Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-02-22 @ 7:03 AM
Study NCT ID:
NCT01849458
Status:
COMPLETED
Last Update Posted:
2017-06-22
First Post:
2013-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
BioFiber Scaffold Post-Market Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'marcela.bravo@tornier.com', 'phone': '9526837481', 'title': 'Marcela Bravo', 'organization': 'Tornier Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 Months', 'eventGroups': [{'id': 'EG000', 'title': 'BioFiber', 'description': 'Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold', 'otherNumAtRisk': 50, 'otherNumAffected': 1, 'seriousNumAtRisk': 50, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Clot', 'notes': 'Focal 1 cm superficial clot in mid left basilica vein. Reported as not related to device and possibly related to procedure.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}], 'seriousEvents': [{'term': 'Infection', 'notes': 'Left shoulder deep abscess and suspected septic arthritis of glenohumeral joint.\n\nNot related to device, possible relatedness to procedure.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Stroke', 'notes': 'Acute ischemic Stroke, multiple punctate infarcts in the first posterior, frontal and parietal lobes.\n\nNot related to device, not related to procedure.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Deep Vein Thrombosis', 'notes': 'Deep Vein Thrombosis/pulmonary embolism. Not related to device, possible relatedness to procedure.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Device Associated Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BioFiber', 'description': 'Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 Months', 'description': "The primary objective is to report the number of participants with device associated adverse events.\n\nDevice associated adverse events are defined as adverse events that are classified as possibly or definitely related to the study product or procedure, or anticipated adverse events listed in the product's Instruction for Use regardless of relationship to the study device.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Functional Outcome - Adjusted Constant-Murley Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BioFiber', 'description': 'Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold'}], 'classes': [{'categories': [{'measurements': [{'value': '93.4', 'spread': '17.5', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '32.6', 'ciLowerLimit': '25.2', 'ciUpperLimit': '40', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '26', 'groupDescription': 'Difference from baseline (6M-Baseline)', 'statisticalMethod': '2-sided, paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '6 Months', 'description': 'Evaluate clinical functional outcome Adjusted Constant-Murley Score. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient.\\[1\\] The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function. A score of 0 is considered the worst outcome and 100 is considered the best outcome.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '50 Participants'}, {'type': 'SECONDARY', 'title': 'Clinical Functional Outcome - Adjusted Constant-Murley Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BioFiber', 'description': 'Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold'}], 'classes': [{'categories': [{'measurements': [{'value': '97.1', 'spread': '16.1', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35.7', 'ciLowerLimit': '28.7', 'ciUpperLimit': '42.7', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '23.6', 'groupDescription': 'Difference from baseline (12M-Baseline)', 'statisticalMethod': '2-sided, paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '12 Month', 'description': 'Evaluate clinical functional outcome Adjusted Constant-Murley Score. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient.\\[1\\] The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function. A score of 0 is considered the worst outcome and 100 is considered the best outcome.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Functional Outcome - WORC Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BioFiber', 'description': 'Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold'}], 'classes': [{'categories': [{'measurements': [{'value': '80.7', 'spread': '18.9', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '43.8', 'ciLowerLimit': '37.4', 'ciUpperLimit': '50.1', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '22.2', 'groupDescription': 'Difference from baseline (6M-Baseline)', 'statisticalMethod': '2-sided, paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '6 Months', 'description': 'Evaluate clinical functional outcome WORC Index. This is a quality-of-life measurement specific for rotator cuff disease based on 21 questions answered using visual analog scales. It is organized in 5 subscales: physical symptoms, sprots/recreation, work, lifestyle, and emotions. Each item has a possible score from 0-100 where higher scores represent a lower quality of life. The scores are summed up to a possible 2100 points. The total number of points is subtracted from 2100, divided by 2100, then multiplied by 100 to create a percentage. The final score is thus a percentage ranging from 0 to 100 with higher percentages indicating better quality of life.', 'unitOfMeasure': 'Percentage of WORC Index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject is missing data for this outcome measure thus a total of 49 subjects were analyzed in this section.'