Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-31 @ 2:15 PM
Study NCT ID:
NCT05140733
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2021-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcomes of Patients With Foraminal Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000013', 'term': 'Congenital Abnormalities'}], 'ancestors': [{'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-13', 'studyFirstSubmitDate': '2021-08-22', 'studyFirstSubmitQcDate': '2021-11-21', 'lastUpdatePostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cost-effectiveness', 'timeFrame': 'preoperation', 'description': 'cost to increased one quality adjusted life year (QALY) after surgical treatment'}, {'measure': 'Cost-effectiveness', 'timeFrame': 'postoperative 6 months', 'description': 'cost to increased one quality adjusted life year (QALY) after surgical treatment'}, {'measure': 'Cost-effectiveness', 'timeFrame': 'postoperative 1 year', 'description': 'cost to increased one quality adjusted life year (QALY) after surgical treatment'}, {'measure': 'Cost-effectiveness', 'timeFrame': 'postoperative 2 years', 'description': 'cost to increased one quality adjusted life year (QALY) after surgical treatment'}], 'secondaryOutcomes': [{'measure': 'Oswestry disability index (ODI)', 'timeFrame': 'preoperation', 'description': 'ODI was recorded at preoperation, postoperative 6 months, 1 year and 2 years.'}, {'measure': 'Oswestry disability index (ODI)', 'timeFrame': 'postoperative 6 months', 'description': 'ODI was recorded at preoperation, postoperative 6 months, 1 year and 2 years.'}, {'measure': 'Oswestry disability index (ODI)', 'timeFrame': 'postoperative 1 year', 'description': 'ODI was recorded at preoperation, postoperative 6 months, 1 year and 2 years.'}, {'measure': 'Oswestry disability index (ODI)', 'timeFrame': 'postoperative 2 years', 'description': 'ODI was recorded at preoperation, postoperative 6 months, 1 year and 2 years.'}, {'measure': 'Numeric rating scale(NRS) of pain on back (NRS-B) and legs (NRS-L)', 'timeFrame': 'preoperation', 'description': "NRS-B and NRS-L were recorded at preoperation, postoperative 6 months, 1 year and 2 years.\n\nNumeric rating scale (NRS)\n\n: Scale from 0 to 10. Zero means there's no pain and 10 means the maximum pain."}, {'measure': 'Numeric rating scale(NRS) of pain on back (NRS-B) and legs (NRS-L)', 'timeFrame': 'postoperative 6 months', 'description': "NRS-B and NRS-L were recorded at preoperation, postoperative 6 months, 1 year and 2 years.\n\nNumeric rating scale (NRS)\n\n: Scale from 0 to 10. Zero means there's no pain and 10 means the maximum pain."}, {'measure': 'Numeric rating scale(NRS) of pain on back (NRS-B) and legs (NRS-L)', 'timeFrame': 'postoperative 1 year', 'description': "NRS-B and NRS-L were recorded at preoperation, postoperative 6 months, 1 year and 2 years.\n\nNumeric rating scale (NRS)\n\n: Scale from 0 to 10. Zero means there's no pain and 10 means the maximum pain."}, {'measure': 'Numeric rating scale(NRS) of pain on back (NRS-B) and legs (NRS-L)', 'timeFrame': 'postoperative 2 years.', 'description': "NRS-B and NRS-L were recorded at preoperation, postoperative 6 months, 1 year and 2 years.\n\nNumeric rating scale (NRS)\n\n: Scale from 0 to 10. Zero means there's no pain and 10 means the maximum pain."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cost-effectiveness', 'surgery', 'deformity'], 'conditions': ['Lumbar Foraminal Stenosis']}, 'descriptionModule': {'briefSummary': 'The present study was to see the effect of minimally invasive neural foraminotomy for lumbar foraminal stenosis with unilateral radicular pain. Traditionally, fusion was was done for the patients, but recent development enable surgeon to decompress neural foramen without rigid spinal fusion. Although, clinical effect of neural foraminotomy may have limitation in attaining a comparable result to fusion surgery, a cost-effective analysis may reveal a result in a different perspective. In this regard, we designed a prospective cohort study to see the cost-effectiveness of neural foraminotomy compared to fusion surgery.', 'detailedDescription': "Control: 1-2 levels fusion surgery Intervention: neural foraminotomy\n\nInclusion patients between 40 - 100 years. No improvement despite nonsurgical treatment for more than 3 months. No history of lumbar fusion surgery Single or double-level lumbar foraminal stenosis with corresponding leg pain\n\nExclusion Severe neurological deficit (motor grade less than Grade III) Combined inflammatory joint disease Combined neurodegenerative disease such as Parkinson's disease or dementia Combined cancer, traumatic fracture marked spinal deformity (C7 sagittal vertical axis \\> 10cm)\n\nSurgery and follow-up Patients underwent foraminotomy and visits outpatient clinical at determined time points (postoperative month 1, 6, 12 and 24 months) Their clinical outcomes were recorded at each visit. Their medical costs were retrieved at the time of analysis by using hospital records.\n\nStatistical analysis means: T-test"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '26 patients in each foraminotomy and fusion group.', 'eligibilityCriteria': "Inclusion:\n\n* patients between 40 - 100 years.\n* No improvement despite nonsurgical treatment for more than 3 months.\n* No history of lumbar fusion surgery.\n* Single or double-level lumbar foraminal stenosis with corresponding leg pain\n\nExclusion:\n\n* Severe neurological deficit (motor grade less than Grade III)\n* Combined inflammatory joint disease\n* Combined neurodegenerative disease such as Parkinson's disease or dementia \\* Combined cancer, traumatic fracture\n* Marked spinal deformity (C7 sagittal vertical axis \\> 10cm)"}, 'identificationModule': {'nctId': 'NCT05140733', 'briefTitle': 'Outcomes of Patients With Foraminal Stenosis', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Cost-effectiveness Analysis Between Lumbar Foraminotomy and Lumbar Single or Double Levels Fusion Surgery in Patients With Foraminal Stenosis', 'orgStudyIdInfo': {'id': 'Foraminotomy'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fusion', 'description': '1 or 2 levels fusion surgery', 'interventionNames': ['Procedure: Fusion surgery']}, {'label': 'Foraminotomy', 'description': '1 or 2 levels lumbar foraminotomy', 'interventionNames': ['Procedure: lumbar foraminal decompression']}], 'interventions': [{'name': 'lumbar foraminal decompression', 'type': 'PROCEDURE', 'description': 'lumbar foraminal decompression with endoscopic instruments.', 'armGroupLabels': ['Foraminotomy']}, {'name': 'Fusion surgery', 'type': 'PROCEDURE', 'description': 'Fusion surgery for patients with foraminal stenosis', 'armGroupLabels': ['Fusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'state': 'Korea', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'after publication of study results.', 'ipdSharing': 'YES', 'description': 'I am willing to share all data after publication.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Chi Heon Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}