Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-31 @ 3:27 PM
Study NCT ID:
NCT01587560
Status:
UNKNOWN
Last Update Posted:
2016-08-30
First Post:
2012-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison Between a Pyrocarbon and a CoCr Shoulder Resurfacing Implant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-29', 'studyFirstSubmitDate': '2012-02-17', 'studyFirstSubmitQcDate': '2012-04-27', 'lastUpdatePostDateStruct': {'date': '2016-08-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fixation to bone as measured with radiostereometric analysis (RSA)', 'timeFrame': '24 months', 'description': 'Early migration of the implants will be measured with RSA at 3, 6, 12 and 24 months.'}], 'secondaryOutcomes': [{'measure': 'Clinical results after surgery as measured with EuroQol-5D(EQ-5D), American Shoulder and Elbow Surgeons Score(ASES), Constant score, and Western Ontario Osteoarthritis of the Shoulder index(WOOS)', 'timeFrame': '24-48 months', 'description': 'Outcome after surgery will be evaluated using the above mentioned scores performed by and independent and blinded investigator.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Shoulder', 'Arthroplasty', 'Pyrocarbon', 'Randomized controlled trial', 'Shoulder resurfacing'], 'conditions': ['Osteoarthritis of the Shoulder']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to investigate fixation to bone and the clinical results following shoulder resurfacing arthroplasty. The study will compare results between an implant made of Cobalt-Chrome(CoCr) and an implant made in pyrocarbon.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary or secondary osteoarthritis of the shoulder\n* Age 40-75 years\n* Patient capable of giving informed consent\n* Patient agrees to comply with the study plan\n\nExclusion Criteria:\n\n* Destruction of the proximal humerus\n* Insufficient bone stock\n* Deficient rotator cuff or earlier failed surgery of the rotator cuff\n* Large muscle defects or insufficient blood supply in the affected arm\n* Neuromuscular disorders\n* Infection, untreated malignancy or transmittable disease preventing the patient from fulfilling the study\n* Patient unwilling to comply with study regulations\n* Patient with earlier allergic reaction to pyrocarbon\n* Patient with known metastatic disease\n* Patient who has been treated with more than 10 mg corticosteroids (e.g. Prednisone) daily within 3 months from surgery.\n* Patient participating in other clinical study\n* Patient in need of glenoid replacement'}, 'identificationModule': {'nctId': 'NCT01587560', 'briefTitle': 'A Comparison Between a Pyrocarbon and a CoCr Shoulder Resurfacing Implant', 'organization': {'class': 'OTHER', 'fullName': 'Danderyd Hospital'}, 'orgStudyIdInfo': {'id': 'PyroTITAN DS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pyrocarbon', 'description': 'Patients receiving a shoulder surface replacement implant made of pyrocarbon (the PyroTITAN Humeral resurfacing Arthroplasty)', 'interventionNames': ['Device: PyroTITAN, Ascension Orthopedics, Inc.', 'Device: TITAN, Ascension Orthopedics, Inc.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CoCr', 'description': 'Patients receiving a shoulder surface replacement implant made of Cobalt-Chrome(CoCR) (the TITAN Humeral Resurfacing Arthroplasty)', 'interventionNames': ['Device: PyroTITAN, Ascension Orthopedics, Inc.', 'Device: TITAN, Ascension Orthopedics, Inc.']}], 'interventions': [{'name': 'PyroTITAN, Ascension Orthopedics, Inc.', 'type': 'DEVICE', 'otherNames': ['TITAN, Ascension Orthopedics, Inc.'], 'description': 'All patients will be operated on with a shoulder resurfacing implant. In one arm of the study, the patients will receive an implant made of pyrocarbon. In the second arm, the patients will receive an implant made of Cobalt-Chrome. Aside from the materials, the implant are of the same design.', 'armGroupLabels': ['CoCr', 'Pyrocarbon']}, {'name': 'TITAN, Ascension Orthopedics, Inc.', 'type': 'DEVICE', 'armGroupLabels': ['CoCr', 'Pyrocarbon']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18288', 'city': 'Stockholm', 'state': 'Stockholm County', 'country': 'Sweden', 'facility': 'Orthopaedic department, Danderyd Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danderyd Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ascension Orthopedics, Inc.', 'class': 'INDUSTRY'}, {'name': 'Swedish Shoulder and Elbow Arthroplasty Register', 'class': 'UNKNOWN'}, {'name': 'Karolinska Institutet', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of research, Orthopedic dept.', 'investigatorFullName': 'Olof Skoldenberg', 'investigatorAffiliation': 'Danderyd Hospital'}}}}