Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-02-24 @ 5:45 AM
Study NCT ID:
NCT00984594
Status:
TERMINATED
Last Update Posted:
2014-06-04
First Post:
2009-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of a Composite Cancellous and Demineralized Bone Plug (CR-Plug) for Repair of Knee Osteochondral Defects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007718', 'term': 'Knee Injuries'}], 'ancestors': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rwaite@rtix.com', 'phone': '386-418-8888', 'title': 'Director, Clinical Projects', 'phoneExt': '4172', 'organization': 'RTI Biologics'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Enrollment was closed early due to slow enrollment \\& a potential change in the regulatory pathway for the allograft used in cartilage repair.'}}, 'adverseEventsModule': {'timeFrame': 'Patients were followed through the termination of the study, i.e. 24 months', 'eventGroups': [{'id': 'EG000', 'title': 'Backfill', 'description': 'CR-Plug will be placed in harvest site.', 'otherNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Primary', 'description': 'Autograft will be placed in primary defect site.', 'otherNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Increased pain in right knee', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased swelling in right knee', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Motor Vehicle Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Open Reduction Internal Fixation of talus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Knee Injury and Osteoarthritis Outcome Score (KOOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Backfill', 'description': 'Autograft will be placed in the primary defect site; CR Plug will be placed in the harvest site'}, {'id': 'OG001', 'title': 'Primary', 'description': 'CR Plug will be placed in the site of the primary injury'}], 'classes': [{'categories': [{'measurements': [{'value': '82.74', 'groupId': 'OG000', 'lowerLimit': '82.74', 'upperLimit': '82.74'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': 'The outcome at 24 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 2 patients enrolled in the backfill group, 1 was lost to follow-up, therefore the data presented is for only 1 patient.'}, {'type': 'SECONDARY', 'title': 'Current Health Assessment (CHA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Backfill', 'description': 'Autograft will be placed in the primary defect site, CR Plug will be placed in the harvest site.'}, {'id': 'OG001', 'title': 'Primary', 'description': 'CR Plug will be placed in the site of the primary injury.'}], 'classes': [{'categories': [{'measurements': [{'value': '80.6', 'groupId': 'OG000', 'lowerLimit': '80.6', 'upperLimit': '80.6'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': 'Evaluation on the Current Health Assessment at 24 months. Scores are transformed to a 0-100 scale, with zero representing a self-graded perception of extremely poor health and 100 representing no health problems. Scores between 0 and 100 represent the percentage of total possible score achieved.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 2 patients enrolled in the study in the backfill group, 1 was lost to follow-up, therefore the data presented is for only 1 patient.'}, {'type': 'SECONDARY', 'title': 'IKDC Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Backfill', 'description': 'Autograft will be placed in the primary defect site, CR Plug will be placed in the harvest site.'}, {'id': 'OG001', 'title': 'Primary', 'description': 'CR Plug will be placed in the site of the primary injury.'}], 'classes': [{'categories': [{'measurements': [{'value': '74.7', 'groupId': 'OG000', 'lowerLimit': '74.7', 'upperLimit': '74.7'}, {'value': '98.6', 'groupId': 'OG001', 'lowerLimit': '98.6', 'upperLimit': '98.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': 'The International Knee Documentation Committee (IKDC) scores from 24 months are shown. The IKDC is an index score from 0 to 100, with 100 being the best possible score,', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 2 patients enrolled in the study in the backfill group, 1 was lost to follow-up, therefore the data presented is for only 1 patient.'}, {'type': 'SECONDARY', 'title': 'Magnetic Resonance Imaging (MRI) Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Backfill', 'description': 'Autograft will be placed in the primary defect site, CR Plug will be placed in the harvest site.'}, {'id': 'OG001', 'title': 'Primary', 'description': 'CR Plug will be placed in the site of the primary injury.'