Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-27 @ 7:29 AM
Study NCT ID:
NCT00793104
Status:
TERMINATED
Last Update Posted:
2013-12-25
First Post:
2008-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the CR Plug (Allograft) for the Treatment of a Cartilage Injury in the Knee.
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': 'Robin Waite , Clinical Projects Director', 'organization': 'RI Biologics'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Enrollment was closed early due for 2 factors:\n\n1\\) Slow enrollment and 2) A potential change in the regulatory pathway for allografts used in cartilage repair\n\n1 patient was lost to follow up, with no data collected at the 24-month visit.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'CR Plug', 'description': 'Placement of allograft CR Plug in primary injury site', 'otherNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Mild knee effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 16, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Moderate knee effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'reduced rom, KNEE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'whole body itching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'tingling sensation in foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'knee catching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'meniscus tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'plug protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'knee pain, mild', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'knee pain, moderate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'knee pain after activity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'increased knee pain, moderate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Graft Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Knee Injury and Osteoarthritis Outcome Score (KOOS) at 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CR Plug', 'description': 'Placement of allograft CR Plug in primary injury site'}], 'classes': [{'categories': [{'measurements': [{'value': '86.04', 'spread': '17.44', 'groupId': 'OG000'}]}]}], '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': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Current Health Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CR Plug', 'description': 'Placement of allograft CR Plug in primary injury site'}], 'classes': [{'categories': [{'measurements': [{'value': '81.1', 'spread': '22.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months, MRI only at 12 and 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': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lysholm With Tegner Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CR Plug', 'description': 'Placement of allograft CR Plug in primary injury site'}], 'classes': [{'categories': [{'measurements': [{'value': '79.6', 'spread': '22.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': "The Tegner activity scale was designed as a score of activity level to complement other functional scores (eg the Lysholm knee score) for patients with ligamentous injuries. The instrument scores a person's activity level between 0 and 100 where 0 is 'on sick leave/disability' and 100 is 'participation in competitive sports at a full, unhindered level.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'International Knee Documentation Committee (IKDC) at 24 Months.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CR Plug', 'description': 'Placement of allograft CR Plug in primary injury site'}], 'classes': [{'categories': [{'measurements': [{'value': '79.4', 'spread': '21.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': 'The International Knee Documentation Committee 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': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'MRI Evaluation Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CR Plug', 'description': 'Placement of allograft CR Plug in primary injury site'}], 'classes': [{'categories': [{'measurements': [{'value': '95.5', 'spread': '7.8', 'groupId': 'OG000'}]}]}], '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': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CR Plug', 'description': 'Placement of allograft CR Plug in primary injury site'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'All participants were recruited from the patient population at two investigative sites between 17 November 2008 and 11 June 2010.', 'preAssignmentDetails': 'There was no group assignment'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'CR Plug', 'description': 'Placement of allograft CR Plug in primary injury site'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.9', 'spread': '8.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'Slow enrolment \\& potential regulatory changes for allograft in cartilage repair', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-06', 'studyFirstSubmitDate': '2008-11-17', 'resultsFirstSubmitDate': '2013-07-12', 'studyFirstSubmitQcDate': '2008-11-18', 'lastUpdatePostDateStruct': {'date': '2013-12-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-11-06', 'studyFirstPostDateStruct': {'date': '2008-11-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Knee Injury and Osteoarthritis Outcome Score (KOOS) at 24 Months', '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', 'timeFrame': '24 months, MRI only at 12 and 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': 'Lysholm With Tegner Score', 'timeFrame': '24 months', 'description': "The Tegner activity scale was designed as a score of activity level to complement other functional scores (eg the Lysholm knee score) for patients with ligamentous injuries. The instrument scores a person's activity level between 0 and 100 where 0 is 'on sick leave/disability' and 100 is 'participation in competitive sports at a full, unhindered level."}, {'measure': 'International Knee Documentation Committee (IKDC) at 24 Months.', 'timeFrame': '24 months', 'description': 'The International Knee Documentation Committee 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.'}, {'measure': 'MRI Evaluation Score', '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['allograft', 'knee injury', 'cartilage injury', 'Osteochondral defects in the articular femoral cartilage'], 'conditions': ['Knee Injury']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.orthoindy.com', 'label': 'Click here to find more information from OrthoIndy'}]}, 'descriptionModule': {'briefSummary': 'Determine the ability of the allograft plug for the treatment of a cartilage injury in the knee', 'detailedDescription': 'The specific aim in this study is to assess the ability of the CR-Plug to treat osteochondral focal defects of less than 2.5 cm squared at high-load-bearing femoral condyle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Skeletally mature\n* Have one symptomatic score International Cartilage Repair Score (ICRS) grade 3a, 3b, 3c, 3d, 4a, 4b articular cartilage lesion less than 2.5 cm involving the Medial Femoral Condyle (MFC) or Lateral Femoral Condyle (LFC). Symptoms must include pain, pain with weight bearing and squatting, locking of joints, and/or swelling\n* Functional meniscal tissue (defined as 5 mm or more width)\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 of 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 yer prior to current study\n* Previous surgical meniscus treatments 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 with in 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'}, 'identificationModule': {'nctId': 'NCT00793104', 'briefTitle': 'Evaluation of the CR Plug (Allograft) for the Treatment of a Cartilage Injury in the Knee.', 'organization': {'class': 'INDUSTRY', 'fullName': 'RTI Surgical'}, 'officialTitle': 'Evaluation of the Composite of Cancellous and Demineralized Bone Plug (CR-Plug) for Repair of Focal Cartilage Lesions in the Femoral Condyle', 'orgStudyIdInfo': {'id': 'CRP2008'}, 'secondaryIdInfos': [{'id': 'WIRB # 20081109', 'type': 'OTHER', 'domain': 'Western IRB'}, {'id': 'St Francis IRB Project # 571', 'type': 'OTHER', 'domain': 'St. Francis IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'CR Plug', 'description': 'Placement of allograft CR Plug in primary injury site', 'interventionNames': ['Procedure: Placement of allograft CR Plug in primary injury site']}], 'interventions': [{'name': 'Placement of allograft CR Plug in primary injury site', 'type': 'PROCEDURE', 'description': 'Core defect and implant allograft CR plug', 'armGroupLabels': ['CR Plug']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90045', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Kerlan Jobe Orthopaedic Clinic', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80012', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Orthopedic Consultants', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '46237', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'OrthoIndy, Inc', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Jack Farr, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OrthoIndy, Inc'}, {'name': 'Ralph A Gambardella, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kerlan Jobe Orthopaedic Clinic'}, {'name': 'Stewart Weinerman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Colorado Orthopedic Consultants'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RTI Surgical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}