Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2026-02-02 @ 12:11 AM
Study NCT ID:
NCT01912027
Status:
UNKNOWN
Last Update Posted:
2013-10-11
First Post:
2013-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open Latarjet Techniques Versus Arthroscopic Latarjet Techniques on Anterior Shoulder Instability: The Comparison of Clinical and Radiographic Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2014-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-10-09', 'studyFirstSubmitDate': '2013-07-18', 'studyFirstSubmitQcDate': '2013-07-29', 'lastUpdatePostDateStruct': {'date': '2013-10-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The functional and clinical outcomes are evaluated with the range of motion(ROM),VAS scores, UCLA scores, Constant scores, ASES scores and SST scores. The radiographic outcome is also assessed with X-ray plain film .', 'timeFrame': 'up to 3 years'}]}, 'conditionsModule': {'conditions': ['Shoulder Instability']}, 'descriptionModule': {'briefSummary': 'The open Latarjet techniques has benn considered as an effective treatment on anterior shoulder instability.Over the past decade there has been a shift from open to all-arthroscopic technique in many surgeries. The arthroscopic technique may result in less postoperative stiffness and faster rehabilitation. So we hypothesized that the arthroscopic Latarjet techniques would have better clinical and radiographic outcomes than the open Latarjet Techniques on anterior shoulder instability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age older than 15 years\n* Traumatic anterior shoulder instability\n* Recurrent instability\n* Glenoid defects larger than 25%\n* Clinical and radiographic data at pre-operation and follow-up\n\nExclusion Criteria:\n\n* Younger than 18 years\n* Non-traumatic shoulder instability\n* Primary episode of instability\n* Glenoid defects less than 25%\n* Previous surgical procedure Incomplete clinical or radiographic data Combination with rotator cuff tear'}, 'identificationModule': {'nctId': 'NCT01912027', 'briefTitle': 'Open Latarjet Techniques Versus Arthroscopic Latarjet Techniques on Anterior Shoulder Instability: The Comparison of Clinical and Radiographic Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Jishuitan Hospital'}, 'orgStudyIdInfo': {'id': 'JST1307A2'}, 'secondaryIdInfos': [{'id': 'JST130701', 'type': 'OTHER', 'domain': 'Beijing Jishuitan Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arthroscopic Latarjet technique', 'description': 'Arthroscopic Latarjet technique', 'interventionNames': ['Procedure: Arthroscopic Latarjet techniques']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Open Latarjet technique', 'description': 'Open Latarjet technique', 'interventionNames': ['Procedure: Open Latarjet technique']}], 'interventions': [{'name': 'Open Latarjet technique', 'type': 'PROCEDURE', 'armGroupLabels': ['Open Latarjet technique']}, {'name': 'Arthroscopic Latarjet techniques', 'type': 'PROCEDURE', 'armGroupLabels': ['Arthroscopic Latarjet technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100035', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'LI', 'role': 'CONTACT', 'email': 'long_bmu@163.com'}], 'facility': 'Beijing Jishuitan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '0086', 'city': 'Beijng', 'state': 'Beijing Municipality', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Beijing Jishuitan Hospital'}], 'centralContacts': [{'name': 'F Li, MD', 'role': 'CONTACT', 'email': 'long_bmu@163.com', 'phone': '0086-010-58516202'}], 'overallOfficials': [{'name': 'Chunyan Jiang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Jishuitan Hospitial'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fenglong Li, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Fenglong Li, MD', 'investigatorAffiliation': 'Beijing Jishuitan Hospital'}}}}