Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 10:51 PM
Study NCT ID:
NCT01693367
Status:
TERMINATED
Last Update Posted:
2020-08-13
First Post:
2012-09-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Dynamic Locking Screws 5.0 vs. Standard Locking Screws in Fracture of Distal Femur Treated With Locked Plate Fixation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092524', 'term': 'Femoral Fractures, Distal'}, {'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D057068', 'term': 'Periprosthetic Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'andreas.faeh@aofoundation.org', 'phone': '0041 44 200 24 67', 'title': 'Clinical Operations Manager of Clinical Investigation and Documentation', 'organization': 'AO Foundation'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'DLS 5.0 (Dynamic Locking Screws)', 'description': 'ORIF with DLS 5.0 (Dynamic Locking Screws)\n\nDLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0', 'otherNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'SLS (Standard Locking Screw)', 'description': 'ORIF with SLS (Standard locking screw)\n\nSLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)', 'otherNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Western Ontario and McMaster Universities Index (WOMAC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DLS 5.0 (Dynamic Locking Screws)', 'description': 'ORIF with DLS 5.0 (Dynamic Locking Screws)\n\nDLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0'}, {'id': 'OG001', 'title': 'SLS (Standard Locking Screw)', 'description': 'ORIF with SLS (Standard locking screw)\n\nSLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)'}], 'timeFrame': '12 months after surgery', 'description': 'To assess pain, stiffness, and physical function', 'reportingStatus': 'POSTED', 'populationDescription': 'Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.'}, {'type': 'SECONDARY', 'title': 'Timed Up-and-go Test (TUG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DLS 5.0 (Dynamic Locking Screws)', 'description': 'ORIF with DLS 5.0 (Dynamic Locking Screws)\n\nDLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0'}, {'id': 'OG001', 'title': 'SLS (Standard Locking Screw)', 'description': 'ORIF with SLS (Standard locking screw)\n\nSLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)'}], 'timeFrame': '12 weeks ± 7 days, 6 months ± 30 days', 'description': 'The TUG measures the time (in seconds) that it takes for an individual to rise from an armchair (chair seat height = 45 cm / 1.5 feet), walk 3 meters (= 10 feet) to a line drawn on the floor, turn around and return to the chair. The time is measured from a seated position (back against the backrest) with a stopwatch started on the command "ready - go" and stopped when the seated position is reached again.', 'reportingStatus': 'POSTED', 'populationDescription': 'Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.'}, {'type': 'SECONDARY', 'title': 'Quality of Life (EuroQol-5D)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DLS 5.0 (Dynamic Locking Screws)', 'description': 'ORIF with DLS 5.0 (Dynamic Locking Screws)\n\nDLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0'}, {'id': 'OG001', 'title': 'SLS (Standard Locking Screw)', 'description': 'ORIF with SLS (Standard locking screw)\n\nSLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)'}], 'timeFrame': 'Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery', 'reportingStatus': 'POSTED', 'populationDescription': 'Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.'}, {'type': 'SECONDARY', 'title': 'Range of Motion (ROM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DLS 5.0 (Dynamic Locking Screws)', 'description': 'ORIF with DLS 5.0 (Dynamic Locking Screws)\n\nDLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0'}, {'id': 'OG001', 'title': 'SLS (Standard Locking Screw)', 'description': 'ORIF with SLS (Standard locking screw)\n\nSLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)'}], 'timeFrame': '6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery', 'description': 'Assessment of passive ROM of the knee (flexion - extension)', 'reportingStatus': 'POSTED', 'populationDescription': 'Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.'