Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2026-02-17 @ 4:50 PM
Study NCT ID:
NCT03914703
Status:
COMPLETED
Last Update Posted:
2025-07-01
First Post:
2019-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MDR EZ Pass and Precision Flexible Reamer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}, {'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}], 'ancestors': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D012421', 'term': 'Rupture'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jarrod.hunnicutt@zimmerbiomet.com', 'phone': '574-453-7834', 'title': 'Jarrod Hunnicutt, Clinical Affairs Manager', 'organization': 'Zimmer Biomet'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Among the limitations of the study was that it was comprised of a single center of non-randomized enrollment. Additional limitations include no patient reported outcome measures or post-operative follow-up visits.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events occurring on the day of surgery were reported and assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'EZ Pass Suture Passer', 'description': 'Patients who have surgery using the EZ Pass Suture Passer Instrument either in rotator cuff or soft tissue repair\n\nEZ Pass Suture Passer: open or arthroscopic instrument utilized in conjunction with a nitinol wire or nylon monofilament to aid in passing suture through soft tissue', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 5, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Precision Flexible Reamer', 'description': 'Patients who have surgery using the Precision Flexible Reamer Instrument in ACL repair\n\nPrecision Flexible Reamer: handheld device intended to be used in ACL and PCL reconstruction surgeries to manipulate tissue, or in conjunction with other devices in these surgeries.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 2, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Instrument Malfunction', 'notes': 'Kite broke when grabbed with Suture Grasper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Instrument Malfunction', 'notes': 'Kite would not advance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Performance of Instruments (EZ Pass Suture Passer and Precision Flexible Reamer)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EZ Pass Suture Passer', 'description': 'Patients who have surgery using the EZ Pass Suture Passer Instrument either in rotator cuff or soft tissue repair\n\nEZ Pass Suture Passer: open or arthroscopic instrument utilized in conjunction with a nitinol wire or nylon monofilament to aid in passing suture through soft tissue'}, {'id': 'OG001', 'title': 'Precision Flexible Reamer', 'description': 'Patients who have surgery using the Precision Flexible Reamer Instrument in ACL repair\n\nPrecision Flexible Reamer: A handheld device intended to be used in ACL and PCL reconstruction surgeries to manipulate tissue, or in conjunction with other devices in these surgeries.'}], 'classes': [{'categories': [{'title': 'Performed as Expected', 'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}, {'title': 'Did Not Perform as Expected', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Intraoperative', 'description': 'Questionnaire was completed to assess if the Instrument Performed as Expected. Surgeon provided yes/no answers on their opinion if the instrument performed as expected during the procedure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Absence of Instrument Related Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EZ Pass Suture Passer', 'description': 'Patients who have surgery using the EZ Pass Suture Passer Instrument either in rotator cuff or soft tissue repair\n\nEZ Pass Suture Passer: open or arthroscopic instrument utilized in conjunction with a nitinol wire or nylon monofilament to aid in passing suture through soft tissue'}, {'id': 'OG001', 'title': 'Precision Flexible Reamer', 'description': 'Patients who have surgery using the Precision Flexible Reamer Instrument in ACL repair\n\nPrecision Flexible Reamer: A handheld device intended to be used in ACL and PCL reconstruction surgeries to manipulate tissue, or in conjunction with other devices in these surgeries.'}], 'classes': [{'categories': [{'title': 'Subject with No Instrument-Related Serious Adverse Event', 'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}, {'title': 'Subject with Instrument-Related Serious Adverse Event', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Intraoperative', 'description': 'This outcome will measure the frequency of instrument related serious adverse events', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Questionnaire will be used to assess whether subjects had any instrument-related serious adverse events. Responses are yes/no.