}, {'type': 'SECONDARY', 'title': 'Clinical Functional Outcome - WORC Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BioFiber', 'description': 'Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold'}], 'classes': [{'categories': [{'measurements': [{'value': '86.8', 'spread': '16.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '49.2', 'ciLowerLimit': '43.2', 'ciUpperLimit': '55.2', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '20.2', 'groupDescription': 'Difference from baseline (12M-Baseline)', 'statisticalMethod': '2-sided, paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '12 Months', 'description': 'Evaluate clinical functional outcome WORC Index. This is a quality-of-life measurement specific for rotator cuff disease based on 21 questions answered using visual analog scales. It is organized in 5 subscales: physical symptoms, sprots/recreation, work, lifestyle, and emotions. Each item has a possible score from 0-100 where higher scores represent a lower quality of life. The scores are summed up to a possible 2100 points. The total number of points is subtracted from 2100, divided by 2100, then multiplied by 100 to create a percentage. The final score is thus a percentage ranging from 0 to 100 with higher percentages indicating better quality of life.', 'unitOfMeasure': 'Percentage of WORC Index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Study Participants With Re-tears', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BioFiber', 'description': 'Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 Months', 'description': 'Assess re-tears of the repaired tendon using ultrasound imaging. The definition of a re-tear for the rate reported is any full thickness tear in a tendon that was repaired with the BioFiber Scaffold that is at least 80% of the size of the original tear.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Study Participants With Re-tears', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BioFiber', 'description': 'Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 Months', 'description': 'Assess re-tears of the repaired tendon using ultrasound imaging. The definition of a re-tear for the rate reported is any full thickness tear in a tendon that was repaired with the BioFiber Scaffold that is at least 80% of the size of the original tear.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BioFiber Scaffold', 'description': 'Single arm of subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '50', 'numSubjects': '50'}]}, {'type': '6 Months Follow-up', 'achievements': [{'groupId': 'FG000', 'numUnits': '50', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '46', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '4', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}], 'typeUnitsAnalyzed': 'Single arm'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}, {'units': 'Arms', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'BioFiber', 'description': 'Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.2', 'spread': '6.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'denomUnitsSelected': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '27.9', 'spread': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}], 'typeUnitsAnalyzed': 'Arms'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-20', 'studyFirstSubmitDate': '2013-05-06', 'resultsFirstSubmitDate': '2016-11-29', 'studyFirstSubmitQcDate': '2013-05-06', 'lastUpdatePostDateStruct': {'date': '2017-06-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-20', 'studyFirstPostDateStruct': {'date': '2013-05-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Device Associated Adverse Events', 'timeFrame': '12 Months', 'description': "The primary objective is to report the number of participants with device associated adverse events.\n\nDevice associated adverse events are defined as adverse events that are classified as possibly or definitely related to the study product or procedure, or anticipated adverse events listed in the product's Instruction for Use regardless of relationship to the study device."}], 'secondaryOutcomes': [{'measure': 'Clinical Functional Outcome - Adjusted Constant-Murley Score', 'timeFrame': '6 Months', 'description': 'Evaluate clinical functional outcome Adjusted Constant-Murley Score. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient.\\[1\\] The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function. A score of 0 is considered the worst outcome and 100 is considered the best outcome.'}, {'measure': 'Clinical Functional Outcome - Adjusted Constant-Murley Score', 'timeFrame': '12 Month', 'description': 'Evaluate clinical functional outcome Adjusted Constant-Murley Score. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient.\\[1\\] The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function. A score of 0 is considered the worst outcome and 100 is considered the best outcome.'