Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2026-01-01 @ 4:21 PM
Study NCT ID:
NCT01246895
Status:
COMPLETED
Last Update Posted:
2018-01-24
First Post:
2010-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Follow-Up Study Evaluating The Long Term Safety and Efficacy of BST-CarGel and Microfracture Repair of the Knee
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D015775', 'term': 'Fractures, Stress'}], 'ancestors': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'david.castelo@piramal.com', 'phone': '450-686-2437', 'title': 'David Castelo, Clinical Research Manager', 'phoneExt': '313', 'organization': 'Piramal Healthcare (Canada) Limited - Bio-Orthopaedics Division'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Since the sample size was not predetermined, the statistical methods were used in a conditional fashion such that those that were determined to be invalid or inappropriate upon data review were discarded or replaced by more appropriate analyses.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events collected from signature of ICF (follow-up study) to 5 year follow-up.', 'description': 'The incidence of AEs, SAEs, and incidents have been summarized by SOC and preferred terms according to MedDRA preferred terminology for each treatment group, frequency, maximum severity, and relationship to procedure or device.', 'eventGroups': [{'id': 'EG000', 'title': 'Microfracture + BST-CarGel', 'description': 'Microfracture with BST-CarGel', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 2, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Microfracture Alone', 'description': 'Microfracture without BST-CarGel', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 3, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'LEFT KNEE THROBBING PAIN', 'notes': 'Unanticipated procedure/device-related. Preferred Term: Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'LEFT KNEE MEDIAL CLICKING THAT INITIATES THROBBING', 'notes': 'Unanticipated procedure/device-related. Preferred Term: Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'PAIN LEFT KNEE/ ABOVE KNEE CAP', 'notes': 'Anticipated procedure-related. Preferred Term: Arthralgia.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'FEELING OF RIGHT KNEE GIVING OUT', 'notes': 'Anticipated procedure-related. Preferred Term: Arthralgia.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'RIGHT KNEE PAIN AFTER EXERCISE', 'notes': 'Anticipated procedure-related. Preferred Term: Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'MIGRAINES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'seriousEvents': [{'term': 'Breast Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Degree of Lesion Filling (%Fill) by Repair Tissue at Degree of Lesion Filling (%Fill) by Repair Tissue at 5 Years Through MRI.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Microfracture + BST-CarGel', 'description': 'Microfracture with BST-CarGel'}, {'id': 'OG001', 'title': 'Microfracture Alone', 'description': 'Microfracture without BST-CarGel'}], 'classes': [{'categories': [{'measurements': [{'value': '93.79', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '86.96', 'spread': '2.85', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.017', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.', 'statisticalMethod': 'general estimating equations (GEE)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '5 years', 'description': 'Degree of lesion filling (repair tissue volume) as measured by quantitative MRI at 5 Years post-treatment compared to the debrided lesion 1-month post-treatment (baseline).', 'unitOfMeasure': 'Percentage of lesion filled (%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '33 out of 34 BST-CarGel with percentage lesion filled measurement. 1 aberrant imaging datapoint from 1 patient out of 34 patients was removed from the Experimental group'}, {'type': 'PRIMARY', 'title': 'Repair Tissue Quality (T2 MRI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Microfracture + BST-CarGel', 'description': 'Microfracture with BST-CarGel'}, {'id': 'OG001', 'title': 'Microfracture Alone', 'description': 'Microfracture without BST-CarGel'}], 'classes': [{'categories': [{'measurements': [{'value': '75.68', 'spread': '5.25', 'groupId': 'OG000'}, {'value': '90.41', 'spread': '6.56', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.026', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.', 'statisticalMethod': 'general estimating equations (GEE)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '5 years', 'description': 'Tissue quality of the repair tissue as measured by T2 MRI as an index for collagen-based structure.', 'unitOfMeasure': 'T2 relaxation time (ms)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '5 aberrant imaging datapoint from 5 patients out of 34 patients were removed from the Experimental group and 4 aberrant imaging datapoint from 4 patients out of 34 patients were removed from the Control group'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline for Knee-related Pain, Stiffness and Function at 5 Years (WOMAC Parts A, B, C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Microfracture + BST-CarGel', 'description': 'Microfracture with BST-CarGel'}, {'id': 'OG001', 'title': 'Microfracture Alone', 'description': 'Microfracture without BST-CarGel'}], 'classes': [{'title': 'Pain at 5 year', 'categories': [{'measurements': [{'value': '-15.37', 'spread': '1.47', 'groupId': 'OG000'}, {'value': '-16.56', 'spread': '1.19', 'groupId': 'OG001'}]}]}, {'title': 'Stiffness at 5 year', 'categories': [{'measurements': [{'value': '-5.63', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '-6.68', 'spread': '0.58', 'groupId': 'OG001'}]}]}, {'title': 'Physical Function at 5 year', 'categories': [{'measurements': [{'value': '-56.52', 'spread': '4.57', 'groupId': 'OG000'}, {'value': '-62.10', 'spread': '3.43', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.474', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.', 'groupDescription': 'WOMAC subscale - Pain', 'statisticalMethod': 'general estimating equations (GEE)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.'