Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-01-02 @ 8:39 AM
Study NCT ID:
NCT01048450
Status:
COMPLETED
Last Update Posted:
2011-08-19
First Post:
2010-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical Treatment for Hallux Rigidus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020857', 'term': 'Hallux Limitus'}, {'id': 'D020859', 'term': 'Hallux Rigidus'}, {'id': 'D001168', 'term': 'Arthritis'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001174', 'term': 'Arthrodesis'}, {'id': 'D007595', 'term': 'Joint Prosthesis'}], 'ancestors': [{'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-17', 'studyFirstSubmitDate': '2010-01-11', 'studyFirstSubmitQcDate': '2010-01-12', 'lastUpdatePostDateStruct': {'date': '2011-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective: pain, function, alignment', 'timeFrame': 'At least 1 year after surgical intervention'}], 'secondaryOutcomes': [{'measure': 'Frequency and types of undesired effects', 'timeFrame': 'At least 1 year after surgical intervention'}, {'measure': 'Demographic data and trends', 'timeFrame': 'At least 1 year after surgical intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['arthritis', 'degeneration'], 'conditions': ['Hallux Limitus', 'Hallux Rigidus']}, 'referencesModule': {'references': [{'pmid': '16174497', 'type': 'BACKGROUND', 'citation': 'Gibson JN, Thomson CE. Arthrodesis or total replacement arthroplasty for hallux rigidus: a randomized controlled trial. Foot Ankle Int. 2005 Sep;26(9):680-90. doi: 10.1177/107110070502600904.'}, {'pmid': '18829931', 'type': 'BACKGROUND', 'citation': 'Raikin SM, Ahmad J. Comparison of arthrodesis and metallic hemiarthroplasty of the hallux metatarsophalangeal joint. Surgical technique. J Bone Joint Surg Am. 2008 Oct;90 Suppl 2 Pt 2:171-80. doi: 10.2106/JBJS.H.00368.'}], 'seeAlsoLinks': [{'url': 'http://www.acfas.org', 'label': "Sponsor's Web site"}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the long-term outcomes for the surgical treatment of end stage degeneration in the big toe joint.', 'detailedDescription': "Hallux rigidus is a degenerative process that occurs in the first metatarsophalangeal joint (MTPJ). There are a variety of surgical treatment options available for its treatment including joint sparing and joint destructive procedures. Patients with end stage arthritis are often given several surgical options for the treatment of the first MTPJ. The procedures are correlated to the patient's age, type of shoe gear, activity level, Body Mass Index, degree of arthritis, desire for joint mobility and bone density. This proposal outlines a retrospective study on the long-term efficacy of joint resection, joint fusion, and hemi-metallic first MTPJ implants. A multi-center study of 300 subjects who received surgical repair for end stage arthritis of the first MTPJ will be evaluated. Subjective assessment for pain, function and alignment as well as objective radiographic evaluation will be performed. Further, the frequency and types of adverse events associated with the three surgical techniques will be assessed. The results of this study will provide valuable information to foot and ankle surgeons in making appropriate decisions regarding the treatment options for end stage hallux rigidus."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* End stage hallux limitus/rigidus\n* Status post 1 year since having the surgery\n* Must have had a joint resection, fusion, or hemi-metallic implant\n\nExclusion Criteria:\n\n* History of seropositive or seronegative arthritis\n* Have had a primary surgery before then had one of the above surgeries performed'}, 'identificationModule': {'nctId': 'NCT01048450', 'briefTitle': 'Surgical Treatment for Hallux Rigidus', 'organization': {'class': 'OTHER', 'fullName': 'American College of Foot and Ankle Surgeons'}, 'officialTitle': 'A Multi-Center Retrospective Review of Resectional Arthroplasty, Arthrodesis and, Hemi-Metallic Joint Implants in the Surgical Treatment of End Stage Hallux Rigidus', 'orgStudyIdInfo': {'id': '0709-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Those who were diagnosed with hallux limitus/rigidus (end stage degeneration at the 1st metatarsal phalangeal joint)', 'interventionNames': ['Radiation: Joint Resection- Keller Procedure', 'Procedure: Joint Fusion', 'Procedure: Hemi-metallic Joint Implant']}], 'interventions': [{'name': 'Joint Resection- Keller Procedure', 'type': 'RADIATION', 'otherNames': ['Keller Arthoplasty'], 'description': 'These subjects had received a surgical intervention of removing the proximal portion of the proximal phalanx of the hallux', 'armGroupLabels': ['Treatment']}, {'name': 'Joint Fusion', 'type': 'PROCEDURE', 'otherNames': ['Arthrodesis'], 'description': 'Those who had a surgical intervention of fusion of the 1st metatarsal phalangeal joint.', 'armGroupLabels': ['Treatment']}, {'name': 'Hemi-metallic Joint Implant', 'type': 'PROCEDURE', 'otherNames': ['Joint Implant'], 'description': 'Those who had a surgical procedure of a hemi-metallic joint implant', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80634', 'city': 'Greeley', 'state': 'Colorado', 'country': 'United States', 'facility': 'Foot & Ankle Center of Northern Colorado', 'geoPoint': {'lat': 40.42331, 'lon': -104.70913}}, {'zip': '50325', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Capitol Orthopaedics & SPorts Medicine', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '02066', 'city': 'Scituate', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Scituate Podiatry Group', 'geoPoint': {'lat': 42.19593, 'lon': -70.72587}}, {'zip': '48034', 'city': 'Southfield', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Foot & Ankle Center', 'geoPoint': {'lat': 42.47337, 'lon': -83.22187}}, {'zip': '44512', 'city': 'Youngstown', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ankle and Foot Care Centers', 'geoPoint': {'lat': 41.09978, 'lon': -80.64952}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Marc Kravettte', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Paul J Kim, DPM', 'role': 'STUDY_DIRECTOR', 'affiliation': 'American College of Foot & Ankle Surgeons'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'American College of Foot and Ankle Surgeons', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Paul J Kim, DPM, FACFAS, Associate Professor', 'oldOrganization': 'American College of Foot and Ankle Surgeons'}}}}