Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2026-01-01 @ 10:21 PM
Study NCT ID:
NCT05190159
Status:
COMPLETED
Last Update Posted:
2022-09-23
First Post:
2021-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monster Screw System Post-Market Clinical Follow-Up Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016512', 'term': 'Ankle Injuries'}, {'id': 'D018409', 'term': 'Foot Injuries'}], 'ancestors': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-22', 'studyFirstSubmitDate': '2021-12-20', 'studyFirstSubmitQcDate': '2021-12-29', 'lastUpdatePostDateStruct': {'date': '2022-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of secondary procedures', 'timeFrame': 'Up to 9 months', 'description': 'Safety will be assessed by recording the incidence of secondary procedures related to the index procedure'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'Up to 9 months', 'description': 'Safety will be assessed by recording the incidence of adverse events'}], 'secondaryOutcomes': [{'measure': 'Rate of Nonunion', 'timeFrame': 'Up to 9 months', 'description': 'Safety as related to the rate of nonunion of the area treated with the index device'}, {'measure': 'Rate of Maintenance of Correction', 'timeFrame': 'Up to 9 months', 'description': 'Safety as related to the rate of the maintenance of correction'}, {'measure': 'Rate of Index Device Failure', 'timeFrame': 'Up to 9 months', 'description': 'Safety as related to the rate of the failure of the index device'}, {'measure': 'Foot and Ankle Mobility Measure', 'timeFrame': 'Up to 54 months', 'description': 'Device performance and benefits as related to Foot and Ankle Mobility Measure Activities of Daily Living (0-84) subscale and current level of daily activity rating (0-100). The higher the score, the higher the level of function, with 100% representing no dysfunction.'}, {'measure': 'Visual Analog Scale', 'timeFrame': 'Up to 54 months', 'description': 'Device performance and benefits as related to pain levels based on the Visual Analog Scale (range: 0 to 100; 0 = no pain; 100 = worst pain imaginable)'}, {'measure': 'Patient satisfaction', 'timeFrame': 'Up to 54 months', 'description': 'Device performance and benefits as related to patient satisfaction (very satisfied, good, fair, not satisfied)'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Ankle Injuries', 'Foot Injury']}, 'descriptionModule': {'briefSummary': 'Post-market clinical follow-up study on the Monster Screw System', 'detailedDescription': 'Ambispective, multi-surgeon, single site, consecutive case series to determine the safety, performance, and benefits of the Monster Screw System.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The investigational population will include subjects who have undergone a foot and/or ankle procedure that fulfill the eligibility criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subject has undergone a foot and/or ankle procedure using the Monster Screw System and completed by one of the investigators.\n* The subject has adequate radiographic and medical records\n\nFor the Prospective Data Collection:\n\n\\- The subject is willing to provide written informed consent\n\nExclusion Criteria:\n\n-None'}, 'identificationModule': {'nctId': 'NCT05190159', 'briefTitle': 'Monster Screw System Post-Market Clinical Follow-Up Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Paragon 28'}, 'officialTitle': 'Monster Screw System Post-Market Clinical Follow-Up Study', 'orgStudyIdInfo': {'id': 'P20-SP-0001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Monster Screw System', 'interventionNames': ['Device: Monster Screw System']}], 'interventions': [{'name': 'Monster Screw System', 'type': 'DEVICE', 'description': 'Subjects who have undergone a foot and/or ankle procedure involving the index device', 'armGroupLabels': ['Monster Screw System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49201', 'city': 'Jackson', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health Systems', 'geoPoint': {'lat': 42.24587, 'lon': -84.40135}}], 'overallOfficials': [{'name': 'Jacy Legue', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Paragon 28'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Paragon 28', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}