}, {'type': 'SECONDARY', 'title': 'Full Weight-bearing Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DLS 5.0 (Dynamic Locking Screws)', 'description': 'ORIF with DLS 5.0 (Dynamic Locking Screws)\n\nDLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0'}, {'id': 'OG001', 'title': 'SLS (Standard Locking Screw)', 'description': 'ORIF with SLS (Standard locking screw)\n\nSLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)'}], 'timeFrame': 'weekly measurement at home', 'description': 'Assessment of the timepoint when the patient :\n\n* can bear the whole body weight on the affected leg at single-leg-stance for 3 seconds\n* can walk without walking aid\n* has no intake of analgesics\n* has a pain level experienced at the fracture site during weight bearing over two consecutive measurements with a value of ≤ 3 as measured on a 0-10 numeric rating scale (NRS), where 0 = no pain and 10 = worst pain imaginable', 'reportingStatus': 'POSTED', 'populationDescription': 'Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.'}, {'type': 'SECONDARY', 'title': 'WOMAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DLS 5.0 (Dynamic Locking Screws)', 'description': 'ORIF with DLS 5.0 (Dynamic Locking Screws)\n\nDLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0'}, {'id': 'OG001', 'title': 'SLS (Standard Locking Screw)', 'description': 'ORIF with SLS (Standard locking screw)\n\nSLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)'}], 'timeFrame': 'Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery', 'description': 'To assess pain, stiffness, and physical function', 'reportingStatus': 'POSTED', 'populationDescription': 'Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DLS 5.0 (Dynamic Locking Screws)', 'description': 'ORIF with DLS 5.0 (Dynamic Locking Screws)\n\nDLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0'}, {'id': 'FG001', 'title': 'SLS (Standard Locking Screw)', 'description': 'ORIF with SLS (Standard locking screw)\n\nSLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The multicenter international study enrolled patients with distal femur fractures which were either stabilize with a Dynamic Locking Screw or a standard locking screw. The study was stopped due to implant breakages observed after planned implant removals in non-study patients treated with the DLS 5.0mm.', 'preAssignmentDetails': 'Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'DLS 5.0 (Dynamic Locking Screws)', 'description': 'ORIF with DLS 5.0 (Dynamic Locking Screws)\n\nDLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0'}, {'id': 'BG001', 'title': 'SLS (Standard Locking Screw)', 'description': 'ORIF with SLS (Standard locking screw)\n\nSLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.5', 'groupId': 'BG000', 'lowerLimit': '52', 'upperLimit': '85'}, {'value': '55', 'groupId': 'BG001', 'lowerLimit': '23', 'upperLimit': '71'}, {'value': '60.4', 'groupId': 'BG002', 'lowerLimit': '23', 'upperLimit': '85'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Switzerland', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Study was stopped'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'The medical device has been withdrawn from the market due to technical issues.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-11', 'studyFirstSubmitDate': '2012-09-20', 'resultsFirstSubmitDate': '2016-04-08', 'studyFirstSubmitQcDate': '2012-09-24', 'lastUpdatePostDateStruct': {'date': '2020-08-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-05-24', 'studyFirstPostDateStruct': {'date': '2012-09-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Western Ontario and McMaster Universities Index (WOMAC)', 'timeFrame': '12 months after surgery', 'description': 'To assess pain, stiffness, and physical function'}], 'secondaryOutcomes': [{'measure': 'Timed Up-and-go Test (TUG)', 'timeFrame': '12 weeks ± 7 days, 6 months ± 30 days', 'description': 'The TUG measures the time (in seconds) that it takes for an individual to rise from an armchair (chair seat height = 45 cm / 1.5 feet), walk 3 meters (= 10 feet) to a line drawn on the floor, turn around and return to the chair. The time is measured from a seated position (back against the backrest) with a stopwatch started on the command "ready - go" and stopped when the seated position is reached again.'}, {'measure': 'Quality of Life (EuroQol-5D)', 'timeFrame': 'Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery'}, {'measure': 'Range of Motion (ROM)', 'timeFrame': '6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery', 'description': 'Assessment of passive ROM of the knee (flexion - extension)'}, {'measure': 'Full Weight-bearing Status', 'timeFrame': 'weekly measurement at home', 'description': 'Assessment of the timepoint when the patient :\n\n* can bear the whole body weight on the affected leg at single-leg-stance for 3 seconds\n* can walk without walking aid\n* has no intake of analgesics\n* has a pain level experienced at the fracture site during weight bearing over two consecutive measurements with a value of ≤ 3 as measured on a 0-10 numeric rating scale (NRS), where 0 = no pain and 10 = worst pain imaginable'}, {'measure': 'WOMAC', 