Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-02-22 @ 7:51 AM
Study NCT ID:
NCT05044767
Status:
RECRUITING
Last Update Posted:
2023-02-01
First Post:
2021-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Performance and Safety of ATF Implants and Lapé Médical Devices Implanted During Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019644', 'term': 'Arthroplasty, Replacement, Hip'}, {'id': 'D062785', 'term': 'Hemiarthroplasty'}], 'ancestors': [{'id': 'D019643', 'term': 'Arthroplasty, Replacement'}, {'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4500}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2032-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-31', 'studyFirstSubmitDate': '2021-09-06', 'studyFirstSubmitQcDate': '2021-09-06', 'lastUpdatePostDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Long-term survival rate', 'timeFrame': '10 years', 'description': 'Long-term survival rate of the prostheses (10 years) with failure defined as revision surgery when considering all causes using Kaplan-Meier method.'}], 'secondaryOutcomes': [{'measure': 'hip joint function', 'timeFrame': 'before and after surgery (6 month, 2 years, 5 years, 7 years, 10 years)', 'description': "The evolution of hip joint function, and in this case the degree of physical disability before and after an intervention with Merle d'Aubigné score (PMA score) or Harris Hip Score (HHS score) or Parker score"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arthroplasty, Hip, Replacement']}, 'descriptionModule': {'briefSummary': 'Observational and prospective multicenter study to evaluate the long-term (10 years) performance and safety (10 years) of ATF Implants and Lapé Médical devices implanted during total hip arthroplasty or hemiarthroplasty.', 'detailedDescription': 'Observational and prospective multicenter study to evaluate the long-term (10 years) performance and safety (10 years) of ATF Implants and Lapé Médical devices implanted during total hip arthroplasty or hemiarthroplasty.\n\nThe post-market clinical follow-up study to be conducted by ATF Implants following this plan aims to collect data from the follow-up of patients before and after hip replacement surgery with implants manufactured by ATF Implants and Lapé médical. In current practice, the surgeon-investigator evaluates the patient pre- and post-operatively according to predefined criteria used in orthopedic surgery and more particularly in hp replacement surgery. Complications and adverse effects observed are also recorded.\n\nThe main objective is to gather clinical evidence to evaluate the survival rate of ATP Implants and Lapé médical hip prostheses over the long-term, namely 10 years.\n\nThe secondary objectives are to evaluate the performance and safety of the prostheses over the same period (i.e. 10 years), as well as to obtain feedback on the performance /intended use and safety of the surgical instruments required for implant placement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male or female indicated for hip replacement surgery with hip prosthesis manufactured by ATF Implants and/or Lapé médical.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female indicated for hip replacement surgery with hip prosthesis manufactured by ATF Implants and/or Lapé médical;\n\nThere are different indications for hip replacement surgery. The main ones are listed below:\n\n* Dysplasia\n* Primary Coxarthrosis\n* Secondary Coxarthrosis\n* Perthes disease\n* Epiphysiolysis\n* Ankylosing spondylitis\n* Trochanteric bursitis\n* Arthritis\n* Degenerative arthritis\n* Post-traumatic arthritis\n* Rheumatoid arthritis\n* Femoral neck fracture\n* Osteonecrosis\n* Revision\n\nDepending on the specificities of the devices (size, absence/presence of a coating, material), indications may vary. This information can be found in the instruction for use. It is the surgeon's responsibility to select the most appropriate prosthesis for a given patient according to the patient's medical records and the instruction for use in force at the time of the procedure accompanying the medical device.\n\nExclusion Criteria:\n\n* There are various contraindications for hip arthroplasty. The main ones are listed below:\n\n * An acute or chronic, local or systemic infection\n * Severe muscular, neurological or vascular deficiency compromising the affected extremity\n * A bone defect or insufficient bone quality that may compromise the stability of the implant\n * Any concomitant disease (dysplastic coxarthrosis with extreme coxa valga, short neck and severe varus) that may affect the function of the implant\n * Sensitivity to the material (allergy) Depending on the specificities of the devices (size, absence/presence of a coating, material), contraindications may vary. This information can be found in the instruction for use of the devices."