}, {'measure': 'Clinical Functional Outcome - WORC Index', 'timeFrame': '6 Months', 'description': 'Evaluate clinical functional outcome WORC Index. This is a quality-of-life measurement specific for rotator cuff disease based on 21 questions answered using visual analog scales. It is organized in 5 subscales: physical symptoms, sprots/recreation, work, lifestyle, and emotions. Each item has a possible score from 0-100 where higher scores represent a lower quality of life. The scores are summed up to a possible 2100 points. The total number of points is subtracted from 2100, divided by 2100, then multiplied by 100 to create a percentage. The final score is thus a percentage ranging from 0 to 100 with higher percentages indicating better quality of life.'}, {'measure': 'Clinical Functional Outcome - WORC Index', 'timeFrame': '12 Months', 'description': 'Evaluate clinical functional outcome WORC Index. This is a quality-of-life measurement specific for rotator cuff disease based on 21 questions answered using visual analog scales. It is organized in 5 subscales: physical symptoms, sprots/recreation, work, lifestyle, and emotions. Each item has a possible score from 0-100 where higher scores represent a lower quality of life. The scores are summed up to a possible 2100 points. The total number of points is subtracted from 2100, divided by 2100, then multiplied by 100 to create a percentage. The final score is thus a percentage ranging from 0 to 100 with higher percentages indicating better quality of life.'}, {'measure': 'Number of Study Participants With Re-tears', 'timeFrame': '6 Months', 'description': 'Assess re-tears of the repaired tendon using ultrasound imaging. The definition of a re-tear for the rate reported is any full thickness tear in a tendon that was repaired with the BioFiber Scaffold that is at least 80% of the size of the original tear.'}, {'measure': 'Number of Study Participants With Re-tears', 'timeFrame': '12 Months', 'description': 'Assess re-tears of the repaired tendon using ultrasound imaging. The definition of a re-tear for the rate reported is any full thickness tear in a tendon that was repaired with the BioFiber Scaffold that is at least 80% of the size of the original tear.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Full Thickness Rotator Cuff Tear']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to collect and report data from a consecutive series of patients implanted with these products as part of a post-market surveillance plan for CE Mark approval in the European Union.', 'detailedDescription': 'Rhe BioFiberTM Scaffold post-market surveillance study is a prospective, single arm, multi-center observational study with sites in the US and France.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Orthopedic referral clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 18 years of age or older\n\n * Patients with full thickness rotator cuff tears (confirmed at time of surgery) that are eligible for rotator cuff repair.\n * Patients willing and able to comply with the requirements of the study protocol and provide informed consent.\n\nExclusion Criteria:\n\n* Patients with active or latent infection\n* Patients with decreased vascularity\n* Patients with pathological soft tissue conditions\n* Patients with a known allergy or sensitivity to tetracycline hydrochloride or kanamycin sulfate\n* Patients with a known allergy or sensitivity to bovine collagen (BioFiber-CM only)\n* Participating in a concurrent study that has not been approved for concurrent enrollment by the Clinical Study Manager'}, 'identificationModule': {'nctId': 'NCT01849458', 'briefTitle': 'BioFiber Scaffold Post-Market Observational Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stryker Trauma and Extremities'}, 'officialTitle': 'BioFiber and BioFiber-CM Absorbable Biologic Scaffold for Soft Tissue Repair and Reinforcement Post-Market Surveillance Clinical Study', 'orgStudyIdInfo': {'id': 'Tornier 2013-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BioFiber', 'description': 'Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold', 'interventionNames': ['Device: BioFiber']}], 'interventions': [{'name': 'BioFiber', 'type': 'DEVICE', 'otherNames': ['BioFiber Scaffold', 'BioFiber-CM Scaffold'], 'description': 'Subjects implanted with BioFiber or BioFiber-CM Scaffold', 'armGroupLabels': ['BioFiber']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Insall Scott Kelly Institute', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia Sports Medicine and Shoulder Surgery', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'city': 'Saint-Grégoire', 'country': 'France', 'facility': 'St. Gregoire', 'geoPoint': {'lat': 48.15101, 'lon': -1.68579}}], 'overallOfficials': [{'name': 'Stephen Brockmeier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia'}, {'name': 'Timothy Reish, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Insall Scott Kelly Institute'}, {'name': 'Philippe Collin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Gregoire, France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stryker Trauma and Extremities', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}