Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-02-22 @ 9:05 AM
Study NCT ID:
NCT04118894
Status:
TERMINATED
Last Update Posted:
2025-01-14
First Post:
2019-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Wright Foot & Ankle Post-Market Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D000081084', 'term': 'Accidental Injuries'}, {'id': 'D000844', 'term': 'Ankylosis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jennifer.seidman@stryker.com', 'phone': '9016338616', 'title': 'Jennifer Seidman, Manager, Clinical Research', 'organization': 'Stryker'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Surgery to 1 year', 'description': 'Procedural and device related events will be described and collected on the AE form. It is the responsibility of the operating surgeon/s to be aware and note the adverse effects from the package insert/instructions for use by the manufacturer/sponsor.', 'eventGroups': [{'id': 'EG000', 'title': 'Foot and Ankle Devices', 'description': 'The study subjects included are those treated with one or more approved or cleared Wright Medical products included in this study.', 'otherNumAtRisk': 119, 'deathsNumAtRisk': 119, 'otherNumAffected': 19, 'seriousNumAtRisk': 119, 'deathsNumAffected': 0, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Algodystrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Blister Dorsal Aspect of Operated Foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Inflammatory Scar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound Healing Complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'acute aortic dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Below Knee Amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-Union', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'EuroQol (EQ-5D-5L).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Foot and Ankle Devices', 'description': 'The study subjects included are those treated with one or more approved or cleared Wright Medical products included in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '74.1', 'spread': '22.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': "Comparing the changes in patient-reported pain and social interaction for quality of life from pre-op through post-operatively, assessed by the EuroQol (EQ-5D-5L).\n\nThe descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. This decision results in a 1-digit number that expresses the level selected for that dimension. Health utility values generated from the EQ-5D generally range from 0 (death) to 1 (perfect health). But health utility values less than 0 are possible, and represent health states considered worse than death.\n\nThe EQ VAS records the patient's self-rated health on a VAS (0-100), where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.", 'unitOfMeasure': 'units on a scale- EQ5D VAS', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Foot and Ankle Ability Measure (FAAM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Foot and Ankle Devices', 'description': 'The study subjects included are those treated with one or more approved or cleared Wright Medical products included in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '68.6', 'spread': '25.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Comparing the changes in patient-reported function scores from pre-op through post-operatively, assessed by the FAAM\n\nThe FAAM is a patient-completed instrument that consists of an "Activities of Daily Living" subscale (21 scored items) and a "Sports" subscale (7 scored items) in which the response options are presented as 5-point Likert scales (range 4 to 0). Scores for each subscale range from 0% (least function) to 100% (most function).', 'unitOfMeasure': 'score on a scale- FAAM SANE', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Foot and Ankle Devices', 'description': 'The study subjects included are those treated with one or more approved or cleared Wright Medical products included in this study.\n\nFoot and Ankle Devices: Wright devices used in foot and ankle procedures'}], 'classes': [{'categories': [{'title': 'Subjects that Experienced a Serious Adverse Event', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': "Subjects that Didn't Experience a Serious Adverse Event", 'measurements': [{'value': '110', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'Identifying and reporting the safety of the implant in terms of complications and adverse events. (This is reported in the Adverse Event Section)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety is reported in the adverse event section.'}, {'type': 'SECONDARY', 'title': 'Surgeon Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Foot and Ankle Devices', 'description': 'The study subjects included are those treated with one or more approved or cleared Wright Medical products included in this study.\n\nFoot and Ankle Devices: Wright devices used in foot and ankle procedures'}], 'classes': [{'categories': [{'title': 'Wright product performed as intended- Yes', 'measurements': [{'value': '109', 'groupId': 'OG000'}]}, {'title': 'Wright product performed as intended- No', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'Conducting a surgeon survey including radiographic assessment of fusion and consolidation time', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Foot and Ankle Devices', 'description': 'The study subjects included are those treated with one or more approved or cleared Wright Medical products included in this study.\n\nFoot and Ankle Devices: Wright devices used in foot and ankle procedures'}], 'classes': [{'title': 'Experienced any complications associated with your procedure requiring you to seek medical care?', 'categories': [{'title': 'Yes', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}, {'title': 'Any surgery to remove any device parts associated with your foot/ankle procedure?', 'categories': [{'title': 'Yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '48', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'Conducting patient surveys to assess current implant status (to include complications)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Foot and Ankle Devices', 'description': 'The study subjects included are those treated with one or more approved or cleared Wright Medical products included in this study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '119'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Overall, 119 subjects were enrolled and treated with a study device at 5 sites in the private clinic and hospital setting in the France, Germany, United States and United Kingdom. A subject may have received more than one of the devices under investigation. The first subject was enrolled on January 22, 2020 (aligned with protocol) and the last subject was enrolled on November 1, 2021.', 'preAssignmentDetails': 'No specific method (such as randomization, blinding or stratification) for assigning subjects was used in this protocol. Consecutive subjects at each site meeting all the eligibility criteria were enrolled in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Foot and Ankle Devices', 'description': 'The study subjects included are those treated with one or more approved or cleared Wright Medical products included in this study.