Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2025-12-25 @ 8:29 PM
Study NCT ID:
NCT00969969
Status:
COMPLETED
Last Update Posted:
2016-11-15
First Post:
2009-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Effectiveness and Safety of an Implant in the Treatment of Osteoarthritis of the Great Toe
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020859', 'term': 'Hallux Rigidus'}, {'id': 'D020857', 'term': 'Hallux Limitus'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D005531', 'term': 'Foot Deformities, Acquired'}, {'id': 'D005530', 'term': 'Foot Deformities'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D018409', 'term': 'Foot Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001174', 'term': 'Arthrodesis'}], 'ancestors': [{'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 236}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-10', 'studyFirstSubmitDate': '2009-09-01', 'studyFirstSubmitQcDate': '2009-09-01', 'lastUpdatePostDateStruct': {'date': '2016-11-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS, FAAM, Safety', 'timeFrame': 'up to 2 years', 'description': 'The individual components of the primary outcome measures will be Visual Analog Scale (VAS) Pain, Foot and Ankle Ability Measure (FAAM) Sports sub-scale score and absence of key safety issues.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['First MTP Joint', 'Hallux Rigidus', 'Hallux Limitus', 'Cartilage Replacement', 'Osteoarthritis', 'First MTP Joint Osteoarthritis', 'Big Toe Pain'], 'conditions': ['Osteoarthritis of First Metatarsalphalangeal Joint']}, 'descriptionModule': {'briefSummary': 'This study will evaluate whether Cartiva is an effective treatment for individuals with osteoarthritis of the great toe.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years of age\n* Osteoarthritis of the first metatarsophalangeal joint and is a candidate for arthrodesis\n* Presence of good bone stock\n* Capable of completing self-administered questionnaires\n\nExclusion Criteria:\n\n* \\< 18 years of age\n* Osteoarthritis of the first metatarsophalangeal joint, though is not a candidate for arthrodesis\n* Active bacterial infection of the foot\n* Additional ipsilateral limb (hip, knee, ankle, or foot) pathology that requires active treatment (surgery or brace)'}, 'identificationModule': {'nctId': 'NCT00969969', 'briefTitle': 'A Study to Evaluate the Effectiveness and Safety of an Implant in the Treatment of Osteoarthritis of the Great Toe', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cartiva, Inc.'}, 'officialTitle': 'A Study to Evaluate the Effectiveness and Safety of an Implant in the Treatment of Osteoarthritis of the Great Toe', 'orgStudyIdInfo': {'id': 'PTC-0031'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arthrodesis', 'description': 'Fusion', 'interventionNames': ['Device: Arthrodesis']}, {'type': 'EXPERIMENTAL', 'label': 'Cartiva', 'description': 'Synthetic Cartilage Implant', 'interventionNames': ['Device: Cartiva']}], 'interventions': [{'name': 'Arthrodesis', 'type': 'DEVICE', 'description': 'arthrodesis using screws and/or a plate', 'armGroupLabels': ['Arthrodesis']}, {'name': 'Cartiva', 'type': 'DEVICE', 'description': 'Cartiva Synthetic Cartilage Implant', 'armGroupLabels': ['Cartiva']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 4N1', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V6Z 1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "St. Paul's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'E3B 5N5', 'city': 'Fredericton', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'Horizon Health Network', 'geoPoint': {'lat': 45.94541, 'lon': -66.66558}}, {'zip': 'B3H 3A7', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Queen Elizabeth Science Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'M5C 1R6', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'GU16 7UJ', 'city': 'Frimley', 'state': 'Camberley', 'country': 'United Kingdom', 'facility': 'Frimley Park Hospital - Surrey Foot and Ankle Clinic', 'geoPoint': {'lat': 51.31667, 'lon': -0.74544}}, {'zip': 'SW17 0QT', 'city': 'Tooting', 'state': 'London', 'country': 'United Kingdom', 'facility': "St. George's Hospital", 'geoPoint': {'lat': 51.42524, 'lon': -0.16394}}, {'zip': 'HA7 4LP', 'city': 'Stanmore', 'state': 'Middlesex', 'country': 'United Kingdom', 'facility': 'Royal National Orthopaedic Hospital - Stanmore Foot & Ankle Clinic', 'geoPoint': {'lat': 51.61667, 'lon': -0.31667}}, {'zip': 'S5 7AU', 'city': 'Sheffield', 'state': 'South Yorkshire', 'country': 'United Kingdom', 'facility': 'Northern General Hospital NHS Trusts - Sheffield Orthopaedics', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'zip': 'GU2 5XX', 'city': 'Guildford', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'Royal Surrey County Hospital', 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}, {'zip': 'TQ2 7AA', 'city': 'South Devon', 'state': 'Torquay', 'country': 'United Kingdom', 'facility': 'Torbay Hospital'}], 'overallOfficials': [{'name': 'Judith Baumhauer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cartiva, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}