Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-02-21 @ 10:38 PM
Study NCT ID:
NCT02564705
Status:
COMPLETED
Last Update Posted:
2023-05-19
First Post:
2015-09-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study of Anterior vs. Posterior Surgical Treatment for Lumbar Isthmic Spondylolisthesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 177}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-05-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-17', 'studyFirstSubmitDate': '2015-09-29', 'studyFirstSubmitQcDate': '2015-09-29', 'lastUpdatePostDateStruct': {'date': '2023-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-05-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Oswestry Disability Index Score v2.1a', 'timeFrame': 'between pre-operative and 730 days (24 months)'}], 'secondaryOutcomes': [{'measure': 'Change in Numeric Pain Rating Scale (Pain NRS) for low back pain', 'timeFrame': 'between pre-operative and 730 days (24 months)'}, {'measure': 'Change in EQ-5D-3L health utility index', 'timeFrame': 'between pre-operative and 730 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Isthmic Spondylolisthesis']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare outcomes and cost-effectiveness of anterior versus posterior surgical treatment for lumbar Isthmic Spondylolisthesis. The primary objective is to compare treatment effectiveness in terms of functional outcomes as measured by Oswestry Disability Index (ODI) v2.1a and to compare safety outcomes measured by treatment-related adverse events. Secondary objectives are to compare treatments in terms of differences in pain, quality of life, health utilities, and need for re-operation. Finally, a cost-effectiveness analysis will be performed. This analysis will take the form of cost-effectiveness if there is a difference in treatment effects or cost-minimization if there is no difference in treatment efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Isthmic spondylolisthesis (IS)', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 18 to 80 years, inclusive\n* Grade I, II or III (less than 75% slip of the cephalad vertebra compared to the caudal vertebra) isthmic spondylolisthesis at single level between L4 and S1\n* Unresponsive to a minimum of 3 months of non-surgical treatment\n* No previous surgical treatment for isthmic spondylolisthesis\n* Patients who are medically suitable for surgical management\n* Patients who have consented for surgical treatment\n* Willing and able to comply with the Investigational Protocol (IP)\n* Informed Consent Form (ICF) signed by patient\n\nExclusion Criteria:\n\n* Any previous lumbar spine surgery\n* Patient has significant scoliosis (Cobb angle is greater than 25 degrees)\n* Subject has cauda equina syndrome defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder (bladder retention or incontinence) dysfunction\n* Subject is pregnant or of child-bearing potential and not currently on adequate birth control method\n* Active infection at the surgical site\n* Recent history (less than 1 year) of chemical substance dependency or significant psychosocial disturbance that may impact the outcome or study participation, in the opinion of the Investigator\n* Pre-existent neurologic or mental disorder which would preclude accurate evaluation and follow-up (i.e. Alzheimer's disease, Parkinson's disease, unstable psychiatric disorder with hallucinations and/or delusions or schizophrenia\n* Participation in another clinical trial of drug or device within the past 30 days that could influence the outcomes of this study\n* Is a prisoner\n* Acquired immune deficiency syndrome (AIDS) or AIDS-related complex\n* Active malignancy or history of invasive malignancy within the last five years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitely treated; patients with carcinoma in situ of the uterine cervix treated definitely more than 1 year prior to enrollment may enter the study"}, 'identificationModule': {'nctId': 'NCT02564705', 'acronym': 'I-Spondy', 'briefTitle': 'Comparative Study of Anterior vs. Posterior Surgical Treatment for Lumbar Isthmic Spondylolisthesis', 'organization': {'class': 'NETWORK', 'fullName': 'AOSpine North America Research Network'}, 'officialTitle': 'A Multi-Center, Prospective, Comparative Study of Anterior vs. Posterior Surgical Treatment for Lumbar Isthmic Spondylolisthesis', 'orgStudyIdInfo': {'id': 'SPN-14-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'anterior cohort', 'description': 'Anterior Lumbar Interbody Fusion (ALIF)', 'interventionNames': ['Procedure: Anterior Lumbar Interbody Fusion (ALIF)']}, {'label': 'posterior cohort', 'description': '* Posterolateral Fusion (PLF)\n* Posterior Lumbar Interbody Fusion (PLIF)\n* Transforaminal Lumbar Interbody Fusion (TLIF)', 'interventionNames': ['Procedure: Posterior Fusion']}], 'interventions': [{'name': 'Anterior Lumbar Interbody Fusion (ALIF)', 'type': 'PROCEDURE', 'armGroupLabels': ['anterior cohort']}, {'name': 'Posterior Fusion', 'type': 'PROCEDURE', 'description': '* Posterolateral Fusion (PLF)\n* Posterior Lumbar Interbody Fusion (PLIF)\n* Transforaminal Lumbar Interbody Fusion (TLIF)', 'armGroupLabels': ['posterior cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143-0122', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '61801', 'city': 'Urbana', 'state': 'Illinois', 'country': 'United States', 'facility': 'Carle Foundation Hospital', 'geoPoint': {'lat': 40.11059, 'lon': -88.20727}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kansas University Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '65212', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University / Rothman Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '84108', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah Department of Orthopedics', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia Department of Neurosurgery', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'M5T 2S8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Western Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AOSpine North America Research Network', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}