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'EZ Pass Suture Passer', 'description': 'Patients who have surgery using the EZ Pass Suture Passer Instrument either in rotator cuff or soft tissue repair\n\nEZ Pass Suture Passer: open or arthroscopic instrument utilized in conjunction with a nitinol wire or nylon monofilament to aid in passing suture through soft tissue'}, {'id': 'FG001', 'title': 'Precision Flexible Reamer', 'description': 'Patients who have surgery using the Precision Flexible Reamer Instrument in ACL repair\n\nPrecision Flexible Reamer: handheld/hand-manipulated device intended to be used in ACL or PCL reconstruction surgeries, intended to manipulate tissue or in conjunction with other devices'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'EZ Pass Suture Passer', 'description': 'Patients who have surgery using the EZ Pass Suture Passer Instrument either in rotator cuff or soft tissue repair\n\nEZ Pass Suture Passer: open or arthroscopic instrument utilized in conjunction with a nitinol wire or nylon monofilament to aid in passing suture through soft tissue'}, {'id': 'BG001', 'title': 'Precision Flexible Reamer', 'description': 'Patients who have surgery using the Precision Flexible Reamer Instrument in ACL repair\n\nPrecision Flexible Reamer: handheld/hand-manipulated device intended to be used in ACL or PCL reconstruction surgeries, intended to manipulate tissue or in conjunction with other devices'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '54.1', 'groupId': 'BG000', 'lowerLimit': '20.0', 'upperLimit': '78.0'}, {'value': '30.6', 'groupId': 'BG001', 'lowerLimit': '18.0', 'upperLimit': '54.0'}, {'value': '47.02', 'groupId': 'BG002', 'lowerLimit': '18.0', 'upperLimit': '78.0'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'Patients who have received either the EZ Pass Suture Passer or the Precision Flexible Reamer.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-04-27', 'size': 346423, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-02-25T13:44', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-27', 'studyFirstSubmitDate': '2019-04-11', 'resultsFirstSubmitDate': '2025-02-25', 'studyFirstSubmitQcDate': '2019-04-11', 'lastUpdatePostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-27', 'studyFirstPostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance of Instruments (EZ Pass Suture Passer and Precision Flexible Reamer)', 'timeFrame': 'Intraoperative', 'description': 'Questionnaire was completed to assess if the Instrument Performed as Expected. Surgeon provided yes/no answers on their opinion if the instrument performed as expected during the procedure.'}, {'measure': 'Absence of Instrument Related Serious Adverse Events', 'timeFrame': 'Intraoperative', 'description': 'This outcome will measure the frequency of instrument related serious adverse events'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anterior Cruciate Ligament Injury', 'Rotator Cuff Tear']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to confirm the safety and performance on the EZPass Suture Passer Instrumentation and the Precision Flexible Reamer Instrumentation.', 'detailedDescription': 'The primary objective of the study is to assess performance, clinical benefits and safety of the EZPass Suture Passer and the Precision Flexible Reamer Instrumentation.\n\nPerformance and clinical benefits will be assessed through an operative survey conducted immediately following intraoperative surgery to determine if the device performed as expected.\n\nSafety will be assessed by recording and analyzing the incidence and frequency of complications, adverse events, and intra-operative revisions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population should be a consecutive series of subjects where the EZPass Suture Passer or Precision Flexible Reamer instrumentation will be used.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* EZ Pass Suture Passer:\n\n \\- Intended as an open or arthroscopic instrument utilized in conjunction with a nitinol wire or nylon monofilament to aid in passing suture through soft tissue.\n* Precision Flexible Reamer:\n\n * This device is a hand held, or hand-manipulated device, intended to be used in ACL and PCL reconstruction surgeries and is intended for medical purposes to manipulate tissue, or for use with other devices in these surgeries.\n\nExclusion Criteria\n\n* EZ Pass Suture Passer:\n\n \\- Any use other than the approved uses indicated in the Instructions for Use (IFU).\n* Precision Flexible Reamer:\n\n * Any use other than the approved uses indicated in the Instructions for Use (IFU).'}, 'identificationModule': {'nctId': 'NCT03914703', 'briefTitle': 'MDR EZ Pass and Precision Flexible Reamer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zimmer Biomet'}, 'officialTitle': 'Post-market Clinical Follow-up Study to Collect Safety, Performance and Clinical Data of the EZPass Suture Passer (Instrumentation) and Precision Flexible Reamers (Instrumentation)- A Retrospective Consecutive Series Study', 'orgStudyIdInfo': {'id': 'MDRG2017-89MS-32SM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'EZ Pass Suture Passer', 'description': 'Patients who have surgery using the EZ Pass Suture Passer Instrument either in rotator cuff or soft tissue repair', 'interventionNames': ['Procedure: EZ Pass Suture Passer']}, {'label': 'Precision Flexible Reamer', 'description': 'Patients who have surgery using the Precision Flexible Reamer Instrument in ACL repair', 'interventionNames': ['Procedure: EZ Pass Suture Passer']}], 'interventions': [{'name': 'EZ Pass Suture Passer', 'type': 'PROCEDURE', 'description': 'Instruments used to help with rotator cuff or ACL repair', 'armGroupLabels': ['EZ Pass Suture Passer', 'Precision Flexible Reamer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28277', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'OrthoCarolina', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}], 'overallOfficials': [{'name': 'Erin Osborn', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zimmer Biomet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zimmer Biomet', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}