Cheng Hsin General Hospital
Taipei, 112, Taiwan
NCT Number: NCT07437118
This observational study evaluates the clinical outcomes and procedural characteristics of navigation-assisted oblique lumbar interbody fusion (OLIF) in patients with lumbar degenerative disease. Between July 2021 and December 2021, adult patients undergoing OLIF with robotic or navigation assistance at Cheng Hsin General Hospital were included. Navigation systems were used to guide interbody cage placement and percutaneous pedicle screw insertion.
Information regarding operative time, intraoperative blood loss, radiation exposure to patients and operating room staff, and postoperative complications was collected. Clinical outcomes, including back and leg pain and lumbar function, were assessed during routine postoperative follow-up.
This study aims to describe the feasibility and short-term outcomes of navigation-assisted OLIF, including screw placement accuracy and early postoperative clinical improvement, and to provide additional clinical information regarding the use of navigation systems in minimally invasive lumbar fusion surgery.
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Notify Me20 year and older
All sexes
Observational
Taipei, 112, Taiwan
This is a single-center observational study designed to assess procedural characteristics and short-term clinical outcomes associated with navigation-assisted oblique lumbar interbody fusion (OLIF) performed as part of routine clinical care.
Adult patients with lumbar degenerative disease who underwent OLIF with navigation assistance were included. Navigation systems were utilized to assist interbody cage placement and percutaneous pedicle screw insertion. No experimental interventions, randomization, or deviations from standard clinical practice were performed.
Collected data included operative time, estimated blood loss, radiation exposure related to navigation procedures, and perioperative complications. Clinical outcomes such as back and leg pain and lumbar function were evaluated during routine postoperative follow-up visits at 1 and 3 months after surgery.
The purpose of this study is to describe the feasibility and short-term performance of navigation-assisted OLIF and to contribute clinical data regarding the application of navigation systems in minimally invasive lumbar fusion procedures.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Postoperative period (3 months after surgery)
Accuracy of pedicle screw placement assessed on postoperative computed tomography (CT) scans using the modified Gertzbein and Robbins classification. Screws were classified based on the degree of pedicle wall breach, and the proportion of accurately placed screws was calculated.
Time frame: During surgery
Radiation exposure associated with navigation procedures, including cumulative radiation dose and exposure time during surgery.
Time frame: Up to 3 months after surgery
Incidence of postoperative complications, including ileus, neurological deficits, and other surgery-related adverse events.
Time frame: Preoperative, 1 month, and 3 months after surgery
Back pain intensity assessed using the Visual Analog Scale (VAS), where higher scores indicate greater pain severity.
MengTingWu
Other
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