Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:49 AM
Study NCT ID:
NCT07413302
Status:
RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Preoperative Factors Influencing the Outcome of Motor Deficits in Patients Undergoing Lumbar Microdiskectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D018908', 'term': 'Muscle Weakness'}, {'id': 'D010291', 'term': 'Paresis'}, {'id': 'D007405', 'term': 'Intervertebral Disc Displacement'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-09', 'studyFirstSubmitDate': '2026-01-24', 'studyFirstSubmitQcDate': '2026-02-09', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle Strength', 'timeFrame': 'Perioperative', 'description': 'The strength of lower main muscles will be assessed and will be rated according to the Medical Research Council Scale for Muscle Strength. The scale takes values between 0 and 5, with 5 being the best possible (healthy).'}, {'measure': 'Duration of paresis before surgical treatment', 'timeFrame': 'Baseline', 'description': 'Time between the initiation of paresis and surgical treatment measured in days'}], 'secondaryOutcomes': [{'measure': 'Age', 'timeFrame': 'Baseline', 'description': 'The age of participant as measured in years'}, {'measure': 'Obesity', 'timeFrame': 'Baseline', 'description': 'Body Mass Index (BMI) measured as the ratio between the mass measured in kilograms over the square of height measured in meters. There will be two groups of patients: a) with obesity and b) without obesity.'}, {'measure': 'Diabetes Melitus', 'timeFrame': 'Baseline', 'description': 'Participant is diagnosed with diabetes melitus (yes/no)'}, {'measure': 'Hernia location', 'timeFrame': 'Baseline', 'description': 'Categorisation of hernia location based on Magnetic Resonance Imaging (MRI) to a) central, b) subarticular, c) foraminal, and d) extra-foraminal.'}, {'measure': 'Hernia morphology', 'timeFrame': 'Baseline', 'description': 'Hernia morphology will be categorised based on radiology images to a) central, b) extrusion and c) sequestation.'}, {'measure': 'Level of Pain', 'timeFrame': 'Perioperative', 'description': 'The pain level of participants will be measured using the Numeric Rating Scale for Pain which ranges from 0 (no pain) to 10 (worst pain imaginable).'}, {'measure': 'Functionality', 'timeFrame': 'Perioperative', 'description': 'The functionality of participants will be measured using the Oswestry Disability Index (ODI) which consists of 10 questions using a 5-level Likert scale with 0 being the best.'}, {'measure': 'Quality of life assessment', 'timeFrame': 'Perioperative', 'description': 'This outcome will be measured using the EQ-5D-5L questionnaire. It is using 5-Level Likert scale, with 0 being the best. Also, it includes a self-report of health status using a 0 to 100 scale, 100 being best.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['microdiscectomy', 'lumbar disc herniation', 'motor deficit', 'lower limb paresis', 'prognostic factors microdiscectomy', 'disc herniation outcome'], 'conditions': ['Motor Deficits', 'Lumbar Discectomy', 'Muscle Weakness', 'Paresis', 'Lumbar Disc Herniation']}, 'descriptionModule': {'briefSummary': 'Lumbar disc herniations may result in lower limb weakness. In such cases, there is a strong indication for surgical intervention through microdiscectomy. This clinical study aims to investigate preoperative factors that may influence the postoperative outcomes of patients undergoing this procedure.', 'detailedDescription': 'Background: Motor deficits owing to neural compression caused by lumbar disc herniation are a common problem encountered in spine surgery. Microdiscectomy is considered the preferred procedure for the treatment of limb paresis related to a herniated disc. Nevertheless, there is a restricted number of clinical studies in the literature investigating the role of preoperative factors that could influence the postoperative outcome in these patients.\n\nAim: To investigate the prognostic factors determining the outcome in patients with lower limb paresis caused by a herniated lumbar disc subjected to microdiscektomy.\n\nStudy type: Primary clinical research, observational prognostic study. Materials: Patients suffering from a motor deficit due to lumbar disc herniation to undergo lumbar microdiscectomy in three neurosurgical departments.\n\nProtocol: Prospective multicenter study. This research will discover the prognostic value of two primary and five secondary preoperative factors. Primary factors: a) the severity of paresis, b) the duration of paresis. Secondary factors: a) age, b) body mass index, c) diabetes mellitus, d) anatomic location of the herniated disc, e) morphology of the herniated disc.\n\nOutcomes: The key evaluation criterion is the muscle strength of the most severely affected lower limb muscle according to the six-point (0-5) Medical Research Counsil (MRC) Scale for Muscle Strength. After the comparison between the postoperative and preoperative muscle strength, the outcome of paresis will be recorded as: a) full recovery, b) partial recovery or c) no recovery.\n\nSample size: Forty (40) patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients visiting the three recruitment hospitals, all located in North Greece.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients suffering from lower limb paresis (motor deficit) caused by lumbar disk herniation undergoing a single-level microdiskectomy\n* Age (years) \\> 17\n\nExclusion Criteria:\n\n* Age (years) \\< 18\n* Medical history of lumbar spine surgery\n* Absence of limb paresis\n* Motor deficit caused by other than disk herniation aetiologies\n* Reoperation within 6 months after microdiskectomy\n* Microdiskectomy at more than one level\n* Cauda equina syndrome\n* Peripheral neuropathy'}, 'identificationModule': {'nctId': 'NCT07413302', 'briefTitle': 'Investigation of Preoperative Factors Influencing the Outcome of Motor Deficits in Patients Undergoing Lumbar Microdiskectomy', 'organization': {'class': 'OTHER', 'fullName': 'Aristotle University Of Thessaloniki'}, 'officialTitle': 'Investigation of Preoperative Factors Influencing the Outcome of Motor Deficits in Patients Undergoing Lumbar Microdiskectomy', 'orgStudyIdInfo': {'id': '292/2024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with limb paresis due to lumbar disk herniation undergoing microdiskectomy', 'description': 'Patients suffering from motor deficit because of lumbar disk herniation scheduled to undergo single-level microdiskectomy.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '65500', 'city': 'Kavala', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Eva Kanelli', 'role': 'CONTACT', 'email': 'pk@kavalahospital.gr', 'phone': '+302513501545'}, {'name': 'Panagiotis Sarlis, MSc, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Stavros Stamatiou', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Georgios Kalostos', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'General Hospital of Kavala', 'geoPoint': {'lat': 40.93959, 'lon': 24.40687}}, {'zip': '54642', 'city': 'Thessaloniki', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Dimitra Emmanouilidou', 'role': 'CONTACT', 'email': 'qre@ippokratio.gr', 'phone': '+302313312690'}, {'name': 'Ioannis Magras, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Parmenion Tsitsopoulos, Professor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Elias Antoniades', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Emmanouil Kenanoglou', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Panagiotis Kartsidis', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hippokration General Hospital', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '57001', 'city': 'Thessaloniki', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Olymbia Semoglou', 'role': 'CONTACT', 'email': 'scientific.director@interbalkan-hosp.gr', 'phone': '+302310400342'}, {'name': 'Alkinoos Athanasiou', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Georgios Psychidis', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Georgios Antonoglou', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'European Interbalkan Medical Center', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}], 'centralContacts': [{'name': 'Panagiotis Sarlis', 'role': 'CONTACT', 'email': 'psarlis@gapps.auth.gr', 'phone': '+302513501449'}], 'overallOfficials': [{'name': 'Panagiotis Sarlis', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aristotle University Of Thessaloniki'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aristotle University Of Thessaloniki', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hippocration General Hospital', 'class': 'OTHER'}, {'name': 'General Hospital of Kavala', 'class': 'OTHER'}, {'name': 'European Interbalkan Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}