}, {'pValue': '0.236', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.', 'groupDescription': 'WOMAC subscale - Stiffness', 'statisticalMethod': 'general estimating equations (GEE)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.'}, {'pValue': '0.326', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.', 'groupDescription': 'WOMAC subscale - Physical function', 'statisticalMethod': 'general estimating equations (GEE)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '5 years', 'description': 'The three sub-scales: 1) Pain, 2.) stiffness and 3.) function scores ranged from 0-10. Pain had 5 items and stiffness had 2 items, and function had 17 items. The total score for pain ranged from 0 no pain to 50 worst pain. The total score for stiffness ranged from 0 no stiffness to 20 worst stiffness. The total score for function raged from 0 no function to 170 worst function. A higher score indicates a better health state improvement.', 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 datapoint not made available from 1 patient out of 34 patients in the Experimental group'}, {'type': 'SECONDARY', 'title': 'The Number of Participants With Adverse Events Until 5 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Microfracture + BST-CarGel', 'description': 'Microfracture with BST-CarGel'}, {'id': 'OG001', 'title': 'Microfracture Alone', 'description': 'Microfracture without BST-CarGel'}], 'classes': [{'title': "Participants with AE's", 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Participants with unanticipated procedure-related', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Participants with anticipated procedure-related AE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Participants with unanticipated device-related AEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Participants with anticipated device-related AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Participants with serious adverse events SAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Participants discontinued from study because of an', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Participant death over the 5-year follow up period', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Physical count', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'Safety was assessed by recording the number of participants with Adverse Events (AEs) and their severity from the time of ICF signing up to 5 years post-treatment.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who experienced adverse events'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage Change in Quality of Life Assessed Using the SF-36 Questionnaire.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expiremental', 'description': 'Microfracture with BST-CarGel'}, {'id': 'OG001', 'title': 'Control', 'description': 'Microfracture without BST-CarGel'}], 'classes': [{'title': 'Physical component - Year 1', 'categories': [{'measurements': [{'value': '13.01', 'spread': '1.43', 'groupId': 'OG000'}, {'value': '14.37', 'spread': '1.35', 'groupId': 'OG001'}]}]}, {'title': 'Physical component - Year 5', 'categories': [{'measurements': [{'value': '13.12', 'spread': '1.63', 'groupId': 'OG000'}, {'value': '14.48', 'spread': '1.42', 'groupId': 'OG001'}]}]}, {'title': 'Mental component - Year 1', 'categories': [{'measurements': [{'value': '3.38', 'spread': '1.42', 'groupId': 'OG000'}, {'value': '0.49', 'spread': '1.42', 'groupId': 'OG001'}]}]}, {'title': 'Mental component - Year 5', 'categories': [{'measurements': [{'value': '2.72', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '-0.17', 'spread': '1.76', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.478', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.', 'groupDescription': 'SF-36 v2 Physical component', 'statisticalMethod': 'general estimating equations (GEE)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.'}, {'pValue': '0.125', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.', 'groupDescription': 'SF-36 v2 Mental component', 'statisticalMethod': 'general estimating equations (GEE)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '1 and 5 years', 'description': 'SF-36 v2 includes 2 aggregate measures-Physical and Mental components-derived from 8 subscales. Least squares means are adjusted for baseline. Higher positive scores indicate better results. Scoring ranges from 0 to 100%.', 'unitOfMeasure': 'Percent change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Microfracture + BST-CarGel', 'description': 'Microfracture with BST-CarGel'}, {'id': 'FG001', 'title': 'Microfracture Alone', 'description': 'Microfracture without BST-CarGel'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'All eligible subjects who were treated under Protocol CG-CIP01-P and completed the required 12-month follow-up period were asked to participate in this follow-up study. Ultimately, 67 subjects signed an ICF to enter the study and the screening process.