Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2026-02-22 @ 6:44 PM
Study NCT ID:
NCT01988259
Status:
UNKNOWN
Last Update Posted:
2015-05-22
First Post:
2013-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Head-neck Coordination Analysis After Minimally Invasive Surgery in the Dorsal Cervical Spine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D065406', 'term': 'Laminoplasty'}, {'id': 'D059526', 'term': 'Foraminotomy'}], 'ancestors': [{'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'lastUpdateSubmitDate': '2015-05-21', 'studyFirstSubmitDate': '2013-11-13', 'studyFirstSubmitQcDate': '2013-11-13', 'lastUpdatePostDateStruct': {'date': '2015-05-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance of head-neck-coordination after surgery of the dorsal cervical spine', 'timeFrame': 'one year', 'description': 'The primary outcomes of this study are the motor control performance measures assessed using force and position controlled tasks. In addition to motor control performance, secondary outcome measures of patient-oriented outcome measures (e.g. pain, disability, etc.) will be collected.\n\nPerformance measures will consist of the following tasks:\n\n* Head-Neck Position Tracking - Rotation and Flexion/Extension\n* Head-Neck Force Tracking - Flexion, Extension and Lateral Bending Left/Right\n\nDuring the tracking task, a time-varying target (input signal) will be displayed. The participant will be asked to track the specified target by controlling his/her head-neck angle (position tracking) or moment (force tracking). The head position or force during these trials will represent the output signal for the motor control system. These signals will be collected and analyzed in the time and frequency domain to assess error in head-neck motor control.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Multilevel Cervical Spinal Stenosis', 'Single Brachial Radiculopathy']}, 'descriptionModule': {'briefSummary': "To proof patients' benefit of minimally invasive surgery in the dorsal cervical spine an apparatus to examine head-neck-coordination was constructed.\n\nTwo different surgical techniques will be compared:\n\nLaminoplasty: open approach vs minimally invasive surgery (MIS)-approach; Foraminotomy: open approach vs MIS-approach. Each patient will be tested before surgery, postoperative as well as 3 and 12 month follow-up.\n\nHypothesis is that patients after MIS-approaches perform better in their head-neck-coordination as patients with open approaches."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* radicular or myelopathic compression syndrome in the cervical spine\n\nExclusion Criteria:\n\n* neurological diseases with influence on the neuromuscular function\n* previous surgery on the cervical spine'}, 'identificationModule': {'nctId': 'NCT01988259', 'acronym': 'MISDCS', 'briefTitle': 'Head-neck Coordination Analysis After Minimally Invasive Surgery in the Dorsal Cervical Spine', 'organization': {'class': 'OTHER', 'fullName': 'Schoen Klinik Hamburg Eilbek'}, 'officialTitle': 'Comparison of Open vs Minimally Invasive Dorsal Approaches for Foraminotomy and Laminoplasty in the Cervical Spine Through Performance of Head-neck-coordination Analysis', 'orgStudyIdInfo': {'id': 'MISDCS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bilateral approach for laminoplasty', 'description': 'Open approach for laminoplasty', 'interventionNames': ['Procedure: Bilateral approach for Laminoplasty']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Unilateral approach for laminoplasty', 'description': 'Minimally invasive approach for laminoplasty', 'interventionNames': ['Procedure: Unilateral approach for laminoplasty']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Subperiosteal approach for foraminotomy', 'description': 'Open approach for foraminotomy', 'interventionNames': ['Procedure: Subperiosteal approach for foraminotomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Transmuscular approach for foraminotomy', 'description': 'Minimally invasive approach for foraminotomy', 'interventionNames': ['Procedure: Transmuscular approach for foraminotomy']}], 'interventions': [{'name': 'Bilateral approach for Laminoplasty', 'type': 'PROCEDURE', 'description': 'Open bilateral approach for laminoplasty in multilevel cervical spinal stenosis', 'armGroupLabels': ['Bilateral approach for laminoplasty']}, {'name': 'Unilateral approach for laminoplasty', 'type': 'PROCEDURE', 'description': 'Unilateral minimally invasive approach for laminoplasty in multilevel cervical spinal stenosis.', 'armGroupLabels': ['Unilateral approach for laminoplasty']}, {'name': 'Subperiosteal approach for foraminotomy', 'type': 'PROCEDURE', 'description': 'Unilateral subperiostal approach for single level foraminotomy', 'armGroupLabels': ['Subperiosteal approach for foraminotomy']}, {'name': 'Transmuscular approach for foraminotomy', 'type': 'PROCEDURE', 'description': 'Unilateral transmuscular approach for single level foraminotomy', 'armGroupLabels': ['Transmuscular approach for foraminotomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22081', 'city': 'Hamburg', 'state': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ralph Kothe, MD', 'role': 'CONTACT', 'email': 'rkothe@Schoen-Kliniken.de', 'phone': '0049 40 2092', 'phoneExt': '7001'}, {'name': 'Alexander Gude, MD', 'role': 'CONTACT', 'email': 'agude@Schoen-Kliniken.de', 'phone': '0049 40 2092', 'phoneExt': '7068'}, {'name': 'Ralph Kothe, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Schoen Klinik Hamburg Eilbek', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'centralContacts': [{'name': 'Ralph Kothe, MD', 'role': 'CONTACT', 'email': 'rkothe@Schoen-Kliniken.de', 'phone': '0049 40 2092', 'phoneExt': '7001'}, {'name': 'Alexander Gude, MD', 'role': 'CONTACT', 'email': 'agude@Schoen-Kliniken.de', 'phone': '0049 40 2092', 'phoneExt': '7068'}], 'overallOfficials': [{'name': 'Ralph Kothe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Spine Unit @ Schoen Klinik Hamburg Eilbek'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Schoen Klinik Hamburg Eilbek', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jacek Cholewicki PhD', 'class': 'UNKNOWN'}, {'name': 'MSU Center for Orthopedic Research', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Spine Surgery', 'investigatorFullName': 'Ralph Kothe, PD Dr. med.', 'investigatorAffiliation': 'Schoen Klinik Hamburg Eilbek'}}}}