thoracolumbar Burst Fracture Treatment: The Advantage of Robot-Assisted Posterior Fixation for Improved Reduction and Collapse Prevention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Keywords: Thoracolumbar fractures
Percutaneous pedicle screw fixation
Robot-assisted
Endplate collapse
Lead sponsor: Sichuan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2024-08-20
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The height of sagittal kyphosis
timeFrame: One week post-surgery
measure: The Cobb's angle of sagittal kyphosis
timeFrame: One week post-surgery
measure: The height of sagittal kyphosis
timeFrame: One-year post-surgery
measure: The Cobb's angle of sagittal kyphosis
timeFrame: One-year post-surgery
Secondary outcomes:
measure: Visual Analogue Scale (VAS) score
timeFrame: One week post-surgery
measure: Visual Analogue Scale (VAS) score
timeFrame: One-year post-surgery
measure: Oswestry Disability Index (ODI) score
timeFrame: One week post-surgery
measure: Oswestry Disability Index (ODI) score
timeFrame: One-year post-surgery
Other outcomes:
Locations:
city: Chengdu
country: China
facility: "Tianji" 3rd generation orthopedic robot
state: Sichuan
Study officials:
affiliation: Sichuan Provincial People's Hospital
name: Fei Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.