Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT05552235
Status:
UNKNOWN
Last Update Posted:
2023-01-17
First Post:
2022-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of the Safety and Performance of an Elbow Brace in the Prevention of Injuries During Sports Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092464', 'term': 'Elbow Injuries'}], 'ancestors': [{'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-13', 'studyFirstSubmitDate': '2022-09-13', 'studyFirstSubmitQcDate': '2022-09-20', 'lastUpdatePostDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functionnal score', 'timeFrame': 'Change from Baseline functionnal score at 6 weeks', 'description': 'Comparison of the Patient Rated Elbow Evaluation (20-item questionnaire with a global score from 0=best outcome to 100=worst outcome) between the baseline and last follow-up visit in each group (orthosis vs control)'}], 'secondaryOutcomes': [{'measure': 'Confidence level (confidence questionnaire related to physical activity)', 'timeFrame': 'Change from Baseline confidence level at 6 weeks', 'description': 'Gap in the confidence level related to physical activity (6-item questionnaire with a global score from 0=worst outcome to 100=best outcome), between the baseline and last follow-up visit in each group (orthosis vs control)'}, {'measure': 'Elbow pain', 'timeFrame': 'Change from Baseline elbow pain at 6 weeks', 'description': 'Comparison of elbow pain, assessed through a Numerical Rating Scale (NRS) ranging from 0=best outcome to 10=worst outcome, between the groups (orthosis vs control)'}, {'measure': 'Elbow instability', 'timeFrame': 'Change from Baseline elbow instability at 6 weeks', 'description': 'Comparison of elbow instability, assessed through a Numerical Rating Scale (NRS) ranging from 0=best outcome to 10=worst outcome, between the groups (orthosis vs control)'}, {'measure': 'Safety (adverse events)', 'timeFrame': '6 weeks of follow-up', 'description': 'Comparison of adverse events rates between the groups (orthosis vs control)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Epicondylitis', 'Tendonitis Elbow', 'Elbow Injury']}, 'descriptionModule': {'briefSummary': 'Decathlon has developed the Elbow soft300 which is a medical device that must be positioned around the elbow to keep a physical activity on a regular basis in case of chronic epicondylitis, pain associated with tendonitis or chronic instability.\n\nThe objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon Elbow soft 300 product to demonstrate safety and performance of this device in a real-world setting.\n\nOutcome data collected from this study will provide the basis for Post-Market Surveillance (PMS) reporting, Clinical Study Report (CSR), Clinical Evaluation Report (CER) on Decathlon ElbowSoft300 device and support peer-reviewed publications on products performance and safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is aged ≥ 18 years old\n* Subject has a chronic epicondylitis (\\>3 months) OR elbow pain associated with tendonitis OR chronic elbow instability (\\>3 months)\n* The current condition of his/her elbow allows the subject to continue usual physical activity\n* Subject has been informed and is willing to sign an informed consent form\n* Subject is willing to comply with protocol requirements and return to the study center for all clinical evaluations and required follow-up (6 weeks)\n* Subject is affiliated to the French social security regime\n\nExclusion Criteria:\n\n* Subject has conditions that may interfere with his/her ability to understand protocol requirements, participate in scheduled visits, or provide his/her informed consent\n* Subject has worn a support (elbow brace or articulated orthosis) in the last month during his/her sport practice\n* Subject has any medical condition that could impact the study at investigator's discretion\n* Subject has a known hypersensitivity or allergy to the components of the device (polyamide, elastodiene, polyester, elastane)\n* Adult subject to legal protection measure"}, 'identificationModule': {'nctId': 'NCT05552235', 'briefTitle': 'Assessment of the Safety and Performance of an Elbow Brace in the Prevention of Injuries During Sports Practice', 'organization': {'class': 'INDUSTRY', 'fullName': 'Decathlon SE'}, 'officialTitle': 'Assessment of the Safety and Performance of an Elbow Brace in the Prevention of Injuries During Sports Practice', 'orgStudyIdInfo': {'id': 'elbowSOFT300'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Orthosis group', 'description': 'Use of Elbow Soft 300 device during sport practice', 'interventionNames': ['Device: Elbow SOFT 300']}, {'type': 'OTHER', 'label': 'Control group', 'description': 'No medical device used during sport practice', 'interventionNames': ['Other: Control group']}], 'interventions': [{'name': 'Elbow SOFT 300', 'type': 'DEVICE', 'description': '15 patients will be included in this group and will used the medical device ElbowSOFT 300 during sport practice (at least 2 sport sessions per week), for 6 weeks.', 'armGroupLabels': ['Orthosis group']}, {'name': 'Control group', 'type': 'OTHER', 'description': '15 patients will be included in this control group and will performed their sport sessions as usual (without the medical device), for at least 2 sport sessions per week during 6 weeks.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62200', 'city': 'Boulogne-sur-Mer', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Yoann MORVAN', 'role': 'CONTACT', 'email': 'y.morvan@ch-boulogne.fr'}, {'name': 'Yoann MORVAN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier de Boulogne-sur-Mer', 'geoPoint': {'lat': 50.72485, 'lon': 1.61373}}, {'zip': '59000', 'city': 'Lille', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Valérie WIECZOREK', 'role': 'CONTACT', 'email': 'valerie.wieczorek@chru-lille.fr'}, {'name': 'Valérie WIECZOREK', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Universitaire de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'centralContacts': [{'name': 'Jean HEE', 'role': 'CONTACT', 'email': 'jean.hee@btwin.com', 'phone': '07 64 35 00 45', 'phoneExt': '+33'}, {'name': 'Sophie TALLON', 'role': 'CONTACT', 'email': 'stallon@soladis.fr'}], 'overallOfficials': [{'name': 'Valérie WIECZOREK', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Lille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Decathlon SE', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}