Analysis of Three-Dimensional Navigated Lateral Lumbar Interbody Fusion

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.

Study Overview

• Status: Completed
• Conditions: Lumbar Spinal Degeneration

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.

• Study Type: Observational
• Enrollment (Actual): 11

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 112
    • Cheng Hsin General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients aged 20 years or older with lumbar degenerative disease who underwent oblique lumbar interbody fusion (OLIF) with navigation assistance as part of routine clinical care at a single tertiary medical center. All participants received surgical treatment based on standard clinical indications and provided written informed consent. Postoperative clinical and radiographic outcomes were evaluated during routine follow-up.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of pedicle screw placement	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.	Postoperative period (3 months after surgery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiation exposure	Radiation exposure associated with navigation procedures, including cumulative radiation dose and exposure time during surgery.	During surgery
Postoperative complications	Incidence of postoperative complications, including ileus, neurological deficits, and other surgery-related adverse events.	Up to 3 months after surgery
Back pain intensity	Back pain intensity assessed using the Visual Analog Scale (VAS), where higher scores indicate greater pain severity.	Preoperative, 1 month, and 3 months after surgery

Collaborators and Investigators

• Sponsor: MengTingWu

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2021
• Primary Completion (Actual): December 21, 2021
• Study Completion (Actual): June 21, 2022

Study Registration Dates

• First Submitted: February 22, 2026
• First Submitted That Met QC Criteria: February 22, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 22, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Oblique Lumbar Interbody Fusion; Minimally invasive spine surgery; Navigation-assisted surgery
• Other Study ID Numbers: CHGH-IRB (857)110-03; CHGH-IRB-857-110-03 (Other Identifier: Cheng Hsin General Hospital Institutional Review Board)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: individual participant data (IPD) will not be shared outside the study team. This is a single-center observational study, and all data were collected as part of routine clinical care. Data sharing is not planned due to patient privacy considerations and the absence of a pre-specified data sharing agreement in the study protocol and informed consent.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No