Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-29 @ 11:08 PM
Study NCT ID:
NCT01820650
Status:
TERMINATED
Last Update Posted:
2023-10-25
First Post:
2013-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective, Multicenter Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 359}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Decision of investigational team', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-23', 'studyFirstSubmitDate': '2013-03-26', 'studyFirstSubmitQcDate': '2013-03-26', 'lastUpdatePostDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '2011 Knee Society Score', 'timeFrame': '1 Year'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['osteoarthritis', 'knee replacement', 'patient-specific'], 'conditions': ['Osteoarthritis of the Knee']}, 'descriptionModule': {'briefSummary': 'This study is designed to observe the long term clinical outcomes of patient-specific knee arthroplasty in patients with osteoarthritis.', 'detailedDescription': 'If the patient has previously received a standard total knee replacement in their contralateral knee, the primary endpoint questionnaire and some secondary endpoint questionnaires will be completed regarding BOTH their iTotal® CR knee and their standard total knee for all time points where questionnaires are required by the protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with osteoarthritis of the knee', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical condition included in the approved Indications For Use for the iTotal® CR\n* Osteoarthritis, as confirmed by the investigator's assessment of disease status at screening visit that warrants a TKR procedure. Disease status is assessed by Clinical and Radiographic assessment.\n* Willingness to participate in the clinical study, to give informed consent and to attend all follow-up visits\n* \\> 18 years of age\n\nExclusion Criteria:\n\n* Simultaneous bilateral procedure required\n* BMI \\> 40\n* Active malignancy (defined as a history of any invasive malignancy - except non-melanoma skin cancer), unless patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years\n* Poorly Controlled diabetes\n* Neuromuscular conditions which prevent patient from participating in study activities\n* Active local or systemic infection\n* Immunocompromised\n* Fibromyalgia or other general body pain related condition\n* Rheumatoid arthritis or other forms of inflammatory joint disease\n* Loss of bone or musculature, osteonecrosis, neuromuscular or vascular compromise in the area of the joint to be operated to an extent that the procedure is unjustified\n* Diagnosed with or receiving treatment for Osteoporosis\n* Other physical disability affecting the hips, spine, or contralateral knee.\n* Severe instability due to advanced loss of osteochondral structure\n* Prior arthroplasty of the affected knee, including High Tibial Osteotomy (HTO)\n* Compromised PCL or collateral ligament\n* Severe fixed valgus or varus deformity of \\>15º\n* Extensor lag \\> 15 º\n* Fixed flexion contracture ≥ 15 º\n* Unwilling or unable to comply with study requirements\n* Participation in another clinical study which would confound results\n* Allergy to any of the implant materials"}, 'identificationModule': {'nctId': 'NCT01820650', 'briefTitle': 'A Prospective, Multicenter Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Restor3D'}, 'officialTitle': 'A Prospective, Multicenter Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System', 'orgStudyIdInfo': {'id': '12-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'iTotal G2 CR Knee Replacement System', 'type': 'DEVICE', 'description': 'Total Knee replacement'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33462', 'city': 'Atlantis', 'state': 'Florida', 'country': 'United States', 'facility': 'JFK Medical Center', 'geoPoint': {'lat': 26.5909, 'lon': -80.10088}}, {'zip': '04401', 'city': 'Bangor', 'state': 'Maine', 'country': 'United States', 'facility': 'EMMC - Orthopaedic Surgery of Maine', 'geoPoint': {'lat': 44.79884, 'lon': -68.77265}}, {'zip': '49015', 'city': 'Battle Creek', 'state': 'Michigan', 'country': 'United States', 'facility': 'Great Lakes Bone and Joint', 'geoPoint': {'lat': 42.3173, 'lon': -85.17816}}, {'zip': '89052', 'city': 'Henderson', 'state': 'Nevada', 'country': 'United States', 'facility': 'Orthopaedic Instatute of Henderson', 'geoPoint': {'lat': 36.0397, 'lon': -114.98194}}, {'zip': '89121', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Desert Orthopedic Center', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Orthopaedic Alliance', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77429', 'city': 'Cypress', 'state': 'Texas', 'country': 'United States', 'facility': 'Advanced Orthopedics and Sports Medicine', 'geoPoint': {'lat': 29.96911, 'lon': -95.69717}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Joint Replacement Associates', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '05661', 'city': 'Morrisville', 'state': 'Vermont', 'country': 'United States', 'facility': 'Mansfield Orthopaedics', 'geoPoint': {'lat': 44.56172, 'lon': -72.59845}}], 'overallOfficials': [{'name': 'Marc Quartulli', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Restor3D'}, {'name': 'Terry Clyburn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Restor3D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}