Clinical Trials Directory

Trials / Completed

CompletedNCT06561997

Enhancing Thoracolumbar Burst Fracture Treatment

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

Status
Completed
Phase
Study type
Observational
Enrollment
182 (actual)
Sponsor
Peng Liu · Academic / Other
Sex
All
Age
18 Years – 64 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICERobot-assistedreceived percutaneous pedicle screw fixation (PPSF) with robotic assistance
DEVICEFree-handreceived percutaneous pedicle screw fixation (PPSF) without robotic assistance

Timeline

Start date
2017-04-01
Primary completion
2019-06-30
Completion
2020-06-30
First posted
2024-08-20
Last updated
2024-08-20

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT06561997. Inclusion in this directory is not an endorsement.