Lumbar Spinal DegenerationNCT07437118
Analysis of Three-Dimensional Navigated Lateral Lumbar Interbody Fusion
An observational study of Lumbar Spinal Degeneration, run by MengTingWu at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lumbar Spinal Degeneration
- How many people
- 11 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Jul 2021to 21 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Lumbar Spinal Degeneration
- Keywords
- Oblique Lumbar Interbody Fusion, Navigation-assisted surgery, Minimally invasive spine surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative period (3 months after surgery)
Secondary outcomes (3)
Radiation exposure
Radiation exposure associated with navigation procedures, including cumulative radiation dose and exposure time during surgery.
Measured: During surgery
Postoperative complications
Incidence of postoperative complications, including ileus, neurological deficits, and other surgery-related adverse events.
Measured: 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.
Measured: Preoperative, 1 month, and 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start18 Jul 2021
- Primary completion21 Dec 2021
- Study completion21 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- MengTingWu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, MengTingWu, Cheng-Hsin General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437118
- Sponsor's protocol ID
- CHGH-IRB (857)110-03
- Other IDs
- CHGH-IRB-857-110-03
- Status last verified
- Feb 2026
- First submitted
- 22 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Three-Dimensional Navigated Lateral Lumbar Interbody Fusion
- ClinicalTrials.gov ID
- NCT07437118
- Acronym / sponsor ID
- CHGH-IRB (857)110-03
- Conditions
- Lumbar Spinal Degeneration
- Keywords
- Oblique Lumbar Interbody Fusion, Navigation-assisted surgery, Minimally invasive spine surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- MengTingWuUniversity, hospital or other
- Study start
- 18 Jul 2021 (actual)
- Primary completion
- 21 Dec 2021 (actual)
- Study completion
- 21 Jun 2022 (actual)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of pedicle screw placement
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.
3 secondary outcomes
Radiation exposure
Time frame: During surgery
Postoperative complications
Time frame: Up to 3 months after surgery
Back pain intensity
Time frame: Preoperative, 1 month, and 3 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spinal Degeneration, run by MengTingWu at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of pedicle screw placement (time frame: Postoperative period (3 months after surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.