Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-02-21 @ 4:09 AM
Study NCT ID:
NCT04301258
Status:
TERMINATED
Last Update Posted:
2025-11-21
First Post:
2020-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ProChondrix® CR Articular Cartilage Restoration Evaluation (PACE) Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Duplicative data/insufficient enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2020-03-06', 'studyFirstSubmitQcDate': '2020-03-06', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Long-Term Outcomes of ProChondrix CR', 'timeFrame': '10 Years Post-Operative', 'description': 'Obtain long-term results on patients who have undergone an articular cartilage repair procedure using ProChondrix CR, as assessed by patient reported outcomes.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cartilage', 'Cartilage Injury', 'Cartilage Repair', 'Cartilage Damage', 'Cartilage Lesion', 'Cartilage Defect'], 'conditions': ['Cartilage Injury', 'Cartilage Damage']}, 'descriptionModule': {'briefSummary': 'The primary objective of this registry is to obtain long-term outcomes on ProChondrix CR in cartilage repair procedures of the knee, ankle, foot and hip.', 'detailedDescription': 'This multi-center, observational registry will be used to evaluate the effectiveness of ProChondrix CR in patients who undergo treatment for an articular cartilage defect in the knee, ankle, foot or hip.\n\nThis registry will be performed at up to 30 clinical sites across the United States.\n\nPatient follow-up will occur following an articular cartilage repair procedure in which the patient receives ProChondrix CR. During this follow-up period, each patient will be evaluated at least four (4) times at: 3, 6, 12 and 24 months after surgical intervention and will continue annually for as long as patients are willing to fill out questionnaires and outcomes assessments up to 10 years post operatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients, who diagnosed by their treating physician, have a cartilage defect in the knee, ankle, foot or hip that requires surgical intervention utilizing ProChondrix CR.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed by physician to have a cartilage defect in the knee, ankle, foot or hip that requires surgical intervention;\n* Will be having, or has had, a cartilage repair procedure using ProChondrix CR;\n* Has the ability to understand the requirements of the registry, to provide written informed consent and to comply with the registry protocol;\n\nExclusion Criteria:\n\n• Is a ward of the state, prisoner, or transient.'}, 'identificationModule': {'nctId': 'NCT04301258', 'briefTitle': 'ProChondrix® CR Articular Cartilage Restoration Evaluation (PACE) Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'AlloSource'}, 'officialTitle': 'ProChondrix® CR Articular Cartilage Restoration Evaluation (PACE) Registry', 'orgStudyIdInfo': {'id': 'REG-PRO-002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Articular Cartilage Defect of the Knee', 'description': 'Patients, who undergo an articular cartilage repair of the knee using ProChondrix CR.', 'interventionNames': ['Other: Articular cartilage repair']}, {'label': 'Articular Cartilage Defect of the Ankle', 'description': 'Patients, who undergo an articular cartilage repair of the ankle using ProChondrix CR.', 'interventionNames': ['Other: Articular cartilage repair']}, {'label': 'Articular Cartilage Defect of the Foot', 'description': 'Patients, who undergo an articular cartilage repair of the foot using ProChondrix CR.', 'interventionNames': ['Other: Articular cartilage repair']}, {'label': 'Articular Cartilage Defect of the Hip', 'description': 'Patients, who undergo an articular cartilage repair of the hip using ProChondrix CR.', 'interventionNames': ['Other: Articular cartilage repair']}], 'interventions': [{'name': 'Articular cartilage repair', 'type': 'OTHER', 'otherNames': ['ProChondrix CR'], 'description': 'Patient reported outcomes will be collected on patients who have had a cartilage repair procedure using ProChondrix CR in the knee, hip, foot or ankle.', 'armGroupLabels': ['Articular Cartilage Defect of the Ankle', 'Articular Cartilage Defect of the Foot', 'Articular Cartilage Defect of the Hip', 'Articular Cartilage Defect of the Knee']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36604', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Southern Alabama', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '80033', 'city': 'Wheat Ridge', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Foot and Ankle Center', 'geoPoint': {'lat': 39.7661, 'lon': -105.07721}}, {'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'CAO Research Foundation', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '40506', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky Research Foundation', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '45247', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Beacon Orthopaedics & Sports Medicine', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AlloSource', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}