Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT03451305
Status:
UNKNOWN
Last Update Posted:
2018-03-01
First Post:
2018-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Postrual Reduction With Pillow in Osteoporotic Vertebral Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058866', 'term': 'Osteoporotic Fractures'}, {'id': 'D050815', 'term': 'Fractures, Compression'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'Patients eligible for the study were selected by an independent research assistant. The study was explained, and informed consent was obtained from patients before the surgery. Using a randomization sequence, the patients were assigned to the international or control group. The attending surgeons and patients were blinded before the surgery.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients with single level osteoporotic compression fracture'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2019-05-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-23', 'studyFirstSubmitDate': '2018-02-07', 'studyFirstSubmitQcDate': '2018-02-23', 'lastUpdatePostDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sagittal plane contour', 'timeFrame': '6 months of post-operative follow up', 'description': 'Sagittal plane measurement by measuring the Cobb angle of the injured vertebral on lateral radio-graphs'}], 'secondaryOutcomes': [{'measure': 'Functional outcome', 'timeFrame': '6 months of post-operative follow up', 'description': 'Visual Analogue Scale This is a pain scale, 10 scoes is the worest pain ever. 0 scores is no pain'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Compression fracture, postural reduction, vertebroplasty'], 'conditions': ['Compression Fracture Spine', 'Osteoporosis Fracture']}, 'referencesModule': {'references': [{'pmid': '14563813', 'type': 'BACKGROUND', 'citation': 'Rao RD, Singrakhia MD. Painful osteoporotic vertebral fracture. Pathogenesis, evaluation, and roles of vertebroplasty and kyphoplasty in its management. J Bone Joint Surg Am. 2003 Oct;85(10):2010-22. No abstract available.'}, {'pmid': '24462536', 'type': 'BACKGROUND', 'citation': 'Lee JH, Lee DO, Lee JH, Lee HS. Comparison of radiological and clinical results of balloon kyphoplasty according to anterior height loss in the osteoporotic vertebral fracture. Spine J. 2014 Oct 1;14(10):2281-9. doi: 10.1016/j.spinee.2014.01.028. Epub 2014 Jan 23.'}, {'pmid': '16575333', 'type': 'RESULT', 'citation': 'Chin DK, Kim YS, Cho YE, Shin JJ. Efficacy of postural reduction in osteoporotic vertebral compression fractures followed by percutaneous vertebroplasty. Neurosurgery. 2006 Apr;58(4):695-700; discussion 695-700. doi: 10.1227/01.NEU.0000204313.36531.79.'}]}, 'descriptionModule': {'briefSummary': 'Vertebroplasty in the symptomatic osteoporotic vertebral fracture has become increasingly popular. However, there have been some limitations in restoring the height of the collapsed vertebrae and in preventing the leaking of cement. In the severely collapsed vertebrae of more than two thirds of their original height, vertebroplasty is regarded as a contraindication. We tried postural reduction using a soft pillow under the compressed level. This study was undertaken to investigate the effectiveness of the combination of postural reduction and vertebroplasty for re-expansion and stabilization of the osteoporotic vertebral fractures. single level vertebral compression fracture were treated with postural reduction followed by vertebroplasty. We analyzed the degree of re-expansion according to the onset duration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Single level osteoporotic compression fracture of thoracic and lumbar spine\n\nExclusion Criteria:\n\n* Can't tolerate the postural reduction by pillow\n* Pathological spine fracture caused by tumor, infection.\n* Multiple spine fractures\n* Patient presented with neurological. deficits"}, 'identificationModule': {'nctId': 'NCT03451305', 'briefTitle': 'Postrual Reduction With Pillow in Osteoporotic Vertebral Fracture', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Taipei Veterans General Hospital, Taiwan'}, 'officialTitle': 'Postrual Reduction With Pillow in Osteoporotic Vertebral Fractures: a Randomized, Prospective Study', 'orgStudyIdInfo': {'id': '2017-05-005C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pillow group', 'description': 'Before surgery, with the patient lying in the supine position, a soft pillow was placed under the segment of the collapsed vertebrae, which resulted in a hyperextension position. 12 hours duration suggested from 11:00 pm 1 night before the surgery till next day.', 'interventionNames': ['Other: Pillow']}, {'type': 'NO_INTERVENTION', 'label': 'No pillow group', 'description': 'No intervention was given in this group before surgery.'}], 'interventions': [{'name': 'Pillow', 'type': 'OTHER', 'description': 'A soft pillow was placed under the segment of the collapsed vertebrae, which resulted in a hyperextension position', 'armGroupLabels': ['Pillow group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '112', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Ming-Chau Chang, M.D.', 'role': 'CONTACT', 'email': 'mcchang@vghtpe.gov.tw', 'phone': '886-2-28717557', 'phoneExt': '9'}], 'facility': 'Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Ming-Chau Chang, M.D.', 'role': 'CONTACT', 'email': 'mcchang@vghtpe.gov.tw', 'phone': '886-2-28717557', 'phoneExt': '9'}, {'name': 'Yu-Cheng Yao, M.D.', 'role': 'CONTACT', 'email': 'orthycyao@gmail.com', 'phone': '886-2-28717557', 'phoneExt': '9'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Veterans General Hospital, Taiwan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of orthopedics', 'investigatorFullName': 'vghtpe user', 'investigatorAffiliation': 'Taipei Veterans General Hospital, Taiwan'}}}}