Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-04 @ 4:53 AM
Study NCT ID:
NCT04886557
Status:
COMPLETED
Last Update Posted:
2021-05-14
First Post:
2021-05-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Image Analysis of Degenerative Lumbar Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013168', 'term': 'Spondylolisthesis'}], 'ancestors': [{'id': 'D013169', 'term': 'Spondylolysis'}, {'id': 'D055009', 'term': 'Spondylosis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-12', 'studyFirstSubmitDate': '2021-05-12', 'studyFirstSubmitQcDate': '2021-05-12', 'lastUpdatePostDateStruct': {'date': '2021-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Range of motion', 'timeFrame': 'All patients completed the follow-up assessment at postoperative 1-, 2-, 3-, 6-, 12-, and 24-months.', 'description': 'The ROM change at index surgical level, supra-index level, and whole lumbar spine in degenerative lumbar diseased patients received dynesys dynamic instrumentation'}], 'secondaryOutcomes': [{'measure': 'Screw loosening', 'timeFrame': 'All patients completed the follow-up assessment at postoperative 1-, 2-, 3-, 6-, 12-, and 24-months.', 'description': 'Radiographic screw-loosening was defined as presence of a halo or double-halo sign on plain x-ray films'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dynesys dynamic stabilization, range of motion'], 'conditions': ['Lumbar Spondylolisthesis']}, 'referencesModule': {'references': [{'pmid': '26335675', 'type': 'RESULT', 'citation': 'St-Pierre GH, Jack A, Siddiqui MM, Henderson RL, Nataraj A. Nonfusion Does Not Prevent Adjacent Segment Disease: Dynesys Long-term Outcomes With Minimum Five-year Follow-up. Spine (Phila Pa 1976). 2016 Feb;41(3):265-73. doi: 10.1097/BRS.0000000000001158.'}]}, 'descriptionModule': {'briefSummary': 'The Dynesys dynamic stabilization (DDS) system is considered a motion-preserving device. However, studies addressing the change in the range of motion (ROM) are limited. Therefore, this study aimed to investigate the factors influencing ROM change at the index surgical level, supra-index level, and whole lumbar spine, in addition to the association between ROM preservation and the incidence of screw-loosening.', 'detailedDescription': 'Decompression with instrumented fusion is an effective surgical intervention for lumbar degenerative spondylolisthesis with spinal stenosis. However, the range of motion (ROM) decreased at the index surgical level may lead to an increased ROM at the non-surgical level, increase biomechanical stress at the transitional adjacent segment, and lead to adjacent segment degeneration (ASD) .\n\nThe Dynesys dynamic stabilization (DDS) system is a pedicle screw-based, motion-preserving, and non-fusion stabilization developed as an alternative to the rigid instrumented fusion for degenerative spondylolisthesis. The aim of the DDS is to maintain segmental motion at index levels and to reduce the incidence of ASD. However, the actual impact of ROM has remained elusive. Prior studies have reported an average ROM loss of 1.1º to 17.3º 7 at index surgical level at an average of 24 months follow-up.\n\nThe change of ROM at index surgical, supra-index, and whole lumbar spine following DDS remains unclear. This study aims to investigate the factors influencing the ROM change at index surgical level, supra-index level, and whole lumbar spine, and the association between ROM preservation and the incidence of screw-loosening.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with degenerative spondylolisthesis over L4-L5 who failed to respond to conservative treatment for at least 6 months and received Dynesys instrumentation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients\n* Diagnosed with degenerative spondylolisthesis over L4-L5\n* Received DDS\n* Received a minimum of 2-year follow-up were reviewed.\n\nExclusion Criteria:\n\n* presence of degenerative scoliosis or spinal deformity,\n* prior spine surgery,\n* lost to follow-up, or\n* failure to complete the questionnaires or radiographic examinations.'}, 'identificationModule': {'nctId': 'NCT04886557', 'briefTitle': 'Retrospective Image Analysis of Degenerative Lumbar Disease Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Taipei Veterans General Hospital, Taiwan'}, 'officialTitle': 'Retrospective Image Analysis of Degenerative Lumbar Disease Patients', 'orgStudyIdInfo': {'id': '2017-10-008BC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'DDS fixation', 'description': 'Adult patients with degenerative spondylolisthesis over L4-L5 received DDS with a minimum of 2-year follow-up were reviewed. Surgical indications were patients who failed to respond to conservative treatment for at least 6 months. The exclusion criteria were: (1) presence of degenerative scoliosis or spinal deformity, (2) prior spine surgery, (3) lost to follow-up, or (4) failure to complete the questionnaires or radiographic examinations.', 'interventionNames': ['Procedure: L4-L5 decompression and dynamic instrumentation']}], 'interventions': [{'name': 'L4-L5 decompression and dynamic instrumentation', 'type': 'PROCEDURE', 'description': 'All surgeries were performed by a senior surgeon using a traditional midline approach. Stability-preserving lumbar decompression with facet joint undercutting was performed to preserve the facet joints as much as possible. In cases of severe stenosis, a bilateral partial facetectomy (\\< 25%) was performed for adequate decompression. Posterior tension of the supra- and inter-spinous ligaments was preserved at the most cranial level. Patients were encouraged to ambulate after drain removal and wear a soft lumbar orthosis for at least 3 months after the operation.', 'armGroupLabels': ['DDS fixation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '112', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Dep. of Orthopedics and Traumatology, Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Veterans General Hospital, Taiwan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}