Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2026-02-22 @ 4:10 AM
Study NCT ID:
NCT03701269
Status:
UNKNOWN
Last Update Posted:
2018-10-10
First Post:
2018-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Surgical Outcomes of Scaphoid Proximal Pole Fracture Nonunion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2019-08-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-07', 'studyFirstSubmitDate': '2018-09-26', 'studyFirstSubmitQcDate': '2018-10-07', 'lastUpdatePostDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disabilities of the Arm, Shoulder, and Hand (DASH) score', 'timeFrame': 'averaged 2 years', 'description': '30-item disability/symptom scale, scored 0 (no disability) to 100'}], 'secondaryOutcomes': [{'measure': 'Radiographic examination', 'timeFrame': 'averaged 2 years', 'description': 'The union was defined as trabecular bridging across the fracture site'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fracture'], 'conditions': ['Orthopedic']}, 'descriptionModule': {'briefSummary': 'The treatment for scaphoid proximal pole nonunion remains challenging due to the poor vascularity in the proximal pole fragment, associated SL injury and the technique of fixation. Vascularized bone grafts and non-vascularized iliac bone graft have been used in patients with scaphoid proximal pole nonunion, but the indication has not been well clarified. Alternatively, we have been treating such patients with vascularized bone graft , or non-vascularized bone graft with screw or k-wire fixation with considerable success. The purpose of this study is to evaluate and analyze retrospectively the surgical efficacy of our procedure.', 'detailedDescription': 'Scaphoid nonunion are common and operative treatment with bone graft was reported to have good result. However, the treatment for proximal pole nonunion remains controversial. There are some patterns of pathoanatomy combined with scaphoid fracture, like SL ligament tears, which could not be easily identified or treated initially. The proximal pole nonunion was near SL joint. Therefore, proximal pole nonunion may result in DISI instability. Furthermore, proximal pole nonunion was identified as a poor prognostic factor in scaphoid nonunion.\n\nIn the past 10 years, we have some different technique, like VBG, arthroscopic bone graft to achieve good results. Some studies revealed that significantly better SL stability was achieved with ARASL. We also used ARASL with BG to improve proximal pole union. However, it is not clear which method would be appropriate for proximal pole nonunion. We retrospectively investigated the functional outcome and radiological results after at least 2-year follow-up to clarify the surgical efficacy of these procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Using arthroscopic or open fixation combined with bone graft surgery for proximal pole scaphoid nonunion', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) chronic nonunion (wrist pain for more than 3 months after injury) as defined by preoperative radiographs; and (2) combined positive SL instability measured by intraoperative arthroscopy exam test; (3) Grade I SNAC.\n\nExclusion Criteria:\n\n* (1) skeletally immature patients; (2) previous wrist trauma or surgery.'}, 'identificationModule': {'nctId': 'NCT03701269', 'briefTitle': 'Long-term Surgical Outcomes of Scaphoid Proximal Pole Fracture Nonunion', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Taipei Veterans General Hospital, Taiwan'}, 'officialTitle': 'Long-term Radiographic and Clinic Surgical Outcomes of Scaphoid Proximal Pole Fracture Nonunion', 'orgStudyIdInfo': {'id': '2018-08-010AC'}}, 'contactsLocationsModule': {'locations': [{'zip': '112', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Jung-Pan Wang, M.D.,ph.D', 'role': 'CONTACT', 'email': 'jpwang801@gmail.com', 'phone': '0228712121', 'phoneExt': '1125'}], 'facility': 'Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Jung-Pan Wang, M.D.,ph.D', 'role': 'CONTACT', 'email': 'jpwang801@gmail.com', 'phone': '02-28757557', 'phoneExt': '1125'}], 'overallOfficials': [{'name': 'Jung-Pan Wang, M.D.,ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taipei Veterans General Hospital, Taiwan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Veterans General Hospital, Taiwan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}