Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT01825356
Status:
COMPLETED
Last Update Posted:
2023-02-09
First Post:
2013-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Amniotic Membrane as an Adjunct Treatment for Hallux Rigidus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020859', 'term': 'Hallux Rigidus'}], 'ancestors': [{'id': 'D005531', 'term': 'Foot Deformities, Acquired'}, {'id': 'D005530', 'term': 'Foot Deformities'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-08', 'studyFirstSubmitDate': '2013-04-02', 'studyFirstSubmitQcDate': '2013-04-04', 'lastUpdatePostDateStruct': {'date': '2023-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'American Orthopedic Foot and Ankle Society (AOFAS) score', 'timeFrame': '6 Months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hallux Rigidus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether patients undergoing a dorsal cheilectomy procedure with implementation of amniotic membrane tissue results in improved clinical and functional outcomes compared to a standard dorsal cheilectomy procedure.\n\nSpecific Aim 1:\n\nTo compare American Orthopedic Foot and Ankle Society (AOFAS) scores between patients undergoing dorsal cheilectomy to patients undergoing dorsal cheilectomy with implantation of amniotic membrane tissue.\n\nHypothesis 1: Clinical and functional outcomes, as measured by the AOFAS , in the patients undergoing dorsal cheilectomy with implantation of amniotic membrane tissue will be superior to those without.\n\nSpecific Aim 2:\n\nTo compare range of motion between patients undergoing dorsal cheilectomy to patients undergoing dorsal cheilectomy with implantation of amniotic membrane tissue.\n\nHypothesis 2: Patient to undergo dorsal cheilectomy and implantation of amniotic membrane tissue will demonstrate less postoperative stiffness as measured from the pre-and postoperative radiographs.\n\nSpecific Aim 3:\n\nTo compare Foot Function Index (FFI) scores between patients undergoing dorsal cheilectomy to patients undergoing dorsal cheilectomy with implantation of amniotic membrane tissue.\n\nHypothesis 3: Clinical and functional outcomes, as measured by the FFI, the patients undergoing dorsal cheilectomy with implantation of amniotic membrane tissue will be superior to those without.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients presented with an isolated diagnosis of type II hallux rigidus who are candidates for operative management with dorsal cheilectomy.\n* Patients over the age of 18 able to consent to participate\n* The subject is psychosocially, mentally, and physically able to understand and comply with the requirements of the study\n\nExclusion Criteria:\n\n* \\< 18 years of age\n* Patients that use ambulatory assistive devices\n* Patients with systemic inflammtory arthritis\n* Patient undergoing revision surgery for hallux rigidus to the ipsilateral extremity\n* Patients with significant arthritis requiring alternative surgery other than dorsal cheilectomy'}, 'identificationModule': {'nctId': 'NCT01825356', 'briefTitle': 'Amniotic Membrane as an Adjunct Treatment for Hallux Rigidus', 'organization': {'class': 'OTHER', 'fullName': 'OrthoCarolina Research Institute, Inc.'}, 'orgStudyIdInfo': {'id': '03-13-03A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dorsal Cheilectomy no Amniotic Membrane Tissue Implantation', 'description': 'Dorsal cheilectomy is a surgery for hallux rigidus(degenerative arthritis and stiffness due to bone spurs that affect the joint at the base of the big toe). No amniotic membrane will be used for this group.', 'interventionNames': ['Procedure: Dorsal Cheilectomy without Amniotic Membrane Tissue Implantation']}, {'type': 'EXPERIMENTAL', 'label': 'Dorsal Cheilectomy-Amniotic Membrane Tissue Implantation', 'description': 'Dorsal cheilectomy procedure with the addition of the amniotic membrane. Amniotic membrane represents a biologic therapy that has the ability to actively regulate myrofibroblast formation and activity within the joint space and surgical site', 'interventionNames': ['Procedure: Dorsal Cheilectomy with Amniotic Membrane Tissue Implantation']}], 'interventions': [{'name': 'Dorsal Cheilectomy without Amniotic Membrane Tissue Implantation', 'type': 'PROCEDURE', 'armGroupLabels': ['Dorsal Cheilectomy no Amniotic Membrane Tissue Implantation']}, {'name': 'Dorsal Cheilectomy with Amniotic Membrane Tissue Implantation', 'type': 'PROCEDURE', 'armGroupLabels': ['Dorsal Cheilectomy-Amniotic Membrane Tissue Implantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'OrthoCarolina', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}], 'overallOfficials': [{'name': 'John K Ellington, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OrthoCarolina Research Institute, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OrthoCarolina Research Institute, Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}