Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2025-12-27 @ 9:15 PM
Study NCT ID:
NCT01413061
Status:
COMPLETED
Last Update Posted:
2018-04-13
First Post:
2011-08-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Subtalar Arthrodesis Using AlloStem® Versus Autologous Bone Graft
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-11', 'studyFirstSubmitDate': '2011-08-08', 'studyFirstSubmitQcDate': '2011-08-09', 'lastUpdatePostDateStruct': {'date': '2018-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fusion Rate (%)(as determined by CT assessment)', 'timeFrame': '6 months post-op', 'description': 'Fusion Rate (%)(as determined by CT assessment)'}], 'secondaryOutcomes': [{'measure': 'Radiographic outcome assessments', 'timeFrame': 'Pre-operatively, 6 weeks, 3, 6, 12 and 24 months', 'description': 'Radiographic outcome assessments'}, {'measure': 'Functional outcome measurements', 'timeFrame': 'Pre-operatively, 6 weeks, 3, 6, 12 and 24 months', 'description': 'FFI-R, SF-12'}, {'measure': 'Functional outcome measurements', 'timeFrame': 'Pre-operatively, 3, 6, 12 and 24 months', 'description': 'AOFAS'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Other Hindfoot Conditions requiring Subtalar Arthrodesis', 'Post-traumatic Arthritis'], 'conditions': ['Degenerative Osteoarthritis', 'Post-traumatic; Arthrosis', 'Rheumatoid Arthritis & Other Inflammatory Polyarthropathies', 'Rheumatoid Arthritis of Subtalar Joint']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical trial is to evaluate the outcome of implanting AlloStem® graft with appropriate rigid internal fixation hardware as an alternative to autograft bone graft with rigid fixation in subtalar arthrodesis procedures. The primary objective of this clinical trial is to compare the overall fusion rate of the investigational to the control treatment. Fusion will be determined by clinical findings, radiographs and computed tomography (CT) of the subtalar joint 24 weeks (6 months) after the trial surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Must be diagnosed with degenerative osteoarthritis, post-traumatic arthritis, inflammatory arthritis (ie: rheumatoid arthritis) or other conditions of the hindfoot requiring subtalar arthrodesis.\n2. Patients must be able to attend follow-up examinations for the duration of the trial.\n3. The patient is at least 18 years of age and skeletally mature, or less than 80 years of age at the time of surgery.\n4. Is willing and able to comply with the clinical trial plan and able to understand and sign the Patient Informed Consent Form.\n\nExclusion Criteria:\n\n1. Younger than 18 years old or older than 80 years old.\n2. Has a condition that prevents ambulation or completion of any of the trial measurements.\n3. Requires fusion of additional hindfoot or ankle joints simultaneously (i.e. a pantalar, tibiotalocalcaneal or triple arthrodesis). Concomitant midfoot or forefoot procedures, such as osteotomies, tendon or metatarsal procedures are not exclusionary.\n4. Has treatment planned for the arthrodesis which does not require the use of screws.\n5. Has any active infection of the hindfoot, a systemic infection or bacteremia.\n6. Has received any treatment within the past 12 months which may interfere with bone metabolism \\[bisphosphonates (Fosamax, Actonel, Boniva, Reclast) and calcitonin (Miacalcin)\\].\n7. Is scheduled to have any surgical procedure on the contralateral foot within 6 weeks before or after the study procedure.'}, 'identificationModule': {'nctId': 'NCT01413061', 'briefTitle': 'Study of Subtalar Arthrodesis Using AlloStem® Versus Autologous Bone Graft', 'organization': {'class': 'INDUSTRY', 'fullName': 'AlloSource'}, 'officialTitle': 'Study of Subtalar Arthrodesis Using AlloStem® Versus Autologous Bone Graft', 'orgStudyIdInfo': {'id': 'AlloSource Subtalar Fusion RCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'AlloStem Live Cellular Allograft', 'description': 'AlloStem is the combination of the Mesenchymal Stem Cells (MSC) derived from adipose with demineralized bone.', 'interventionNames': ['Procedure: Subtalar Arthrodesis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control: Autologous Bone Marrow Aspirate', 'description': "Autologous bone graft is recovered from the patient's own tibia or iliac crest, for transplantation in the subtalar joint.", 'interventionNames': ['Procedure: Subtalar Arthrodesis']}], 'interventions': [{'name': 'Subtalar Arthrodesis', 'type': 'PROCEDURE', 'armGroupLabels': ['AlloStem Live Cellular Allograft', 'Control: Autologous Bone Marrow Aspirate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21202', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Institute for Foot and Ankle Reconstruction at Mercy', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '49525', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Orthopaedic Associates of Michigan', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '55435', 'city': 'Edina', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Orthopedic Sports Medicine Institute (MOSMI)', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Milton S. Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '38138', 'city': 'Germantown', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Campbell Clinic', 'geoPoint': {'lat': 35.08676, 'lon': -89.81009}}], 'overallOfficials': [{'name': 'Christiaan Coetzee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Minnesota Orthopedic Sports Medicine Institute (MOSMI)'}, {'name': 'Mark Myerson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute for Foot and Ankle Reconstruction at Mercy'}, {'name': 'John Anderson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orthopaedic Associates of Michigan'}, {'name': 'Paul Juliano, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Milton S. Hershey Medical Center'}, {'name': 'Andrew Murphy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Campbell Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AlloSource', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}