Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-03-01 @ 9:55 PM
Study NCT ID:
NCT02456194
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2015-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Management of Traumatic Bone Defects in Tibial Plateau Fractures With Antibiotic-Impregnated Biodegradable Calcium Sulfate Beads: A Prospective Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013978', 'term': 'Tibial Fractures'}, {'id': 'D057072', 'term': 'Intra-Articular Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005593', 'term': 'Fracture Fixation, Internal'}], 'ancestors': [{'id': 'D005592', 'term': 'Fracture Fixation'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Ross.Leighton@nshealth.ca', 'phone': '1-902-473-4035', 'title': 'Ross Leighton', 'organization': 'NSHA'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Calcium Sulfate + Antibiotics + Internal Fixation', 'description': "Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.", 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 6, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Infection', 'notes': 'Treated with irrigation and debridement and antibiotics', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'intra-articular heterotopic bone formation', 'notes': 'debrided arthroscopically', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hardware irritation', 'notes': 'treated with revision to smaller plate or removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'articular surface apoptosis', 'notes': 'Theparticipant had healed their fracture by three months but had articular surface apoptosis by six months following the initial fracture and was revised to a total knee replacement at nine months and went on to heal uneventfully.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Resorption of Study Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcium Sulfate + Antibiotics + Internal Fixation', 'description': "Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. 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Choice of antibiotic is left to the surgeon's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '89.0', 'spread': '18.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Range of Motion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcium Sulfate + Antibiotics + Internal Fixation', 'description': "Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '97.38', 'spread': '27.42', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Range of knee motion (active flexion) in degrees', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subsidence of Joint Surface', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcium Sulfate + Antibiotics + Internal Fixation', 'description': "Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks, 3 months, 6 months, 12 months', 'description': 'Amount of collapse of the joint surface, measured in mm, on plain x-ray. Reported as number of participants with at least 2mm of subsidence on x-ray.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Knee Injury Osteoarthritis Outcome Score - Pain Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcium Sulfate + Antibiotics + Internal Fixation', 'description': "Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. 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Choice of antibiotic is left to the surgeon's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '35.83', 'spread': '23.93', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcium Sulfate + Antibiotics + Internal Fixation', 'description': "Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. 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Choice of antibiotic is left to the surgeon's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '58.98', 'spread': '23.47', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Range of Motion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcium Sulfate + Antibiotics + Internal Fixation', 'description': "Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '108.52', 'spread': '25.35', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Range of knee motion (active flexion) in degrees', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Range of Motion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcium Sulfate + Antibiotics + Internal Fixation', 'description': "Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '121.20', 'spread': '19.98', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Range of knee motion (active flexion) in degrees', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Range of Motion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcium Sulfate + Antibiotics + Internal Fixation', 'description': "Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '126.51', 'spread': '11.87', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Range of knee motion (active flexion) in degrees', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Resorption of Study Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcium Sulfate + Antibiotics + Internal Fixation', 'description': "Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': 'Number of participants with any study device remaining visible on x-ray', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Resorption of Study Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcium Sulfate + Antibiotics + Internal Fixation', 'description': "Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Number of participants with any study device remaining visible on x-ray', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Resorption of Study Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcium Sulfate + Antibiotics + Internal Fixation', 'description': "Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Number of participants with any study device remaining visible on x-ray', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Calcium Sulfate + Antibiotics + Internal Fixation', 'description': "Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Calcium Sulfate + Antibiotics + Internal Fixation', 'description': "Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '53.3', 'spread': '12.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', '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': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-31', 'size': 370810, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-11-08T13:10', 'hasProtocol': True}, {'date': '2015-07-16', 'size': 369589, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-11-08T13:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-10', 'studyFirstSubmitDate': '2015-05-26', 'resultsFirstSubmitDate': '2022-11-10', 'studyFirstSubmitQcDate': '2015-05-26', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-11-10', 'studyFirstPostDateStruct': {'date': '2015-05-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resorption of Study Device', 'timeFrame': '6 months', 'description': 'Number of participants with any study device remaining visible on CT'}], 'secondaryOutcomes': [{'measure': 'Knee Injury Osteoarthritis Outcome Score - Pain Subscale', 'timeFrame': 'Baseline', 'description': 'Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.'}, {'measure': 'Range of Motion', 'timeFrame': '6 weeks', 'description': 'Range of knee motion (active flexion) in degrees'}, {'measure': 'Subsidence of Joint Surface', 'timeFrame': '6 weeks, 3 months, 6 months, 12 months', 'description': 'Amount of collapse of the joint surface, measured in mm, on plain x-ray. Reported as number of participants with at least 2mm of subsidence on x-ray.'}, {'measure': 'Knee Injury Osteoarthritis Outcome Score - Pain Subscale', 'timeFrame': '6 weeks', 'description': 'Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.'}, {'measure': 'Knee Injury Osteoarthritis Outcome Score - Pain Subscale', 'timeFrame': '3 months', 'description': 'Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.'}, {'measure': 'Knee Injury Osteoarthritis Outcome Score - Pain Subscale', 'timeFrame': '6 months', 'description': 'Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.'