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental', 'description': 'Microfracture with BST-CarGel'}, {'id': 'BG001', 'title': 'Control', 'description': 'Microfracture without BST-CarGel'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.3', 'spread': '9.7', 'groupId': 'BG000'}, {'value': '40.1', 'spread': '10.1', 'groupId': 'BG001'}, {'value': '36.8', 'spread': '10.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': 'Withdrew/Withdrawn', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Sample size determination for the 1-year trial was previously reported. All treated participants who enrolled in the extension study were included in the efficacy analyses, which were performed according to a preapproved statistical analysis plan.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-06', 'studyFirstSubmitDate': '2010-11-22', 'resultsFirstSubmitDate': '2016-01-07', 'studyFirstSubmitQcDate': '2010-11-22', 'lastUpdatePostDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-06', 'studyFirstPostDateStruct': {'date': '2010-11-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage Change in Quality of Life Assessed Using the SF-36 Questionnaire.', 'timeFrame': '1 and 5 years', 'description': 'SF-36 v2 includes 2 aggregate measures-Physical and Mental components-derived from 8 subscales. Least squares means are adjusted for baseline. Higher positive scores indicate better results. Scoring ranges from 0 to 100%.'}], 'primaryOutcomes': [{'measure': 'Degree of Lesion Filling (%Fill) by Repair Tissue at Degree of Lesion Filling (%Fill) by Repair Tissue at 5 Years Through MRI.', 'timeFrame': '5 years', 'description': 'Degree of lesion filling (repair tissue volume) as measured by quantitative MRI at 5 Years post-treatment compared to the debrided lesion 1-month post-treatment (baseline).'}, {'measure': 'Repair Tissue Quality (T2 MRI)', 'timeFrame': '5 years', 'description': 'Tissue quality of the repair tissue as measured by T2 MRI as an index for collagen-based structure.'}], 'secondaryOutcomes': [{'measure': 'Percentage Change From Baseline for Knee-related Pain, Stiffness and Function at 5 Years (WOMAC Parts A, B, C)', 'timeFrame': '5 years', 'description': 'The three sub-scales: 1) Pain, 2.) stiffness and 3.) function scores ranged from 0-10. Pain had 5 items and stiffness had 2 items, and function had 17 items. The total score for pain ranged from 0 no pain to 50 worst pain. The total score for stiffness ranged from 0 no stiffness to 20 worst stiffness. The total score for function raged from 0 no function to 170 worst function. A higher score indicates a better health state improvement.'}, {'measure': 'The Number of Participants With Adverse Events Until 5 Years', 'timeFrame': '5 years', 'description': 'Safety was assessed by recording the number of participants with Adverse Events (AEs) and their severity from the time of ICF signing up to 5 years post-treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cartilage repair', 'Cartilage', 'Knee', 'Knee Pain', 'Microfracture', 'Arthroscopy', 'Bone Marrow Stimulation', 'Chondrogenesis', 'Scaffold', 'Chitosan', 'Articular Cartilage Repair'], 'conditions': ['Knee Injuries']}, 'referencesModule': {'references': [{'pmid': '26069709', 'type': 'RESULT', 'citation': 'Shive MS, Stanish WD, McCormack R, Forriol F, Mohtadi N, Pelet S, Desnoyers J, Methot S, Vehik K, Restrepo A. BST-CarGel(R) Treatment Maintains Cartilage Repair Superiority over Microfracture at 5 Years in a Multicenter Randomized Controlled Trial. Cartilage. 2015 Apr;6(2):62-72. doi: 10.1177/1947603514562064.'}]}, 'descriptionModule': {'briefSummary': 'This follow-up study will evaluate the effects of BST-CarGel® application to a microfractured lesion (investigational) and microfracture alone (control) for up to 5 years from treatment in subjects, treated under Protocols CG-CIP01-P and CG-CIP02-P, and will serve as a post approval study for these Protocols, in support of a commercial application. The lesions treated under Protocols CG-CIP01-P and CG-CIP02-P were focal lesions of articular cartilage, grade 3 or 4 (either ICRS or Outerbridge classification) on the medial and lateral femoral condyles of the knee, and were classified as either acute or chronic.', 'detailedDescription': "Cartilage repair currently remains a problematic orthopedic concern with no effective solution. The development of new surgical techniques or therapies is critical in meeting this medical need.\n\nClinical data regarding the long-term durability of repair tissue resulting from cartilage repair techniques such as microfracture, autologous chondrocyte implantation or mosaicplasty is lacking. Only two studies, one comparative and one uncontrolled, have examined long-term repair outcomes (over 4 years). These studies reinforced the concept that further studies are needed to identify a technique or product that will lead to long-term clinical benefit through improved cartilage repair efficacy.\n\nBST-CarGel® is a medical device derived from chitosan applied to a microfractured lesion and has been shown to promote the quantity and quality of cartilage repair tissue in animals. The efficacy and safety of BST-CarGel® is currently being evaluated in humans as compared to the standard of care treatment, microfracture, in a 12 month international study in Canada, Europe and Korea under Protocols CG-CIP01-P and CG-CIP02-P. When these protocols were designed and carried out, the BST-CarGel® technology belonged to BioSyntech Canada Inc. Afterwards, the technology was acquired by Piramal Healthcare (Canada) Ltd. which is now the owner of the technology and the sponsor for this Extension Study CG-C1P04.\n\nThis follow-up study will evaluate the long-term effects (5 yrs) of BST-CarGel® + microfracture and microfracture alone in subjects treated in the pivotal and sub-studies.