Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
Study NCT ID:
NCT07279051
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-12
First Post:
2025-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Modified Mini-Open TLIF vs Traditional Open TLIF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 224}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-30', 'studyFirstSubmitDate': '2025-11-16', 'studyFirstSubmitQcDate': '2025-11-30', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oswestry Disability Index (ODI)', 'timeFrame': 'preoperatively and 1/3/12/24 months postoperatively', 'description': 'Oswestry Disability Index (ODI), a 10-item questionnaire scored from 0 (no disability) to 100 (maximum disability), with higher scores indicating worse disability.'}], 'secondaryOutcomes': [{'measure': 'Pain VAS scores', 'timeFrame': 'preoperatively and 1/3/12/24 months postoperatively', 'description': 'Pain Visual Analog Scale (VAS) score, ranging from 0 (no pain) to 10 (worst pain), with higher scores indicating more severe pain.'}, {'measure': 'Zurich Claudication Questionnaire (ZCQ) score', 'timeFrame': 'Preoperative and 1/3/12 months postoperative', 'description': 'Zurich Claudication Questionnaire (ZCQ) score, which includes symptom severity (range 1 to 5, lower scores indicate milder symptoms) and physical function (range 1 to 5, lower scores indicate less disability).'}, {'measure': 'Brock Quality of Life Five Dimensions (EQ-5D-3L) questionnaire score', 'timeFrame': '1/24 month postoperatively', 'description': 'EuroQol 5-Dimension 3-Level (EQ-5D-3L) questionnaire score, ranging from -0.59 to 1.0, with higher scores indicating better quality of life.'}, {'measure': 'Operative Time', 'timeFrame': 'Immediately upon surgery conclusion', 'description': 'Operative Time, measured in minutes'}, {'measure': 'Intraoperative Blood Loss', 'timeFrame': 'Immediately upon surgery conclusion', 'description': 'Intraoperative Blood Loss, measured in milliliters'}, {'measure': 'Transfusion Rate', 'timeFrame': 'From surgery start until hospital discharge, assessed up to 30 days.'}, {'measure': 'Time to Ambulation', 'timeFrame': 'Time from surgery to first ambulation, assessed during postoperative hospital stay up to 30 days'}, {'measure': 'Length of Hospital Stay', 'timeFrame': 'Length of hospital stay from surgery to discharge, assessed up to 30 days.'}, {'measure': 'Incidence of complications', 'timeFrame': 'From surgery start until 24 months postoperatively.', 'description': 'e.g., nerve injury, infection, screw loosening'}, {'measure': 'Radiographic fusion rate', 'timeFrame': '12 months postoperative', 'description': 'Evaluated by CT (Bridwell classification)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spinal Stenosis Lumbar']}, 'descriptionModule': {'briefSummary': "This clinical study aims to find out if a modified mini-open spine surgery (modified mini-open transforaminal lumbar interbody fusion，mMO-TLIF) is as good as, or better than, the traditional open surgery (traditional transforaminal lumbar interbody fusion，traditional TLIF) for treating low back pain, leg pain, and walking difficulties caused by lumbar spinal stenosis with instability. The study will also look at the safety of both surgeries.\n\nIt is designed to answer these main questions:\n\nIs the mMO-TLIF surgery as good as the traditional TLIF surgery at improving patients' lower back function and quality of life? Does the mMO-TLIF surgery reduce blood loss during the operation and shorten hospital stays and recovery time? What medical problems (like infections or nerve injuries) might patients experience after having the mMO-TLIF surgery? Researchers will compare the results of the mMO-TLIF surgery group with the traditional TLIF surgery group to see which one works better.\n\nParticipants will:\n\nBe randomly assigned to receive either the mMO-TLIF minimally invasive surgery or the traditional TLIF open surgery.\n\nCome back to the hospital for check-ups before surgery, and then at 1 month, 3 months, 12 months and 24 months after surgery.\n\nDuring these check-ups, they will have physical exams, fill out questionnaires about their symptoms, dysfunction and quality of life, and get X-rays or CT scans to see how their bones are healing."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged between 18 and 80 years.\n* Presence of unilateral neurogenic claudication or radicular pain in the lower limbs, with failure to respond to at least 3 months of conservative treatment.\n* Presence of bilateral neurogenic claudication or radicular pain in the lower limbs, but with complete resolution of neurological symptoms in at least one lower limb during recumbency and an unremarkable physical examination, alongside failure to respond to at least 3 months of conservative treatment.