Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-31 @ 1:49 PM
Study NCT ID:
NCT04776356
Status:
TERMINATED
Last Update Posted:
2023-08-28
First Post:
2021-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Effectiveness of the QuickFix Small Staple
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'whyStopped': "it was difficult to obtain subjects' consent", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-24', 'studyFirstSubmitDate': '2021-02-23', 'studyFirstSubmitQcDate': '2021-02-26', 'lastUpdatePostDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Visual Analogue Scale (VAS)', 'timeFrame': 'preoperatively, 2 weeks, 6 week, 3 months, 6 months and 12 months postoperative', 'description': 'Measuring pain in the affected foot. Range 0-10 (0=best, 10=worst).'}, {'measure': 'Change of Foot Function Index (FFI)', 'timeFrame': 'preoperatively, 3 months, 6 months and 12 months postoperative', 'description': 'Measuring foot functionality. Range 0-100 (0=best, 100=worst)'}, {'measure': 'Change of Foot and Ankle Ability Measure (FAAM Sport)', 'timeFrame': 'preoperatively, 3 months, 6 months and 12 months postoperative', 'description': 'Measuring foot functionality. Range 0-100 (0=worst, 100=best)'}, {'measure': 'Change of Veterans RAND 12 Iteam Health Survey (VR-12)', 'timeFrame': 'preoperatively, 6 months and 12 months postoperative', 'description': 'Measuring quality of life. Range 0-100 (0=worst, 100=best)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Staple'], 'conditions': ['Hallux Valgus Interphalangeus']}, 'descriptionModule': {'briefSummary': 'The prospective, post-market, single-center clinical study will include 45 subjects who are candidates for surgery using the Arthrex QuickFix Small Staple for Akin osteotomy to correct hallux valgus interphalangeus. The purpose of the study is to evaluate the continued safety and effectiveness of the device. Device-related adverse events as well as patient reported outcomes (VAS, FFI, FAAM, VR-12) will be collected up to 1 year postoperative.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '45 subjects, male and female, at least 18 years of age from the general population who will be treated with the Arthrex QuickFix Small Staple to correct hallux valgus interphalangeus.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject requires surgery using the Arthrex QuickFix Small Staple for Akin osteotomy.\n2. Subject is 18 years of age or older.\n3. Subject is not considered a vulnerable subject (i.e. child, pregnant, nursing, prisoner, or ward of the state).\n4. Subject signed informed consent and is willing and able to comply with all study requirements.\n\nExclusion Criteria:\n\n1. Insufficient quantity or quality of bone.\n2. Blood supply limitations and previous infections which may retard healing.\n3. Foreign-body sensitivity.\n4. Any active infection or blood supply limitations.\n5. Conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period.\n6. Subjects that are skeletally immature."}, 'identificationModule': {'nctId': 'NCT04776356', 'briefTitle': 'Safety and Effectiveness of the QuickFix Small Staple', 'organization': {'class': 'INDUSTRY', 'fullName': 'Arthrex GmbH'}, 'officialTitle': 'Prospective Study to Evaluate the Continued Safety and Effectiveness of the QuickFix Small Staple to Correct Hallux Valgus Interphalangeus', 'orgStudyIdInfo': {'id': 'AIRR-0012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'QuickFix Small Staple', 'description': 'The QuickFix Small Staple will be used for an Akin osteotomy to correct hallux valgus interphalangeus.', 'interventionNames': ['Device: QuickFix Small Staple (Arthrex)']}], 'interventions': [{'name': 'QuickFix Small Staple (Arthrex)', 'type': 'DEVICE', 'description': 'The Arthrex QuickFix Small Staple enables the surgeon to perform a wedge osteotomy of the first phalanx (Akin). The device is made of stainless steel and designed with barbed leg tips. The staple sizes are 8 and 10 mm wide with a 1 mm diameter.', 'armGroupLabels': ['QuickFix Small Staple']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01662', 'city': 'Meissen', 'country': 'Germany', 'facility': 'Überörtliche Gemeinschaftspraxis für Chirurgie, Unfallchirurgie, Anästhesie und Endoskopie', 'geoPoint': {'lat': 51.16158, 'lon': 13.4737}}], 'overallOfficials': [{'name': 'Tilo Schreiter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Überörtliche Gemeinschaftspraxis für Chirurgie, Unfallchirurgie, Anästhesie und Endoskopie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arthrex GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}