}], 'classes': [{'categories': [{'measurements': [{'value': '97.1', 'groupId': 'OG000', 'lowerLimit': '97.1', 'upperLimit': '97.1'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': 'MRI images were graded by a radiologist with regard to the incorporation of the CR graft in both the cancellous and cortical portions of the bone at the graft site. The raw scores were converted to an index scale form 0 to 100, with 0 representing failure of the graft to incorporate and 100 representing complete incorporation of the graft.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 2 patients enrolled in the study in the backfill group, 1 was lost to follow-up, therefore the data presented is for only 1 patient.'}, {'type': 'SECONDARY', 'title': 'Lysholm Score at 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Backfill', 'description': 'Autograft will be placed in the primary defect site, CR Plug will be placed in the harvest site.'}, {'id': 'OG001', 'title': 'Primary', 'description': 'CR Plug will be placed in the site of the primary injury.'}], 'classes': [{'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000', 'lowerLimit': '81', 'upperLimit': '81'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': 'The Lysholm scores from the 24-month exams are shown. The Lysholm score is an indexed score of knee functional ability, with 0 being the worst score and 100 being the best score, indicating no limitations in activity/function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 2 patients enrolled in the study in the backfill group, 1 was lost to follow-up, therefore the data presented is for only 1 patient.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Backfill', 'description': 'Autograft will be placed in the primary defect site, CR Plug will be placed in the harvest site.'}, {'id': 'FG001', 'title': 'Primary', 'description': 'CR Plug will be placed in the site of the primary injury.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'comment': 'One patient withdrew consent and left the study before treatment.', 'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'All participants were recruited from the patient population at one of the investigative sites between 12 June 2009 and 5 May 2010.\n\nOne subject was enrolled at 17 years, 7 months. A protocol waiver was approved by the Institutional Review Board and parental informed consent and assent of subject was obtained.', 'preAssignmentDetails': 'Patients were assigned to the treatment arm based on a randomization table. Enrolled patients excluded: Not fulfilling inclusion or exclusion criteria, withdrawal of consent. Enrolled patients were followed to completion unless lost to follow up. Of 4 enrolled, 1 withdrew consent, 1 was lost to follow up \\& 2 completed'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Backfill', 'description': 'Autograft will be placed in the primary defect site; CR Plug will be placed in the harvest site'}, {'id': 'BG001', 'title': 'Primary', 'description': 'CR Plug will be placed in the site of the primary injury'}, {'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': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.5', 'spread': '12.02', 'groupId': 'BG000'}, {'value': '17', 'spread': '0', 'groupId': 'BG001'}, {'value': '24.7', 'spread': '10.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'There are only 3 patients in the baseline analysis due to one patient withdrawing from the study before data collection.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'Slow enrolment \\& potential regulatory changes for allograft in cartilage repair', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-22', 'studyFirstSubmitDate': '2009-09-24', 'resultsFirstSubmitDate': '2013-07-10', 'studyFirstSubmitQcDate': '2009-09-24', 'lastUpdatePostDateStruct': {'date': '2014-06-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-22', 'studyFirstPostDateStruct': {'date': '2009-09-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knee Injury and Osteoarthritis Outcome Score (KOOS', 'timeFrame': '24 months', 'description': 'The outcome at 24 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.'}], 'secondaryOutcomes': [{'measure': 'Current Health Assessment (CHA)', 'timeFrame': '24 months', 'description': 'Evaluation on the Current Health Assessment at 24 months. Scores are transformed to a 0-100 scale, with zero representing a self-graded perception of extremely poor health and 100 representing no health problems. Scores between 0 and 100 represent the percentage of total possible score achieved.'