Enhancing Thoracolumbar Burst Fracture Treatment
- Conditions
- Surgery
- Interventions
- Device: Free-handDevice: Robot-assisted
- Registration Number
- NCT06561997
- Lead Sponsor
- Peng Liu
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 182
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.
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Free-hand group Free-hand received percutaneous pedicle screw fixation (PPSF) without robotic assistance Robot-assisted group Robot-assisted received percutaneous pedicle screw fixation (PPSF) with robotic assistance
- Primary Outcome Measures
Name Time Method The height of sagittal kyphosis One-year post-surgery The height of sagittal kyphosis of the injured vertebral body
The Cobb's angle of sagittal kyphosis One-year post-surgery The Cobb's angle of sagittal kyphosis of the injured vertebral body
- Secondary Outcome Measures
Name Time Method Oswestry Disability Index (ODI) score 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)
Visual Analogue Scale (VAS) score 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)
Trial Locations
- Locations (1)
"Tianji" 3rd generation orthopedic robot
🇨🇳Chengdu, Sichuan, China