Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2026-01-01 @ 9:51 AM
Study NCT ID:
NCT04503759
Status:
COMPLETED
Last Update Posted:
2024-05-13
First Post:
2020-07-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Artoss Foot and Ankle Surgery Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081084', 'term': 'Accidental Injuries'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-10', 'studyFirstSubmitDate': '2020-07-30', 'studyFirstSubmitQcDate': '2020-08-05', 'lastUpdatePostDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Clinical Success', 'timeFrame': '6-months', 'description': 'Change from baseline in Visual Analog Scale (VAS) pain score (0=no pain, 10=worst possible pain'}, {'measure': 'Function', 'timeFrame': '6-months', 'description': 'Change from baseline in Foot and Ankle Ability Measure (FAAM)'}], 'primaryOutcomes': [{'measure': 'Radiographic Success', 'timeFrame': '6-months', 'description': "Fusion/Graft Consolidation: Evidence of bony (osseous) bridging between the graft material and the patient's bone in the segment requiring fusion or reconstruction."}], 'secondaryOutcomes': [{'measure': 'Safety Evaluation', 'timeFrame': '6-months', 'description': 'Occurrence of Complications or Adverse Events'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arthritis Foot', 'Trauma Injury', 'Deformity; Bone']}, 'descriptionModule': {'briefSummary': 'This prospective registry was designed as an observational study to ascertain how commercially available NanoBone products are being used by surgeons performing foot and ankle surgery which involves bone grafting, as well as determining relevant patient outcomes.', 'detailedDescription': 'This multicenter prospective patient registry was developed with the aim of documenting how surgeons are utilizing NanoBone products in foot and ankle surgery along with relevant patient outcomes. These outcomes include radiographic measures such as fusion or graft consolidation success, instrumentation integrity, and clinical outcomes (symptom and function improvement) based on investigator and patient-based outcome assessments.\n\nThe primary objective of this study is to document and analyze the use of NanoBone products in foot and ankle surgery (as a stand-alone bone graft, no other local bone, autograft, bone graft substitute, or biologic product used) and determine both radiographic success and clinical outcomes. All product related adverse events will be documented, tabulated, and summarized.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "All patients in the study will be drawn from the individual surgeons' practice. Patients will be among those already scheduled for foot and ankle surgery after having failed conservative treatment, or will have had foot and ankle surgery using NanoBone products but have not completed their standard of care follow-up as determined by the surgeon's practice. In addition, the surgeon has determined that the use of a NanoBone product is or was clinically necessary for the patient. The choice of a NanoBone product, as well as the surgery, is or was independent of this research project. Only patients who have had NanoBone implanted and consent to participate and meet the inclusion-exclusion criteria will be included in the registry.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient aged 18 years or older.\n* Patient is or was diagnosed with a pathology of the foot or ankle, having failed conservative treatment, and surgeon has determined that surgery with bone graft is medically necessary.\n* The surgeon has determined that NanoBone is or was clinically indicated.\n* NanoBone will be or was used as a stand-alone bone graft (no autograft, other bone graft substitute, or biologic planned or used).\n* Patient capable of understanding the content of the Informed Consent Form\n* Patient willing and able to participate in the registry protocol including the surgeon's standard follow-up visits and clinical evaluations.\n* Patient who has agreed to participate in the registry by providing consent according to the applicable local law and the declaration of Helsinki.\n\nExclusion Criteria:\n\n* Severe vascular or neurological disease\n* Uncontrolled diabetes\n* Severe degenerative disease (other than degenerative disc disease)\n* Severely impaired renal function\n* Hypercalcemia, abnormal calcium metabolism\n* Existing acute or chronic infections, especially at the site of the operation\n* Inflammatory bone disease such as osteomyelitis\n* Malignant tumors\n* Patients who are or plan to become pregnant.\n* Uncooperative patients who cannot or will not follow post-operative instruction, including individuals who abuse drugs and/or alcohol."}, 'identificationModule': {'nctId': 'NCT04503759', 'acronym': 'ARK', 'briefTitle': 'Artoss Foot and Ankle Surgery Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Artoss Inc.'}, 'officialTitle': 'Multicenter Prospective Registry to Evaluate Use and Outcomes of NanoBone in Foot and Ankle Surgery', 'orgStudyIdInfo': {'id': 'HAF002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Foot and Ankle Surgery using NanoBone', 'description': "All patients in the study will be drawn from the individual surgeons' practice. Patients will be among those already scheduled for foot and ankle surgery after having failed conservative treatment, or will have had foot and ankle surgery using NanoBone products but have not completed their standard of care follow-up as determined by the surgeon's practice. In addition, the surgeon has determined that the use of a NanoBone product is or was clinically necessary for the patient. The choice of a NanoBone product, as well as the surgery, is or was independent of this research project. Only patients who have had NanoBone implanted and consent to participate and meet the inclusion-exclusion criteria will be included in the registry.", 'interventionNames': ['Other: NanoBone Bone Graft Substitute']}], 'interventions': [{'name': 'NanoBone Bone Graft Substitute', 'type': 'OTHER', 'otherNames': ['nanoHA-SiO2'], 'description': 'Synthetic, biodegradable bone grafting material that is composed of non-sintered nanocrystalline hydroxyapatite (HA) which is embedded in a silica gel matrix (amorphous SiO2). The ratio of HA/SiO2 has been chosen to optimize the rate of biodegradation for treatment of osseous defects in human bone. NanoBone does not contain any components of animal or human origin, eliminating the possibility of transmission of infection or disease.', 'armGroupLabels': ['Foot and Ankle Surgery using NanoBone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85251', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix Foot and Ankle Institute', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Orthopedic Foot & Ankle Center', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '60435', 'city': 'Joliet', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois Orthopedic Institute', 'geoPoint': {'lat': 41.52519, 'lon': -88.0834}}, {'zip': '61270', 'city': 'Morrison', 'state': 'Illinois', 'country': 'United States', 'facility': 'Morrison Hospital', 'geoPoint': {'lat': 41.80975, 'lon': -89.96512}}, {'zip': '46254', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Podiatry Associates of Indiana', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46901', 'city': 'Kokomo', 'state': 'Indiana', 'country': 'United States', 'facility': 'Hoosier Foot and Ankle', 'geoPoint': {'lat': 40.48643, 'lon': -86.1336}}, {'zip': '50266', 'city': 'West Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'The Iowa Clinic', 'geoPoint': {'lat': 41.57721, 'lon': -93.71133}}, {'zip': '55805', 'city': 'Duluth', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Orthopedic Associates of Duluth', 'geoPoint': {'lat': 46.78327, 'lon': -92.10658}}], 'overallOfficials': [{'name': 'Jim Cassidy, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Artoss Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Artoss Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}