}, 'identificationModule': {'nctId': 'NCT05044767', 'briefTitle': 'Study to Evaluate the Performance and Safety of ATF Implants and Lapé Médical Devices Implanted During Hip Arthroplasty', 'organization': {'class': 'INDUSTRY', 'fullName': 'ATF Implants'}, 'officialTitle': 'Observational and Prospective Multicenter Study to Evaluate the Long-term (10 Years) Performance and Safety (10 Years) of ATF Implants and Lapé Médical Devices Implanted During Total Hip Arthroplasty or Hemiarthroplasty.', 'orgStudyIdInfo': {'id': 'PEPS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'total hip arthroplasty', 'type': 'DEVICE', 'otherNames': ['hemiarthroplasty'], 'description': 'hip replacement surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33076', 'city': 'Bordeaux', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Vincent Souillac', 'role': 'CONTACT', 'email': 'vincent.souillac@chu-bordeaux.fr', 'phone': '556795544', 'phoneExt': '+33'}, {'name': 'Vincent Souillac, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Bordeaux - Hôpital Pellegrin', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '31700', 'city': 'Cornebarrieu', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jonathan Hourtal', 'role': 'CONTACT', 'email': 'jonathanhourtal@gmail.com', 'phone': '562133131', 'phoneExt': '+33'}, {'name': 'Jonathan Hourtal, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinique des Cèdres', 'geoPoint': {'lat': 43.64967, 'lon': 1.32588}}, {'zip': '38130', 'city': 'Échirolles', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Claude Panisset', 'role': 'CONTACT', 'email': 'dr.panisset@gmail.com', 'phone': '476481485', 'phoneExt': '+33'}, {'name': 'Jean-Claude Panisset, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Ostéo-Articulaire des Cèdres', 'geoPoint': {'lat': 45.14603, 'lon': 5.71441}}, {'zip': '07500', 'city': 'Guilherand-Granges', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Richard Philippe', 'role': 'CONTACT', 'email': 'rphilippe@orange.fr', 'phone': '475823180', 'phoneExt': '+33'}, {'name': 'Richard Philippe, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital privé Drôme Ardèche', 'geoPoint': {'lat': 44.93278, 'lon': 4.87372}}, {'zip': '59700', 'city': 'Marcq-en-Barœul', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe Laffargue', 'role': 'CONTACT', 'email': 'plaffargue@yahoo.fr', 'phone': '891650494', 'phoneExt': '+33'}, {'name': 'Philippe Laffargue, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinique du Croisé Laroche', 'geoPoint': {'lat': 50.66667, 'lon': 3.08333}}, {'zip': '06100', 'city': 'Nice', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Hervé Ovadia', 'role': 'CONTACT', 'email': 'docteur@ovadia.fr', 'phone': '493817150', 'phoneExt': '+33'}, {'name': 'Hervé Ovadia, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Polyclinique Saint George', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75020', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Simon Marmor', 'role': 'CONTACT', 'email': 'smarmor@hopital-dcss.org', 'phone': '144641600', 'phoneExt': '+33'}, {'name': 'Simon Marmor, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Groupe Hospitalier Diaconesses Croix Saint-Simon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '86000', 'city': 'Poitiers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre Bouget', 'role': 'CONTACT', 'email': 'pbouget@hotmail.fr', 'phone': '549444492', 'phoneExt': '+33'}, {'name': 'Pierre Bouget, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '17138', 'city': 'Puilboreau', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Cédric Bouquet', 'role': 'CONTACT', 'email': 'docteurbouquet@gmail.com', 'phone': '536288500', 'phoneExt': '+33'}, {'name': 'Cédric Bouquet, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Clinique de l'Atlantique", 'geoPoint': {'lat': 46.18563, 'lon': -1.11804}}, {'zip': '42055', 'city': 'Saint-Etienne', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Frédéric Farizon', 'role': 'CONTACT', 'email': 'frederic.farizon@chu-st-etienne.fr', 'phone': '477120372', 'phoneExt': '+33'}, {'name': 'Frédéric Farizon, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU St Etienne, Hôpital Nord', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'zip': '34200', 'city': 'Sète', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'François Lozach', 'role': 'CONTACT', 'email': 'francois.lozach@gmail.com', 'phone': '467536286', 'phoneExt': '+33'}, {'name': 'François Lozach, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Polyclinique Sainte Thérèse', 'geoPoint': {'lat': 43.4028, 'lon': 3.69278}}, {'zip': '67000', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'David Dagrenat', 'role': 'CONTACT', 'email': 'dagrenat.ortho@gmail.com', 'phone': '388360088', 'phoneExt': '+33'}, {'name': 'David Dagrenat, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Clinique de l'Orangerie", 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '93290', 'city': 'Tremblay-en-France', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Faouzi Madi', 'role': 'CONTACT', 'email': 'faouzimadi2@gmail.com', 'phone': '826309393', 'phoneExt': '+33'}, {'name': 'Faouzi Madi, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital privé du Vert Galant', 'geoPoint': {'lat': 48.94956, 'lon': 2.5684}}], 'centralContacts': [{'name': 'Philippe Laffargue, Pr', 'role': 'CONTACT', 'email': 'plaffargue@yahoo.fr', 'phone': '891650494', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Philippe Laffargue, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinique du Croisé Laroche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ATF Implants', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}