Lumbar Spinal Degeneration
Conditions
Keywords
Oblique Lumbar Interbody Fusion, Navigation-assisted surgery, Minimally invasive spine surgery
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
MengTingWu
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult male and female patients aged 20 years or older with lumbar spine disease confirmed by clinical evaluation. * Patients who are willing to undergo oblique lumbar interbody fusion (OLIF) via an anterior or oblique lumbar approach. * Patients who have provided written informed consent in accordance with local regulatory requirements.
Exclusion criteria
* Patients who are currently participating in, or have participated within the past 6 months in, another clinical study involving an investigational procedure, device, or drug. * Patients who, in the judgment of the principal investigator, have conditions that may impair their ability to provide written informed consent, such as psychiatric disorders or neurodegenerative diseases. * Patients experiencing uncontrollable or unavoidable events, including but not limited to legally defined infectious diseases, pregnancy, severe accidental injury, or death. * Patients who are unwilling or unable to comply with postoperative follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of pedicle screw placement | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiation exposure | During surgery | Radiation exposure associated with navigation procedures, including cumulative radiation dose and exposure time during surgery. |
| Postoperative complications | Up to 3 months after surgery | Incidence of postoperative complications, including ileus, neurological deficits, and other surgery-related adverse events. |
| Back pain intensity | 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. |
Countries
Taiwan
Outcome results
None listed