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '59.49', 'spread': '13.34', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '79', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Smoking Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Never', 'measurements': [{'value': '77', 'groupId': 'BG000'}]}, {'title': 'Previous', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}, {'title': 'Current, <= 1 Pack/day', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Current, > 1 pack/day', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '28.18', 'spread': '5.58', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-04-18', 'size': 1316232, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-08-12T20:56', 'hasProtocol': True}, {'date': '2021-12-07', 'size': 1173380, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-08-12T20:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Due to COVID the enrollment into the study was delayed. Sponsor chose to collect clinical data via alternative methods.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-10', 'studyFirstSubmitDate': '2019-08-21', 'resultsFirstSubmitDate': '2024-11-05', 'studyFirstSubmitQcDate': '2019-10-07', 'lastUpdatePostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-10', 'studyFirstPostDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EuroQol (EQ-5D-5L).', 'timeFrame': '1 year', 'description': "Comparing the changes in patient-reported pain and social interaction for quality of life from pre-op through post-operatively, assessed by the EuroQol (EQ-5D-5L).\n\nThe descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. This decision results in a 1-digit number that expresses the level selected for that dimension. Health utility values generated from the EQ-5D generally range from 0 (death) to 1 (perfect health). But health utility values less than 0 are possible, and represent health states considered worse than death.\n\nThe EQ VAS records the patient's self-rated health on a VAS (0-100), where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'."}], 'secondaryOutcomes': [{'measure': 'Foot and Ankle Ability Measure (FAAM)', 'timeFrame': '1 year', 'description': 'Comparing the changes in patient-reported function scores from pre-op through post-operatively, assessed by the FAAM\n\nThe FAAM is a patient-completed instrument that consists of an "Activities of Daily Living" subscale (21 scored items) and a "Sports" subscale (7 scored items) in which the response options are presented as 5-point Likert scales (range 4 to 0). Scores for each subscale range from 0% (least function) to 100% (most function).'}, {'measure': 'Safety Assessment', 'timeFrame': '1 year', 'description': 'Identifying and reporting the safety of the implant in terms of complications and adverse events. (This is reported in the Adverse Event Section)'}, {'measure': 'Surgeon Survey', 'timeFrame': '1 year', 'description': 'Conducting a surgeon survey including radiographic assessment of fusion and consolidation time'}, {'measure': 'Patient Survey', 'timeFrame': '1 year', 'description': 'Conducting patient surveys to assess current implant status (to include complications)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Arthritis', 'Rheumatoid Arthritis', 'Fracture', 'Trauma Injury', 'Fusion of Joint']}, 'descriptionModule': {'briefSummary': 'WRIGHT FOOT \\& ANKLE POST-MARKET OBSERVATIONAL STUDY, Multi-Year, Multi-Site, Multi-Device, Post-Market Observational Study, 10 sites, a minimum of 40 patients per device', 'detailedDescription': 'The selected design is a global, multi-center, non-randomized, prospective observational study. The study subjects included are those treated with one or more approved or cleared Wright Medical products included in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The Instructions for Use (IFU) for each individual product can be found at http://www.wright.com/prescribing-use-3.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing and able to consent to participate (written, informed consent);\n* Willing and able to attend/complete the requested follow-up visits;\n* Considered for treatment with one or more approved or cleared Wright Medical products included in this study\n\nExclusion Criteria:\n\n* Subjects determined, by the investigator, to be an inappropriate candidate for the procedure indicated;\n* Unable to consent to participate (written, informed consent);\n* Unable to attend/complete the requested follow-up visits'}, 'identificationModule': {'nctId': 'NCT04118894', 'briefTitle': 'Wright Foot & Ankle Post-Market Observational Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stryker Trauma and Extremities'}, 'officialTitle': 'Wright Foot & Ankle Post-Market Observational Study', 'orgStudyIdInfo': {'id': 'INT19-MDR-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Foot and Ankle Devices', 'description': 'The study subjects included are those treated with one or more approved or cleared Wright Medical products included in this study.', 'interventionNames': ['Device: Foot and Ankle Devices']}], 'interventions': [{'name': 'Foot and Ankle Devices', 'type': 'DEVICE', 'description': 'Wright devices used in foot and ankle procedures', 'armGroupLabels': ['Foot and Ankle Devices']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08691', 'city': 'Hamilton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Mercer-Bucks Orthopaedics', 'geoPoint': {'lat': 40.20706, 'lon': -74.08125}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'OrthoCarolina', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'CHRU Tours, Hôpital Trousseau', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'city': 'Augsburg', 'country': 'Germany', 'facility': 'Hessingpark Clinic', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'city': 'Oswestry', 'state': 'Shropshire', 'country': 'United Kingdom', 'facility': 'Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust', 'geoPoint': {'lat': 52.86195, 'lon': -3.05497}}], 'overallOfficials': [{'name': 'Rebecca Gibson', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Stryker Trauma and Extremities'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stryker Trauma and Extremities', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}