Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-29 @ 3:16 AM
Study NCT ID:
NCT05829733
Status:
RECRUITING
Last Update Posted:
2025-12-12
First Post:
2023-03-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
6-month Efficacy and Safety of Synolis VA 80/160 in Hip Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2023-03-20', 'studyFirstSubmitQcDate': '2023-04-13', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety and tolerability of SYNOLIS VA 80/160', 'timeFrame': 'Month 6', 'description': 'Serious adverse event occurrence'}], 'primaryOutcomes': [{'measure': 'Evolution of the Oxford Hip Score (OXFORD 12)', 'timeFrame': '6 months (M6)', 'description': 'Oxford Hip Score (OXFORD 12) composed of 12 questions measuring pain and hip function. Question includes 5 possible answers corresponding to a value from 1 to 5, with 5 representing the highest level of severity, and 1, the total or almost total absence of symptoms.'}], 'secondaryOutcomes': [{'measure': 'Evolution of the Oxford Hip Score (OXFORD 12)', 'timeFrame': 'Month 3, Month 3 to Month 6', 'description': 'Oxford Hip Score (OXFORD 12) composed of 12 questions measuring pain and hip function. Question includes 5 possible answers corresponding to a value from 1 to 5, with 5 representing the highest level of severity, and 1, the total or almost total absence of symptoms.'}, {'measure': 'Self-assessment symptoms evolution', 'timeFrame': 'Month 3, Month 3 to Month 6', 'description': '7-point Likert scale (-3 to +3)'}, {'measure': 'MCID Oxford Hip Score (OXFORD 12)', 'timeFrame': 'Month 3, Month 3 to Month 6', 'description': 'Minimum clinically important difference on the Oxford Hip Score (OXFORD 12)'}, {'measure': 'Hip prosthesis placement after the injection', 'timeFrame': 'Month 6', 'description': 'Number of Participants with Hip prosthesis placement'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Osteoarthritis', 'Hip osteoarthritis', 'Hyaluronic acid'], 'conditions': ['Osteoarthritis, Hip']}, 'descriptionModule': {'briefSummary': 'Multicenter, independent study of Synolis VA 80/160 over a period of 6 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient over 18 years of age,\n* Patient with osteoarthritis of the hip. The diagnosis is based on the following criteria:\n* Treated hip pain: Oxford score ≥ 21/60,\n* Kellgren-Lawrence positive X-ray stage: II - III (inclusion radiograph dated no more than 6 months before the inclusion visit),\n* Symptoms related to osteoarthritis of the hip for at least 2 months,\n* Failure of treatments (i.e., inadequate or ineffective response to analgesics and/or NSAIDs or intolerance to NSAIDs or low-grade opioids (leaving an OXFORD score ≥ 21/60),\n* Informed consent form signed by the patient,\n* The patient has never had a visco supplement injection or corticosteroid injection in the hip to be treated (or more than 6 months old).\n\nExclusion Criteria:\n\n* Pregnancy,\n* Participation in another clinical trial,\n* Skin lesion near the injection site,\n* Recent or old infection of the affected joint,\n* Patient with a programmed arthroplasty,\n* Patient with a pathology that makes decision-making impossible,\n* The patient must not have undergone non-prosthetic hip-conserving surgery such as osteotomy or arthroscopy less than 12 months old.'}, 'identificationModule': {'nctId': 'NCT05829733', 'briefTitle': '6-month Efficacy and Safety of Synolis VA 80/160 in Hip Osteoarthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aptissen SA'}, 'officialTitle': '6-month Evaluation of the Efficacy and Safety of Synolis VA 80/160 in the Treatment of Symptomatic Hip Osteoarthritis', 'orgStudyIdInfo': {'id': 'PMCF A-SYN400 Hip'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SYNOLIS VA 80/160', 'description': 'Single guided intra-articular injection of SYNOLIS VA 80/160', 'interventionNames': ['Device: SYNOLIS VA 80/160']}], 'interventions': [{'name': 'SYNOLIS VA 80/160', 'type': 'DEVICE', 'description': 'SYNOLIS VA 80/160 (hyaluronic acid 80 mg, sorbitol 160 mg)', 'armGroupLabels': ['SYNOLIS VA 80/160']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Belfort', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thierry Conrozier, Dr', 'role': 'CONTACT'}], 'facility': 'Service de Rhumatologie, Hôpital Nord Franche-Comté', 'geoPoint': {'lat': 47.64218, 'lon': 6.85385}}, {'city': 'Dunkirk', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nicolas Jan, Dr', 'role': 'CONTACT'}], 'facility': 'Service de chirurgie orthopédique et traumatologie Centre Hospitalier de Dunkerque CHD', 'geoPoint': {'lat': 51.0344, 'lon': 2.37681}}, {'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Henri Migaud, Pr', 'role': 'CONTACT'}], 'facility': "Service d'Orthopédie II (Membre Inférieur, Chirurgie du Sport et Chirurgie Septique) Hôpital Salengro, CHRU de Lille", 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'centralContacts': [{'name': 'Eduard Vidovic, MD', 'role': 'CONTACT', 'email': 'clinic@aptissen.com', 'phone': '+41225522104'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aptissen SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}