Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2026-01-20 @ 8:11 PM
Study NCT ID:
NCT02309957
Status:
COMPLETED
Last Update Posted:
2019-08-21
First Post:
2014-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EAGLE European Post Market Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-20', 'studyFirstSubmitDate': '2014-12-02', 'studyFirstSubmitQcDate': '2014-12-03', 'lastUpdatePostDateStruct': {'date': '2019-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Implant Failure', 'timeFrame': '24 months', 'description': 'Rate of implant failure resulting in device removal and/or further surgical intervention due to a device related complication'}], 'secondaryOutcomes': [{'measure': 'Knee Related Adverse Events', 'timeFrame': '24 months'}, {'measure': 'Quality of repair tissue as assessed by magnetic resonance imaging', 'timeFrame': 'at 24 months'}, {'measure': 'Improvement in knee pain and function as reported by patients on the Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Knee Cartilage Repair, Osteochondral Defects, BioMatrix CRD'], 'conditions': ['Acute Knee Cartilage Injury', 'Tear of Articular Cartilage of Knee, Current']}, 'descriptionModule': {'briefSummary': 'Prospective, multi-center, non-randomized, historical controlled, post-market study of patients requiring surgical repair of a focal articular cartilage lesion or osteochondral defect in the knee.', 'detailedDescription': 'BioMatrix CRD is a CE marked device that is intended to repair focal articular cartilage lesions or osteochondral defects in the knee. BioMatrix CRD™ is a sterile, biphasic, bioresorbable scaffold designed to aid in the repair of cartilage and subchondral bone. The device serves as a scaffold for cellular and extracellular matrix ingrowth supporting the regeneration of cartilage and subchondral bone.\n\nThe purpose of this post-market study is to confirm the safety and performance of the BioMatrix CRD for its intended use. Fifty (50) patients will be enrolled at up to 10 hospitals in Europe. Patients will be followed for 2 years post-operative to examine the rate of adverse events associated with the device, track improvement in knee pain and knee function over time, and assess the quality of repair tissue.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Observational study of patients receiving BioMatrix CRD for surgical repair of a focal articular cartilage lesion or osteochondral defect in the knee', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pre-procedure KOOS Pain subscale score less than or equal to 70.\n* ICRS grade 3 or 4 focal articular cartilage lesion on the medial femoral condyle, lateral femoral condyle or trochlea, which measures less than or equal to15mm in diameter.\n* Cartilage lesion is amenable to treatment with a single BioMatrix CRD or an osteochondral autograft.\n\nExclusion Criteria:\n\n* Previous cartilage repair procedure (i.e., microfracture, OATS, ACI) at the intended implantation site.\n* Clinically significant (\\> 5 degrees) varus or valgus malalignment in either knee.\n* Osteoarthritis in the injured knee.\n* Inflammatory arthropathy\n* Osteomyelitis or other active infection in either lower limb.\n* Cortisone or hyaluronic acid knee injections in the past 3 months\n* Body mass index greater than 35.'}, 'identificationModule': {'nctId': 'NCT02309957', 'acronym': 'EAGLE', 'briefTitle': 'EAGLE European Post Market Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kensey Nash Corporation'}, 'officialTitle': 'Evaluation of an Acellular Osteochondral Graft for Cartilage LEsions ("EAGLE") European Post Market Study', 'orgStudyIdInfo': {'id': 'EAGLE EU Post Market Study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BioMatrix CRD', 'description': 'All patients will receive BioMatrix CRD to repair an articular cartilage lesion or osteochondral defect.', 'interventionNames': ['Device: BioMatrix CRD']}], 'interventions': [{'name': 'BioMatrix CRD', 'type': 'DEVICE', 'armGroupLabels': ['BioMatrix CRD']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lübeck', 'country': 'Germany', 'facility': 'University of Schleswig-Holstein, Campus Lübeck', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'city': 'München', 'country': 'Germany', 'facility': 'Technische Universität München', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Regensburg', 'country': 'Germany', 'facility': 'Klinikum der Universität Regensburg', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'city': 'Bologna', 'country': 'Italy', 'facility': 'Istituto Ortopedico Rizzoli', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Maastricht University Medical Center (MUMC+)', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'city': 'Oswestry', 'country': 'United Kingdom', 'facility': 'Robert Jones & Agnes Hunt Orthopaedic Hospital', 'geoPoint': {'lat': 52.86195, 'lon': -3.05497}}], 'overallOfficials': [{'name': 'Justus Gille, PD Dr med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hopsital Schleswig Holstein Campus Lübeck'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kensey Nash Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}