}, {'measure': 'IKDC Assessment', 'timeFrame': '24 months', 'description': 'The International Knee Documentation Committee (IKDC) scores from 24 months are shown. The IKDC is an index score from 0 to 100, with 100 being the best possible score,'}, {'measure': 'Magnetic Resonance Imaging (MRI) Results', 'timeFrame': '24 months', 'description': 'MRI images were graded by a radiologist with regard to the incorporation of the CR graft in both the cancellous and cortical portions of the bone at the graft site. The raw scores were converted to an index scale form 0 to 100, with 0 representing failure of the graft to incorporate and 100 representing complete incorporation of the graft.'}, {'measure': 'Lysholm Score at 24 Months', 'timeFrame': '24 months', 'description': 'The Lysholm scores from the 24-month exams are shown. The Lysholm score is an indexed score of knee functional ability, with 0 being the worst score and 100 being the best score, indicating no limitations in activity/function.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['allograft', 'knee injury', 'cartilage injury'], 'conditions': ['Knee Injury']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine how effective a plug made out of human bone (called "CR-Plug") will be in the treatment of smaller, focal defects (like the injury the patient has to their knee).', 'detailedDescription': 'The main objective of this double arm study is to test the ability of an allograft plug to provide "successful" repair of less than (\\<) 2.5 cm2 osteochondral defect in a low-load-bearing femoral condyle region, and a high-load-bearing femoral-condyle region.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 55 years\n* skeletally mature\n* Have a symptomatic score International Cartilage Repair Society (ICRS) grade 3a, 3b, 3c, 3d, 4a, 4b articular cartilage lesion less than 2.5 cm involving the Medial Femoral Condyle or Lateral Femoral Condyle. Symptoms must include pain, pain with weight bearing and squatting, locking of joints and or swelling\n* Functional meniscal tissue (defined as 5 mmor greater)\n* A score of = or greater than 4 on the VAS questionnaire\n\nExclusion Criteria:\n\n* Associated tibial or patellar articular cartilage defect greater than 2 ICRS\n* Osteoarthritis of either knee\n* Mechanical axis malalignment of greater than 5 degrees\n* Patellofemoral incongruity on Merchant view\n* One or more multiple defects greater than 2.5 cm\n* Osteochondritis dissecans (OCD) with depth of bone loss greater than 4 mm\n* Ligament treatments in the affected knee within one year prior to current study\n* Previous surgical meniscus treatment in the affected knee in the last 6 months\n* Less than 5 mm of meniscal tissue in ipsilateral compartment of study treatment\n* use of any investigational therapy within 30 days prior to the first visit\n* Corticosteroid or viscosupplementation within the past 3 months\n* A score of 3 or less on the VAS questionnaire\n* Active gout or pseudogout or systemic inflammatory condition\n* Microfracture less than one year prior to current study'}, 'identificationModule': {'nctId': 'NCT00984594', 'briefTitle': 'Evaluation of a Composite Cancellous and Demineralized Bone Plug (CR-Plug) for Repair of Knee Osteochondral Defects', 'organization': {'class': 'INDUSTRY', 'fullName': 'RTI Surgical'}, 'officialTitle': 'Evaluation of the Composite of Cancellous and Demineralized Bone Plug (CR-Plug) for Repair of Osteochondral Defects in High-Load-Bearing Region and Low-Load-Bearing Region of the Femoral Condyle', 'orgStudyIdInfo': {'id': 'CR2008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Primary injury site', 'description': 'CR-Plug will be placed in the site of the primary injury', 'interventionNames': ['Other: Primary injury site']}, {'type': 'OTHER', 'label': 'Backfill site', 'description': 'Autograft will be placed in the site of the primary injury; CR Plug will be placed in the harvest site', 'interventionNames': ['Other: Backfill site']}], 'interventions': [{'name': 'Primary injury site', 'type': 'OTHER', 'description': 'Autograft will be placed in the primary defect site.', 'armGroupLabels': ['Primary injury site']}, {'name': 'Backfill site', 'type': 'OTHER', 'description': 'Autograft will be placed in the primary defect site; CR-Plug will be placed in the harvest site.', 'armGroupLabels': ['Backfill site']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Ellis and Badenhausen Orthopaedics, PSC', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}], 'overallOfficials': [{'name': 'Akbar Nawab, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ellis and Badenhausen Orthopaedics, PSC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RTI Surgical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}