Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT00738127
Status:
COMPLETED
Last Update Posted:
2008-08-20
First Post:
2008-08-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety Study of Surgical Technique to Treat Acute Dorsal Trans-Scaphoid Perilunate Dislocations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000070799', 'term': 'Open Fracture Reduction'}, {'id': 'D005593', 'term': 'Fracture Fixation, Internal'}, {'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D005592', 'term': 'Fracture Fixation'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 801}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1992-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2004-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-08-19', 'studyFirstSubmitDate': '2008-08-15', 'studyFirstSubmitQcDate': '2008-08-19', 'lastUpdatePostDateStruct': {'date': '2008-08-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In group I was more easily and quickly to perform. It allows early postoperative excises and results better functional wrist range of motion.', 'timeFrame': '1992-2004'}], 'secondaryOutcomes': [{'measure': 'Both groups had satisfactory results with regard to their pain relief, sufficient grip strength and union of scaphoid fracture.', 'timeFrame': '1992-2004'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acute trans-scaphoid perilunate dislocations', 'Open reduction and internal fixation', 'Kirschner-wire', 'Range of motion'], 'conditions': ['Operative Time', 'Grip Strength', 'Pain', 'Functional Status']}, 'referencesModule': {'references': [{'pmid': '6386257', 'type': 'BACKGROUND', 'citation': 'Moneim MS, Hofammann KE 3rd, Omer GE. Transscaphoid perilunate fracture-dislocation. Result of open reduction and pin fixation. Clin Orthop Relat Res. 1984 Nov;(190):227-35.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/2269835', 'label': 'Treatment of trans-scaphoid perilunate dislocations by internal fixation with the Herbert screw'}, {'url': 'http://www.wheelessonline.com/ortho/perilunate_dislocations', 'label': 'Perilunate Dislocations'}, {'url': 'http://www.find-health-articles.com/rec_pub_16609406-acute-dorsal-trans-scaphoid-perilunate-dislocations-open-reduction.htm', 'label': 'Acute Dorsal Trans-scaphoid Perilunate Dislocations: Open Reduction and Internal Fixation'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine a surgical technique is effective in the treatment of acute dorsal trans-scaphoid perilunate dislocations.', 'detailedDescription': "Open reduction and internal fixation is an effective method of treating acute trans-scaphoid perilunate dislocations. We study a new surgical technique that allows for early wrist excises postoperatively. We compare this technique to Inoue et al. 's techniques affect the objective and subjective outcomes. We also compared the long-term outcomes of these two procedures performed in similar patient groups.Although both groups had satisfactory results with regard to their pain relief, sufficient grip strength and union of scaphoid fracture, the technique using in group I was more easily and quickly to perform. It allows early postoperative excises and results better functional wrist range of motion."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical treatment of acute trans-scaphoid perilunate dislocations\n* Must have open reduction and internal fixation\n\nExclusion Criteria:\n\n* Patients whose age under 18 years\n* Associated with severe crush, avulsion, or opened injury'}, 'identificationModule': {'nctId': 'NCT00738127', 'acronym': 'ADTPD', 'briefTitle': 'Safety Study of Surgical Technique to Treat Acute Dorsal Trans-Scaphoid Perilunate Dislocations', 'organization': {'class': 'OTHER', 'fullName': 'The Second Hospital of Qinhuangdao'}, 'officialTitle': 'Surgical Techniques for Acute Dorsal Trans-Scaphoid Perilunate Dislocations', 'orgStudyIdInfo': {'id': 'SHQ-0808-A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Group I (treatment with our technique) Eighteen patients (18 wrists) were available for long-term follow-up at an average of 47.8 months after surgery. There were 11 men and seven women. Their mean age at the time of surgery was 35.4 years (range, 22 to 56 years). The dominant hand was involved in 12 patients and the nondominant hand, in six.', 'interventionNames': ['Procedure: Open reduction and internal fixation']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': "Group II (treatment with Inoue et al.'s technique) Fifteen patients (15 wrists) were evaluated at an average of 51 months. Nine patients were men and 6 were women. The mean age of the group at the time of surgery was 37.5 years (range, 24 to 58 years). The dominant hand was involved in 10 and nondominant hand, in seven.", 'interventionNames': ['Procedure: Open reduction and internal fixation']}], 'interventions': [{'name': 'Open reduction and internal fixation', 'type': 'PROCEDURE', 'otherNames': ['Techniques for Perilunate Dislocations'], 'description': "Inoue et al.'s technique is most commonly used which required placing three K-wires to immobilize both midcarpal joint and radiocarpal joint. This technique is effective, however, it has some problems. In the study, we improve the surgical technique.", 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '066600', 'city': 'Qinhuangdao', 'state': 'Hebei', 'country': 'China', 'facility': 'The Second Hospital of Qinhuangdao', 'geoPoint': {'lat': 39.94104, 'lon': 119.58936}}], 'overallOfficials': [{'name': 'Xu Zhang, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'The Second Hospital of Qinhuangdao'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Second Hospital of Qinhuangdao', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Xu Zhang / MD', 'oldOrganization': 'The Second Hospital of Qinhuangdao'}}}}