Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2025-12-28 @ 3:35 PM
Study NCT ID:
NCT05391204
Status:
UNKNOWN
Last Update Posted:
2022-05-25
First Post:
2022-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reproducibility of Strength Testing and Functional Testing of the Hip for the Return to Sport of Patients Activated by a Femoroacetabular Impingement: Comparison Between a Group of Patients and a Group of Healthy Controls
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057925', 'term': 'Femoracetabular Impingement'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There is therefore a lack of specific clinical tests allowing the functional evaluation of the hip. This is why it is necessary to study the possibility of deploying tests evaluating the functional capacities of the lower limb to characterize the functions of the hip.\n\nThe study will compare patients group versus healthy volunteers and reproducibility.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2023-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-20', 'studyFirstSubmitDate': '2022-05-20', 'studyFirstSubmitQcDate': '2022-05-20', 'lastUpdatePostDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reproducibility rate', 'timeFrame': '8 months', 'description': 'intra- and inter-session reproducibility'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['femoroacetabular Impingement', 'Reproducibility of strength testing and functional testing'], 'conditions': ['Femoroacetabular Impingement']}, 'descriptionModule': {'briefSummary': 'Reproducibility of strength testing and functional testing of the hip for the return to sport of patients activated by a femoroacetabular impingement: comparison between a group of patients and a group of healthy controls Femoroacetabular impingement is a disorder movement-related hip clinic, with bone abnormality at the joint coxo-femoral associated with a triad of symptoms, clinical signs and findings imagery. It represents premature contact symptomatic between the femur and the acetabulum. Currently, there is no consensus for determine when to return to sport securely after processing arthroscopy of a emoroacetabular impingement. Various clinical tests are used to assess the mobility or pain but no test studies specifically the level of recovery functional.', 'detailedDescription': 'Reproducibility of strength testing and functional testing of the hip for the return to sport of patients activated by a femoroacetabular impingement: comparison between a group of patients and a group of healthy controls Femoroacetabular impingement is a disorder movement-related hip clinic, with bone abnormality at the joint coxo-femoral associated with a triad of symptoms, clinical signs and findings imagery. It represents premature contact symptomatic between the femur and the acetabulum. Currently, there is no consensus for determine when to return to sport securely after processing arthroscopy of a emoroacetabular impingement. Various clinical tests are used to assess the mobility or pain but no test studies specifically the level of recovery functional.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients\n\n* Male or female aged 16 to 50\n* Occurrence of the injury requiring surgery during a sports activity\n* Hip arthroscopy\n* Surgery performed by surgeons from the Santy Orthopedic Center (Lyon)\n* Angle Alpha \\> 55°\n* Patient having signed an informed consent\n* Affiliated subject or beneficiary of a social Security\n\nControl group\n\n* Male or female aged 16 to 50\n* Practicing a regular sporting activity In both groups\n* Patient having signed an informed consent\n* Affiliated subject or beneficiary of a social Security\n\nExclusion Criteria:\n\nPatient group\n\n* Contraindication of the surgeon\n* Present another pathology of the hip on the side of the operated limb or on the contralateral side\n\nControl group\n\n* Declare a history of lower limb pain/injury in the last 12 months\n* Declare a history of orthopedic surgery on the lower limbs\n\nIn any case will be excluded Protected subject: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.'}, 'identificationModule': {'nctId': 'NCT05391204', 'acronym': 'H-Repro', 'briefTitle': 'Reproducibility of Strength Testing and Functional Testing of the Hip for the Return to Sport of Patients Activated by a Femoroacetabular Impingement: Comparison Between a Group of Patients and a Group of Healthy Controls', 'organization': {'class': 'OTHER', 'fullName': 'Ramsay Générale de Santé'}, 'officialTitle': 'Reproducibility of Strength Testing and Functional Testing of the Hip for the Return to Sport of Patients Activated by a Femoroacetabular Impingement: Comparison Between a Group of Patients and a Group of Healthy Controls', 'orgStudyIdInfo': {'id': '2020-A01382-37'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy Volunteers', 'description': 'To answer the question of reproducibility of the measurement (1st objective), half of the group control will carry out two handover of the battery of functional tests to a week apart.', 'interventionNames': ['Other: Functional Tests']}, {'type': 'EXPERIMENTAL', 'label': 'Patients Volunteers', 'description': 'To answer the question of reproducibility of the measurement (1st objective), half the group patient will perform two examinations at two months apart.', 'interventionNames': ['Other: Functional Tests']}], 'interventions': [{'name': 'Functional Tests', 'type': 'OTHER', 'description': 'Various physical exercices of inferior members', 'armGroupLabels': ['Healthy Volunteers', 'Patients Volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69000', 'city': 'Lyon', 'state': 'AURA', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mathieu THAUNAT, DR', 'role': 'CONTACT', 'email': 'mathieuthaunat@yahoo.fr', 'phone': '0437530703'}, {'name': 'Isabelle ROGOWSKI,', 'role': 'CONTACT', 'email': 'abelle.rogowski@univ-lyon1.fr'}], 'facility': 'Centre Santy', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'centralContacts': [{'name': 'JF ECTEN', 'role': 'CONTACT', 'email': 'jf.oudet@ecten.eu', 'phone': '0683346567'}, {'name': 'MH BARBA', 'role': 'CONTACT', 'email': 'mh.barba@ecten.eu', 'phone': '0664888704'}], 'overallOfficials': [{'name': 'Mathieu THAUNAT, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre santy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ramsay Générale de Santé', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ramsay santé', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}