Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2026-02-21 @ 9:25 PM
Study NCT ID:
NCT05084703
Status:
UNKNOWN
Last Update Posted:
2021-10-20
First Post:
2021-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reproducibility of Functional Shoulder Tests for the Return to Sport of Patients Operated on Previous Shoulder Instability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070599', 'term': 'Shoulder Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2022-04-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-06', 'studyFirstSubmitDate': '2021-10-06', 'studyFirstSubmitQcDate': '2021-10-06', 'lastUpdatePostDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symmetry indices between the two limbs obtained thanks to the scores of the functional tests', 'timeFrame': '1 hour', 'description': 'using the Y balance test'}, {'measure': 'Muscle endurance index obtained from functional test scores', 'timeFrame': '1 hour', 'description': 'Using : Closed Kinetic Chain Upper Extremitie Stability test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Latarjet', 'Shoulder Injuries']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess whether the indicators outcome of these tests discriminate between different populations. In particular to compare populations with shoulders without any history of injury with a population that had undergone a reduction in glenohumeral instability by the Latarjet technique.', 'detailedDescription': 'The different objectives of this study are :\n\n* To assess the intra- and intersessional reproducibility of functional shoulder tests\n* To evaluate the influence of an anterior front stop using the Latarjet method on the functional profile of the shoulder compared to a healthy population.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatient group :\n\n* Male patient\n* Between 18 and 30 years-old\n* Occurrence of the injury requiring surgery during a sports activity\n* Reduction of shoulder instability by the Latarjet technique\n* Surgery performed by surgeon from Santy orthopedic center (Lyon)\n* Patient's inclusion by decision of the surgeon during the 4 months postoperatively visit\n\nHealthy volunteer group :\n\n* Male patient\n* Between 18 and 30 years-old\n* Patient regularly practicing sport activity.\n\nBoth groups :\n\n* Patient having signed an informed consent\n* Affiliated subject or beneficiary of a social security scheme\n\nExclusion Criteria:\n\nPatient group :\n\n* Contra indication from surgeon\n* Having another pathology in the upper limbs\n* Present a constitutional hyperlaxity\n* Have stiffness or recurrence of dislocation of the shoulder post-surgery\n\nHealthy volunteer group :\n\n* Report a history of upper extremity pain / injury within the past 12 months\n* Report a history of orthopedic surgery on the upper limbs\n\nAll participants :\n\n* Protected subject : adult under guardianship, guardianship or other legal protection, deprived of liberty by judicial or administrative decision\n* pregnant woman, breastfeeding, parturient"}, 'identificationModule': {'nctId': 'NCT05084703', 'briefTitle': 'Reproducibility of Functional Shoulder Tests for the Return to Sport of Patients Operated on Previous Shoulder Instability', 'organization': {'class': 'OTHER', 'fullName': 'Ramsay Générale de Santé'}, 'officialTitle': 'Reproducibility of Functional Shoulder Tests for the Return to Sport of Patients Operated on Previous Shoulder Instability', 'orgStudyIdInfo': {'id': '2018-A03013-52'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients operated for previous shoulder instability', 'description': 'Different functionnal test to be done', 'interventionNames': ['Other: Functional tests']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy volunteer', 'description': 'Different functionnal test to be done', 'interventionNames': ['Other: Functional tests']}], 'interventions': [{'name': 'Functional tests', 'type': 'OTHER', 'description': '* Symmetry indices between the two limbs obtained thanks to the scores of the functional tests : Y balance test\n* Muscle endurance index obtained from functional test scores : Closed Kinetic Chain Upper Extremitie Stability test', 'armGroupLabels': ['Healthy volunteer', 'Patients operated for previous shoulder instability']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69008', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lionel Neyton, Dr', 'role': 'CONTACT', 'email': 'neyton.lionel@orange.fr', 'phone': '04 37 53 00 57'}], 'facility': 'Hopital privé Jean Mermoz', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'centralContacts': [{'name': 'Jean-François Oudet', 'role': 'CONTACT', 'email': 'jf.oudet@ecten.eu', 'phone': '0683346567'}, {'name': 'Marie-Hélène Barba', 'role': 'CONTACT', 'email': 'mh.barba@ecten.eu'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ramsay Générale de Santé', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Clinical Trial Experts Network', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}