}, {'measure': 'Knee Injury Osteoarthritis Outcome Score - Pain Subscale', 'timeFrame': '12 months', 'description': 'Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.'}, {'measure': 'Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale', 'timeFrame': 'Baseline', 'description': 'Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.'}, {'measure': 'Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale', 'timeFrame': '6 weeks', 'description': 'Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.'}, {'measure': 'Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale', 'timeFrame': '6 months', 'description': 'Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.'}, {'measure': 'Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale', 'timeFrame': '3 months', 'description': 'Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.'}, {'measure': 'Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale', 'timeFrame': '12 months', 'description': 'Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.'}, {'measure': 'Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale', 'timeFrame': 'Baseline', 'description': 'Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.'}, {'measure': 'Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale', 'timeFrame': '6 weeks', 'description': 'Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.'}, {'measure': 'Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale', 'timeFrame': '3 months', 'description': 'Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.'}, {'measure': 'Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale', 'timeFrame': '6 months', 'description': 'Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.'}, {'measure': 'Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale', 'timeFrame': '12 months', 'description': 'Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.'}, {'measure': 'Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale', 'timeFrame': 'Baseline', 'description': 'Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.'}, {'measure': 'Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale', 'timeFrame': '6 weeks', 'description': 'Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.'}, {'measure': 'Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale', 'timeFrame': '3 months', 'description': 'Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.'}, {'measure': 'Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale', 'timeFrame': '6 months', 'description': 'Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.'}, {'measure': 'Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale', 'timeFrame': '12 months', 'description': 'Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.'}, {'measure': 'Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale', 'timeFrame': 'Baseline', 'description': 'Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.'}, {'measure': 'Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale', 'timeFrame': '6 weeks', 'description': 'Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.'}, {'measure': 'Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale', 'timeFrame': '3 months', 'description': 'Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.'}, {'measure': 'Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale', 'timeFrame': '6 months', 'description': 'Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.'}, {'measure': 'Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale', 'timeFrame': '12 months', 'description': 'Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.'}, {'measure': 'Range of Motion', 'timeFrame': '3 months', 'description': 'Range of knee motion (active flexion) in degrees'}, {'measure': 'Range of Motion', 'timeFrame': '6 months', 'description': 'Range of knee motion (active flexion) in degrees'}, {'measure': 'Range of Motion', 'timeFrame': '12 months', 'description': 'Range of knee motion (active flexion) in degrees'}, {'measure': 'Resorption of Study Device', 'timeFrame': '3 months', 'description': 'Number of participants with any study device remaining visible on x-ray'}, {'measure': 'Resorption of Study Device', 'timeFrame': '6 months', 'description': 'Number of participants with any study device remaining visible on x-ray'}, {'measure': 'Resorption of Study Device', 'timeFrame': '12 months', 'description': 'Number of participants with any study device remaining visible on x-ray'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Tibial Fractures', 'Intra-Articular Fractures', 'Fracture Fixation, Internal']}, 'descriptionModule': {'briefSummary': 'This is a prospective clinical trial of tibial plateau fractures treated with internal fixation and a calcium sulfate graft which can be mixed with antibiotics and molded into various bead sizes for implantation into bone defects. The graft material chosen for this study is STIMULAN Rapid Cure (Biocomposites, UK), which is approved for use as a bone void filler and may be mixed with a variety of antibiotics. The combination of STIMULAN + antibiotic in bead form is the "study device".\n\nOur primary study aim is to look at resorption and remodeling of the study device into bone. Another important aim of the study is to look at subsidence, or collapse, of the joint surface.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (skeletally mature) men or women;\n* Acute, closed, tibial plateau fractures, Schatzker grade 1 through 5;\n* Internal fixation and use of study device per protocol;\n* Fracture repair within 30 days of injury;\n* Signed informed consent to participate in study.\n\nExclusion Criteria:\n\n* Uncontrolled diabetes;\n* Severe degenerative or metabolic bone disease;\n* Malignancy;\n* Severe vascular or neurologic disease;\n* Alcoholism;\n* Substance abuse;\n* Use of systemic steroids;\n* Immunosuppressive therapy;\n* Hypercalcaemia;\n* Renal-compromised patients;\n* Osteomyelitis or chronic infection in the study limb;\n* Women who are pregnant or breast-feeding.'}, 'identificationModule': {'nctId': 'NCT02456194', 'briefTitle': 'Management of Traumatic Bone Defects in Tibial Plateau Fractures With Antibiotic-Impregnated Biodegradable Calcium Sulfate Beads: A Prospective Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Nova Scotia Health Authority'}, 'orgStudyIdInfo': {'id': 'RL007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Calcium Sulfate + Antibiotics + Internal Fixation', 'interventionNames': ['Device: Calcium Sulfate + Antibiotics + Internal Fixation']}], 'interventions': [{'name': 'Calcium Sulfate + Antibiotics + Internal Fixation', 'type': 'DEVICE', 'otherNames': ['STIMULAN Rapid Cure'], 'description': "STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.", 'armGroupLabels': ['Calcium Sulfate + Antibiotics + Internal Fixation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 1N4', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Alberta Health Services', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'E1C6Z8', 'city': 'Moncton', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'Horizon Health Network', 'geoPoint': {'lat': 46.09454, 'lon': -64.7965}}, {'zip': 'A1C5S7', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'Memorial University of Newfoundland', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'B3h 1V7', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Halifax Infirmary', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'H4J1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hopital du Sacre-Coeur de Montreal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Ross Leighton, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nova Scotia Health Authority'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ross Leighton', 'class': 'OTHER'}, 'collaborators': [{'name': 'Biocomposites Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Orthopaedic Surgeon', 'investigatorFullName': 'Ross Leighton', 'investigatorAffiliation': 'Nova Scotia Health Authority'}}}}