\n\nAll eligible subjects (maximum 80) who were treated under Protocols CG-CIP01-P and CG-CIP02-P and completed the required 12 month follow-up period will be asked to participate in this follow-up study.\n\nThe stratification from Protocols CG-CIP01-P and CG-CIP02-P (investigational site and lesion type) will be retained for the purposes of the follow-up study, and all third parties such as the MRI central reading facility will remain blinded to the treatment received under Protocols CG-CIP01-P and CG-CIP02-P.\n\nComparisons between the two treatment groups will be performed.\n\nThe following assessments will be done annually at years 3 and/or 4 and 5 post -treatment under Protocols CG-CIP01-P and CG-CIP02-P in subjects treated with BST-CarGel + microfracture or microfracture alone:\n\n1. Analyses of tissue repair will be carried out based on the degree of lesion filling and quality of repair tissue using MRI\n2. The general health status of subjects will be captured in the case report form (CRF) and will include the subject's overall health status, treated knee status, adverse events (AEs) and concomitant medications.\n3. The assessment of the subject's knee pain, stiffness, functional ability and quality of life through self-assessment questionnaires (Western Ontario and McMaster Universities osteoarthritis index (WOMAC) and short-form-36 (SF-36v2)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients that have been treated under either protocol CG-CIP01 or CG-CIP02', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subject was treated under Protocol CG-CIP01 or CG-CIP02 and completed 12 month follow-up period\n* The subject has understood and signed a Research Ethics Board(REB) approved Informed Consent Form (ICF)\n\nExclusion Criteria:\n\n* The subject was not treated under Protocol CG-CIP01-P or CG-CIP02-P\n* The subject did not complete 12 month follow-up period'}, 'identificationModule': {'nctId': 'NCT01246895', 'briefTitle': 'Follow-Up Study Evaluating The Long Term Safety and Efficacy of BST-CarGel and Microfracture Repair of the Knee', 'organization': {'class': 'INDUSTRY', 'fullName': 'Piramal Healthcare Canada Ltd'}, 'officialTitle': 'Follow-up Study Evaluating The Long-Term Safety and Efficacy of BST-CarGel® and Microfracture In Repair of Focal Articular Cartilage Lesions on The Femoral Condyle (Extension Study of Protocols CG-CIP01-P & CG-CIP02-P)', 'orgStudyIdInfo': {'id': 'CG-CIP04-P'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experimental', 'description': 'Microfracture with BST-CarGel', 'interventionNames': ['Device: Microfracture with BST-CarGel']}, {'label': 'Control', 'description': 'Microfracture without BST-CarGel', 'interventionNames': ['Device: Microfracture without BST-CarGel']}], 'interventions': [{'name': 'Microfracture with BST-CarGel', 'type': 'DEVICE', 'armGroupLabels': ['Experimental']}, {'name': 'Microfracture without BST-CarGel', 'type': 'DEVICE', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 1N4', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Calgary Sports Medicine Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'V3L 3W7', 'city': 'New Westminster', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Simon Fraser Orthopaedic Fund, Royal Columbian Hospital', 'geoPoint': {'lat': 49.20678, 'lon': -122.91092}}, {'zip': 'V6T 2B5', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Joint Preservation Centre of British Columbia', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'R3M 3E4', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Pan Am Clinic', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'B3H 4M2', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Orthopaedic and Sport Medicine Clinic of Nova Scotia', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'L6J 3L7', 'city': 'Oakville', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Oakville Trafalgar Memorial Hospital', 'geoPoint': {'lat': 43.45011, 'lon': -79.68292}}, {'zip': 'K1S 5B6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sports Medicine Center, Carleton University', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Centre, Orthopaedics Research Office', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H4J 1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hospital Sacré-Coeur de Montréal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1J 1Z4', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHA-Pavillon Enfant-Jésus', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'J4V 2H1', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': "Hôpital Charles LeMoyne, Unité d'investigation non invasive", 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'city': 'Majadahonda', 'state': 'Madrid', 'country': 'Spain', 'facility': 'FREMAP Centro de Prevención y Rehabilitatión', 'geoPoint': {'lat': 40.47353, 'lon': -3.87182}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic i Provincial de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Gijón', 'country': 'Spain', 'facility': 'Cirugia Ortopedica y Traumatologia, Medicina del Deporte', 'geoPoint': {'lat': 43.53573, 'lon': -5.66152}}, {'zip': '28007', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital General Universitario Gregorio Marañón', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'William Stanish, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orthopaedic and Sport Medicine - Dalhousie University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not planned'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Piramal Healthcare Canada Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}