Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT01028469
Status:
UNKNOWN
Last Update Posted:
2009-12-15
First Post:
2009-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Artelon Metatarsophalangeal (MTP) Spacer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D020859', 'term': 'Hallux Rigidus'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D005531', 'term': 'Foot Deformities, Acquired'}, {'id': 'D005530', 'term': 'Foot Deformities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'lastUpdateSubmitDate': '2009-12-14', 'studyFirstSubmitDate': '2009-12-08', 'studyFirstSubmitQcDate': '2009-12-08', 'lastUpdatePostDateStruct': {'date': '2009-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain, function and alignment of the treated toe evaluated by the investigator using the American Orthopeadic Foot & Ankle Society (AOFAS) clinical rating system.', 'timeFrame': 'pre-treatment and 12 months post-op'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoarthritis', 'Hallux Rigidus']}, 'descriptionModule': {'briefSummary': 'The aim of this prospective, case series is to evaluate the surgical treatment of painful and disabling osteoarthrosis in the MTP-I joint by insertion of an Artelon MTP Spacer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient experiences pain and limitations of the great toe dorsiflexion at the MTP-I joint.\n* The patient has a clinically and radiographically verified arthritis in the MTP-I joint indicating the need for surgical treatment.\n* The patient reads, understands and is able to complete the study questionnaires in Swedish.\n* The patient has received written and oral information regarding the study and has signed the informed consent form.\n\nExclusion criteria:\n\n* The patient has a pronounced hallux rigidus without mobility in the MTP-I joint (ROM = 0°).\n* The patient has previously received surgical treatment affecting the anatomy of the MTP-I joint.\n* The patient has a systemic rheumatic disease, ongoing infection, hallux valgus or is seriously ill.'}, 'identificationModule': {'nctId': 'NCT01028469', 'briefTitle': 'Artelon Metatarsophalangeal (MTP) Spacer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Artimplant AB'}, 'officialTitle': 'Artelon MTP Spacer - Surgical Treatment of Mild to Moderate Hallux Rigidus', 'orgStudyIdInfo': {'id': 'KP026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Artelon MTP Spacer', 'description': 'Metatarsophalageal hemi-implant', 'interventionNames': ['Device: Artelon MTP Spacer']}], 'interventions': [{'name': 'Artelon MTP Spacer', 'type': 'DEVICE', 'description': 'Metatarsophalangeal hemi-implant', 'armGroupLabels': ['Artelon MTP Spacer']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mölndal', 'status': 'RECRUITING', 'country': 'Sweden', 'facility': 'Sahlgrenska Universitetssjukhuset, Område Ortopedi, Mölndal', 'geoPoint': {'lat': 57.6554, 'lon': 12.01378}}], 'centralContacts': [{'name': 'Martin Alund, M.D.', 'role': 'CONTACT', 'email': 'martin.alund@vgregion.se'}], 'overallOfficials': [{'name': 'Martin Alund, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sahlgrenska University Hospital, Mölndal, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Artimplant AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Katrin Gisselfalt, Chief Research & Development', 'oldOrganization': 'Artimplant'}}}}