\n* Radiologically confirmed single- or two-level lumbar spinal stenosis on MRI, with evidence of instability specifically at the stenotic level(s) on standing lateral radiographs.\n* The mMO-TLIF or TLIF surgical procedure is performed by the same lead surgeon at each participating investigational site.\n* Subjects voluntarily participate and provide written informed consent.\n\nExclusion Criteria:\n\n* Presence of bilateral radicular pain in the lower limbs that does not completely resolve at rest.\n* History of previous lumbar spine trauma or surgery.\n* Presence of spinal infection, tuberculosis, or tumor.\n* Contraindications to surgery, such as severe systemic medical diseases, coagulation disorders, severe active infectious diseases, or osteoporosis.\n* Significant intervertebral space collapse, presence of bony ankylosis, etc.\n* Incomplete data.'}, 'identificationModule': {'nctId': 'NCT07279051', 'acronym': 'TLIF', 'briefTitle': 'Modified Mini-Open TLIF vs Traditional Open TLIF', 'organization': {'class': 'OTHER', 'fullName': "The First People's Hospital of Lianyungang"}, 'officialTitle': 'Modified Mini-Open TLIF Versus Traditional Open TLIF for Lumbar Spinal Stenosis : A Prospective, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'KY-20250801001-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mMO-TLIF surgery group', 'description': 'The experimental group (mMO-TLIF group) underwent modified Mini-Open Transforminal Lumbar Interbody Fusion, a procedure performed under general anesthesia via a posterior minimally invasive approach through the transforminal corridor. Key steps involved dilating the paraspinal musculature unilaterally with a retractor following exposure, subsequently performing pedicle screw insertion, decompression, and interbody cage placement, supplemented by contralateral percutaneous pedicle screw fixation.', 'interventionNames': ['Procedure: modified mini-open transforaminal lumbar interbody fusion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional TLIF surgery group', 'description': 'The traditional Open Transforminal Lumbar Interbody Fusion (TLIF) is a classic spinal surgical procedure. It is characterized by a long midline open incision, which requires extensive subperiosteal dissection and stripping of the paraspinal muscles to expose the bony anatomy. This approach provides a wide, direct surgical field, allowing for pedicle screw placement, neural decompression, and interbody fusion to be performed under direct visualization.', 'interventionNames': ['Procedure: traditional transforaminal lumbar interbody fusion']}], 'interventions': [{'name': 'modified mini-open transforaminal lumbar interbody fusion', 'type': 'PROCEDURE', 'description': 'The modified Mini-Open Transforaminal Lumbar Interbody Fusion (mMO-TLIF) is a hybrid technique that integrates minimally invasive and open concepts. Its core principle involves a limited open exposure on the decompression side for canal decompression and interbody fusion using retractors, while the non-decompression side undergoes pure percutaneous pedicle screw fixation, thereby maximally preserving the paraspinal muscles. This approach effectively balances surgical visualization with tissue preservation, achieving robust internal fixation while significantly reducing muscle injury, intraoperative blood loss, and enhancing surgical efficiency, making it particularly suitable for multi-level fusion.', 'armGroupLabels': ['mMO-TLIF surgery group']}, {'name': 'traditional transforaminal lumbar interbody fusion', 'type': 'PROCEDURE', 'description': 'Traditional Transforaminal Lumbar Interbody Fusion (TLIF) is a classic posterior surgical approach for lumbar pathologies. It utilizes a posterior midline incision with extensive dissection and retraction of paraspinal muscles to achieve adequate exposure, allowing for discectomy, neural decompression, and interbody fusion through a unilateral transforaminal approach, typically supplemented with bilateral pedicle screw instrumentation.\n\nAdvantages: Excellent surgical exposure and large working space facilitating thorough neural decompression and providing reliable spinal stability.\n\nDisadvantages: Extensive dissection of paraspinal soft tissues may lead to postoperative chronic muscle denervation and low back pain; associated with significant intraoperative blood loss and a prolonged recovery period.', 'armGroupLabels': ['Traditional TLIF surgery group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'You Lv', 'role': 'CONTACT', 'email': 'gwykr@outlook.com', 'phone': '+86 18861301627'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "The First People's Hospital of Lianyungang", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}