Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-25 @ 9:09 PM
Study NCT ID:
NCT03511456
Status:
UNKNOWN
Last Update Posted:
2021-02-08
First Post:
2018-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Effect and Safety Observation on PELD Technique for Extraforaminal Disc Herniation at L5/S1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012585', 'term': 'Sciatica'}], 'ancestors': [{'id': 'D020426', 'term': 'Sciatic Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2022-03-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-04', 'studyFirstSubmitDate': '2018-03-28', 'studyFirstSubmitQcDate': '2018-04-18', 'lastUpdatePostDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Physical functional ability', 'timeFrame': 'The change of physical functional ability before (1 day before operation) and post operation (2 days, 1 month and 3 months after operation).', 'description': 'The life quality specially associated with LDP is evaluated by the Oswestry Disability Index (ODI), an index derived from the Oswestry Low Back Pain Questionnaire.The self-completed questionnaire contains ten topics including intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Patients choose 6 statements describing different potential scenarios in each topic. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.'}], 'primaryOutcomes': [{'measure': 'Pain score', 'timeFrame': 'The change of leg/waist pain before (1 day before operation) and post operation (2 days, 1 month and 3 months after operation).', 'description': 'Pain evaluated by Visual Analogue Scale system. Using a scale ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" and the "agonizing pain" according to the patient\'s mark, providing a range of scores from 0-10. A higher score means intensifier pain. The effects of operation is based on the different VAS scores evaluated by pre- or post- surgical patients who described their pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-1), mild pain(2-5), moderate pain (6-8 mm), and severe pain (9-10).'}], 'secondaryOutcomes': [{'measure': 'Life quality', 'timeFrame': 'The change of life quality before (1 day before operation) and post operation (2 days, 1 month and 3 months after operation).', 'description': 'SF-36(The Short Form (36) Health Survey), a 36-item, patient-reported survey of patient health will be used for life quality evaluation. it consists of eight scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health). The lower the score the more disability. The higher the score the less disability. The scores are compared pre- and post-operation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['leg pain', 'waist pain', 'life quality'], 'conditions': ['Neuralgia, Sciatic']}, 'descriptionModule': {'briefSummary': "43% or so of far lateral lumbar disc herniation (FLLDH) occurred at L5/S1, however, the surgical treatment is still quite challenging. We conducted a modified PELD technique that enable us to remove the extraforaminal herniated disc at L5/S1, through the anatomical space surrounded by transverse process, facet joint and sacrum (TFS space). This study is to this technique's effect and safety in a one year follow-up.", 'detailedDescription': '30 cases diagnosed as extraforaminal disc herniation at the segment of Lumbar 5 / sacrum 1 (L5/S1) will be recruited in this investigation. All the patients will receive PELD operation following the strict procedure that penetrating through the TFS space. The pain score (VAS), physical ability (ODI score) and life quality (SF-36） will be evaluated one day before surgery and 2 days, 1 month and 3 months after the surgery. Any side effects such as infection, nerve damage, main blood vessel injury will be recorded.\n\nThe operation procedure must follow the following steps:\n\n1. The patient was positioned prone.\n2. The skin entry point was determined using axial MRI or CT images\n3. During operation, with anterior posterior view of fluoroscopy, the longitudinal midline of lumbar spine on the skin (Line C), the line right across L5/S1 space (Line A) was marked on the skin. With lateral view, the line right across L5/S1 space was also marked on skin (Line B). The line A and B should be crossed. The final entry point on skin was on the Line A and away from midline with the distance measured on axial MRI or CT images as described above.\n4. Local infiltration with 1% Lidocaine was applied to skin and deep fascia on the penetration path. The introduction of long 20G needles could be performed with continuous or intermittent fluoroscopy. The needle traveled through TFS space. Generally, the position just above S1 superior endplate has enough safe space from the existing nerve root that might be pushed downward by the protruded discs, so it is usually the target for needle puncture.\n\n Discography was strongly recommended to confirm diagnosis and distinguish the protruded disc from the surrounding soft tissue.\n5. The following steps were performed as usual: the needle was replaced by a guide wire; a 9 mm incision was made in the skin at the entry site; a tapered cannulated dilator was inserted along the guide wire; and finally a beveled round working cannula of 8.0 mm in outer diameter was inserted, with the beveled tip touching the endplate of S1 and leaning against superior articular process of S1. If the TFS space is not big enough for working cannula, manual bone drills with blunt tip could be used to enlarge it.\n\nSoft tissue including fat tissue, muscle and fibers of ligaments were pushed cephalad until the blue stained herniated disc was visible. Then the disc was removed. An absorbable gelatin sponge was impacted via the working cannula for hemostasis. A sterile dressing was applied with a one-point suture.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients, diagnosed as extraforaminal lumbar disc herniation at L5/S1, and received the operation of percutaneous endoscopic lumbar discectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients suffered with extraforaminal lumbar disc herniation at L5/S1\n* Patients received percutaneous endoscopic lumbar discectomy\n\nExclusion Criteria:\n\n* The diagnosis is not comply with the FLLDH\n* patients not choose PELD operation\n* patients unwilling to accept regular followup'}, 'identificationModule': {'nctId': 'NCT03511456', 'briefTitle': 'An Effect and Safety Observation on PELD Technique for Extraforaminal Disc Herniation at L5/S1', 'organization': {'class': 'OTHER', 'fullName': 'Nanfang Hospital, Southern Medical University'}, 'officialTitle': 'An Effect and Safety Investigation on Percutaneous Endoscopic Lumbar Discectomy Technique to Remove Extraforaminal Disc Herniation at L5/S1 Segment Through 5th Transverse Process-facet Joint-sacrum Space', 'orgStudyIdInfo': {'id': 'NFEC-2018-022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'FLLDH-PELD', 'description': 'Extraforaminal LDH patients received PELD operation', 'interventionNames': ['Procedure: PELD operation']}], 'interventions': [{'name': 'PELD operation', 'type': 'PROCEDURE', 'description': 'Under local anesthesia, the introduction of 20G needles could be performed with fluoroscopy. After the needle traveled through TFS space, extremely care was needed to avoid nerve root injury.\n\nDiscography was recommended. The following steps were performed as usual: the needle was replaced by a guide wire; a 9 mm incision was made in the skin; a tapered cannulated dilator was inserted along the guide wire; and finally a working cannula was inserted.\n\nThe remove of disc was performed carefully under endoscope. The first step was to locate the annulus fibrosis of L5/S1 disc, then by using nerve dissector and bipolar elliquence, soft tissue including fat tissue, muscle and fibers of ligaments were pushed cephalad until the blue stained herniated disc was visible and removed.', 'armGroupLabels': ['FLLDH-PELD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoliang Wu, MD', 'role': 'CONTACT'}], 'facility': 'Nanfang Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Dehong Yang, MD, PhD', 'role': 'CONTACT', 'email': 'drmyang@yahoo.com', 'phone': '0118618620087638'}, {'name': 'Xiaoliang Wu, MD', 'role': 'CONTACT', 'email': 'Kennymd@126.com', 'phone': '0118613226689489'}], 'overallOfficials': [{'name': 'Dehong Yang, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanfang Hospital, Southern Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}