Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-30 @ 5:10 AM
Study NCT ID:
NCT05691868
Status:
RECRUITING
Last Update Posted:
2025-02-27
First Post:
2023-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vantage Mobile Bearing Total Ankle System Post Market Clinical Follow-up (Outside US)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D011475', 'term': 'Prosthesis Failure'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2031-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-26', 'studyFirstSubmitDate': '2023-01-11', 'studyFirstSubmitQcDate': '2023-01-11', 'lastUpdatePostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AOFAS', 'timeFrame': 'Through study completion, an average of 1 per year', 'description': 'American Orthopedic Foot and Ankle Society Score (AOFAS) - Questionaire on pain (40 points), function (45 points) , and alignment (15 points) - 100 points score where 100 indicates a healthy midfoot'}, {'measure': 'SMFA', 'timeFrame': 'Through study completion, an average of 1 per year', 'description': 'Short Musculoskeletal Function Assessment (SMFA) Score - 46 items Patient questionnaire divided into two sections: 34 questions on patients function assessment and 12 questions covering how bothered patients are by their symptoms where 1 indicates no problems/no difficulty/ not bothered and 5 indicates unable to do/symptoms all the time/being greatly bothered'}, {'measure': 'SF-36', 'timeFrame': 'Through study completion, an average of 1 per year', 'description': 'Short Form Health Survey (SF-36) Score - 36-item patient-reproted survey of patient health - It consists on 8 scales: Physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Each scale is transformed into a 0-100 scale where the lower score indicates the more disability and the higher score the lest disability'}, {'measure': 'Sports Frequency Score', 'timeFrame': 'Through study completion, an average of 1 per year', 'description': 'Sports Frequency Score - Level of sport activity in leisure time where 0 indicates "no sports activity" and 4 indicates "professional level of sports activity, elite athlete'}, {'measure': 'VAS Pain score and Patient Satisfaction', 'timeFrame': 'Through study completion, an average of 1 per year', 'description': 'Visual Analog Scale (VAS) Score - Range of scores from 0-100 to indicate level of pain - Higher score indicates greater pain intensity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis', 'Arthritis of Ankle', 'Failure, Prosthesis']}, 'descriptionModule': {'briefSummary': 'The objectives of this study are to evaluate the performance and safety of the Vantage Mobile-Bearing Total Angle System. This study will follow subjects for a period of up to 10 years post-surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who meet eligibility criteria - Patients who consent to participate to return for follow-up visits out to 10 years or longer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is indicated for total ankle arthroplasty\n* Patient is at least 21 years of age\n* Patient is likely to be available for follow-up out to 10 years\n* Patient is willing to participate by complying with pre- and postoperative visit requirements\n* Patient is willing and able to read and sign a study informed consent form\n\nExclusion Criteria:\n\n* Patient with excessive bone loss at the ankle joint site\n* Patient with severe osteoporosis\n* Patient with complete talar avascular necrosis\n* Patient with active osteomyelitis\n* Patient with infection at the ankle site or infection at distant sites that could migrate to the ankle\n* Patient with sepsis\n* Patient with vascular deficiency in the involved limb\n* Pateint with neuropathic joints\n* Patient with neurological or musculoskeletal disease or loss of function that may adversely affect movement of the lower limb, gait, or weight bearing\n* Patient with poor soft tissue coverage around the ankle\n* Patient with Charcot arthropathy\n* Previsous ankle arthrodesis with excision of the malleoli\n* Excessive loads as cuased by activity or patient weight - per investigator discretion\n* Skeletally immature patients (patient is less than 21 years if age at time of surgery)\n* Patient with dementia\n* Patient with known metal allergies\n* Patients who are unwilling to provide informed consent\n* Patients who are unlikely to be available for follow-up out to 10 years\n* Patients who are not deemed suitable candidates for the subject device\n* Patient is pregnant'}, 'identificationModule': {'nctId': 'NCT05691868', 'briefTitle': 'Vantage Mobile Bearing Total Ankle System Post Market Clinical Follow-up (Outside US)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Exactech'}, 'officialTitle': 'An Open Label, Multi-Center, Single Arm Prospective Evaluation of Exactech Vantage Total Ankle System (Outside US)', 'orgStudyIdInfo': {'id': 'CR16-004'}}, 'contactsLocationsModule': {'locations': [{'zip': '38320', 'city': 'Santa Cruz de Tenerife', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Alejandro Herrera', 'role': 'CONTACT', 'phone': '+ 0034 922678500'}], 'facility': 'Hospital Universitario de Canarias', 'geoPoint': {'lat': 28.46824, 'lon': -16.25462}}, {'zip': 'CH-4010', 'city': 'Basel', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Victor Valderrabano', 'role': 'CONTACT', 'phone': '+41 61 295 88 80'}], 'facility': 'SWISS ORTHO CENTER Pain Clinic Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'centralContacts': [{'name': 'Rachael Craig', 'role': 'CONTACT', 'email': 'rachael.craig@exac.com', 'phone': '352-377-1140'}, {'name': 'Sandrine Angibaud', 'role': 'CONTACT', 'email': 'sandrine.angibaud@exac.com', 'phone': '352-377-1140'}], 'overallOfficials': [{'name': 'Victor Valderrabano, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SWISS ORTHO CENTER Pain Clinic Basel'}, {'name': 'Mario Herrera- Perez, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario de Canarias'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Exactech', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}