'timeFrame': 'Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery', 'description': 'To assess pain, stiffness, and physical function'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Femoral fracture', 'Periprosthetic fracture', 'Fracture fixation, internal', 'Distal femur fractures', 'Dynamic Locking Screw', 'WOMAC'], 'conditions': ['Distal Femur Fractures']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the performance of Dynamic Locking Screws (DLS) used to stabilize the shaft component of distal femur fractures in comparison to standard locking screws (SLS). The hypothesis is that DLS will lead to better functional outcomes (WOMAC score) due to increased and more symmetrical callus formation and fewer non-unions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 21 years and older\n* Closed or open distal femur fracture (AO 33 A1-3, 33 C1-3) including distal femur fractures above a total knee arthroplasty\n* Ability to walk independently prior to injury\n* Eligible for treatment with ORIF of the distal femur with a large fragment locking plate (LISS, LCP)\n* Willing and able to comply with post-operative protocol and return for follow-up.\n* Ability to understand the content of the patient information / informed consent form and participate in the clinical investigation\n* Signed informed consent\n\nExclusion Criteria:\n\n* Additional ipsi- or contralateral lower extremity fracture\n* Any kind of implant at the ipsilateral proximal femur\n* Pre-existing malunion or nonunion of the ipsilateral lower extremity\n* Segmental bone defect requiring bone grafting\n* More than 4 weeks between injury and surgery\n* Pathologic fracture due to a disease other than osteoporosis (eg, tumor, metastasis)\n* Polytrauma\n* Active malignancy\n* Any not medically managed severe systemic disease\n* Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment\n* Pregnancy or women planning to conceive within the study period\n* Prisoner\n* Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study'}, 'identificationModule': {'nctId': 'NCT01693367', 'briefTitle': 'Dynamic Locking Screws 5.0 vs. Standard Locking Screws in Fracture of Distal Femur Treated With Locked Plate Fixation', 'organization': {'class': 'OTHER', 'fullName': 'AO Innovation Translation Center'}, 'officialTitle': 'A Multi-Center Randomized Controlled Pilot Study of Dynamic Locking Screws 5.0 vs. Standard Locking Screws in Fracture of Distal Femur Treated With Locked Plate Fixation', 'orgStudyIdInfo': {'id': 'DLS 5.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'DLS 5.0 (Dynamic Locking Screws)', 'description': 'ORIF with DLS 5.0 (Dynamic Locking Screws)', 'interventionNames': ['Device: DLS 5.0 (Dynamic locking screws)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SLS (Standard locking screw)', 'description': 'ORIF with SLS (Standard locking screw)', 'interventionNames': ['Device: SLS (Standard locking screw)']}], 'interventions': [{'name': 'DLS 5.0 (Dynamic locking screws)', 'type': 'DEVICE', 'description': 'Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0', 'armGroupLabels': ['DLS 5.0 (Dynamic Locking Screws)']}, {'name': 'SLS (Standard locking screw)', 'type': 'DEVICE', 'description': 'Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)', 'armGroupLabels': ['SLS (Standard locking screw)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '65212', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri Orthopaedics', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University Orthopedics', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Harborview Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Vienna', 'country': 'Austria', 'facility': 'Wilhelminenspital', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité Berlin, Campus Virchow Klinikum', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '66421', 'city': 'Homburg', 'country': 'Germany', 'facility': 'Universitätsklinikum des Saarlandes', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}, {'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'BGU Tübingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': '7000', 'city': 'Chur', 'country': 'Switzerland', 'facility': 'Cantonal Hospital Chur', 'geoPoint': {'lat': 46.84986, 'lon': 9.53287}}, {'zip': '6000', 'city': 'Lucerne', 'country': 'Switzerland', 'facility': 'Luzerner Kantonsspital', 'geoPoint': {'lat': 47.05048, 'lon': 8.30635}}, {'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Universitätsspital Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Michael J. Gardner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}, {'name': 'Sean E. Nork, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AO Innovation Translation Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}