Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 2:33 AM
Study NCT ID:
NCT07437118
Status:
COMPLETED
Last Update Posted:
2026-02-27
First Post:
2026-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Three-Dimensional Navigated Lateral Lumbar Interbody Fusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-22', 'studyFirstSubmitDate': '2026-02-22', 'studyFirstSubmitQcDate': '2026-02-22', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of pedicle screw placement', 'timeFrame': 'Postoperative period (3 months after surgery)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Radiation exposure', 'timeFrame': 'During surgery', 'description': 'Radiation exposure associated with navigation procedures, including cumulative radiation dose and exposure time during surgery.'}, {'measure': 'Postoperative complications', 'timeFrame': 'Up to 3 months after surgery', 'description': 'Incidence of postoperative complications, including ileus, neurological deficits, and other surgery-related adverse events.'}, {'measure': 'Back pain intensity', 'timeFrame': 'Preoperative, 1 month, and 3 months after surgery', 'description': 'Back pain intensity assessed using the Visual Analog Scale (VAS), where higher scores indicate greater pain severity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oblique Lumbar Interbody Fusion', 'Navigation-assisted surgery', 'Minimally invasive spine surgery'], 'conditions': ['Lumbar Spinal Degeneration']}, 'descriptionModule': {'briefSummary': '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.\n\nInformation 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.\n\nThis 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.', 'detailedDescription': '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.\n\nAdult 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.\n\nCollected 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult male and female patients aged 20 years or older with lumbar spine disease confirmed by clinical evaluation.\n* Patients who are willing to undergo oblique lumbar interbody fusion (OLIF) via an anterior or oblique lumbar approach.\n* Patients who have provided written informed consent in accordance with local regulatory requirements.\n\nExclusion Criteria:\n\n* 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.\n* 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.\n* Patients experiencing uncontrollable or unavoidable events, including but not limited to legally defined infectious diseases, pregnancy, severe accidental injury, or death.\n* Patients who are unwilling or unable to comply with postoperative follow-up.'}, 'identificationModule': {'nctId': 'NCT07437118', 'briefTitle': 'Analysis of Three-Dimensional Navigated Lateral Lumbar Interbody Fusion', 'organization': {'class': 'OTHER', 'fullName': 'Cheng-Hsin General Hospital'}, 'officialTitle': 'Analysis of Three-Dimensional Navigated Lateral Lumbar Interbody Fusion', 'orgStudyIdInfo': {'id': 'CHGH-IRB (857)110-03'}, 'secondaryIdInfos': [{'id': 'CHGH-IRB-857-110-03', 'type': 'OTHER', 'domain': 'Cheng Hsin General Hospital Institutional Review Board'}]}, 'contactsLocationsModule': {'locations': [{'zip': '112', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Cheng Hsin General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MengTingWu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Attending Neurosurgeon', 'investigatorFullName': 'MengTingWu', 'investigatorAffiliation': 'Cheng-Hsin General Hospital'}}}}