Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 12:34 PM
Study NCT ID:
NCT07335133
Status:
RECRUITING
Last Update Posted:
2026-01-12
First Post:
2026-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Complications of Ankle Arthroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016512', 'term': 'Ankle Injuries'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-05', 'studyFirstSubmitDate': '2026-01-05', 'studyFirstSubmitQcDate': '2026-01-05', 'lastUpdatePostDateStruct': {'date': '2026-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complications occurring within one year following ankle arthroscopy', 'timeFrame': 'One year', 'description': 'Description of all complications occurring within one year following ankle arthroscopy. This description will be based on clinical and functional examinations performed by surgeons and physical therapists.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ankle Injuries and Disorders', 'Surgery Complications']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to describe complications that occurred in the year following surgery, based on follow-up surgical consultations and physical therapy sessions.\n\nThe target population is any adult patient who has undergone ankle surgery performed under arthroscopy.\n\nPrimary outcome is description of all complications occurring within one year following ankle arthroscopy. This description will be based on clinical and functional examinations performed by surgeons and physical therapists.\n\nParticipants will be regularly monitored by the surgeon and physical therapist (15 days postoperative, 3 months, 6 months, and 1 year).\n\nThey will complete self-assessment questionnaires and undergo functional physical therapy tests, including ALR RSI, FAAM AVQ, FAAM Sport, CAIT, and Ankle Go.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient who has been informed and has signed the consent form\n* Patient scheduled for arthroscopic ankle surgery.\n* Patient affiliated with or covered by a health insurance plan\n\nExclusion Criteria:\n\n* Recent traumatic injury (less than 1 month old), physical therapy assessment impossible\n* Inability to follow up for up to one year\n* Patient under legal protection\n* Pregnant woman, patient under guardianship or conservatorship\n* Patient who has already undergone ankle surgery'}, 'identificationModule': {'nctId': 'NCT07335133', 'acronym': 'ARTHRO2025', 'briefTitle': 'Postoperative Complications of Ankle Arthroscopy', 'organization': {'class': 'OTHER', 'fullName': 'Clinique Saint Jean, France'}, 'officialTitle': 'Short- and Medium-term Postoperative Complications of Ankle Arthroscopy', 'orgStudyIdInfo': {'id': '2025-A02186-43'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Cohort of patients who underwent ankle arthroscopy', 'interventionNames': ['Other: Physical therapy and surgery tests and scores']}], 'interventions': [{'name': 'Physical therapy and surgery tests and scores', 'type': 'OTHER', 'description': 'Additional physical therapy and surgery tests and scores are performed on patients.', 'armGroupLabels': ['Cohort of patients who underwent ankle arthroscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34430', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Cecile Spirito', 'role': 'CONTACT', 'email': 'cecile.spirito@capsante.fr', 'phone': '00304 67 41 34 53'}], 'facility': 'Clinique St jean sud de france', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinique Saint Jean, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Wayan HEBRARD', 'investigatorAffiliation': 'Clinique Saint Jean, France'}}}}