Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-02-24 @ 4:12 AM
Study NCT ID:
NCT02452957
Status:
WITHDRAWN
Last Update Posted:
2017-10-13
First Post:
2015-05-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Effectiveness of the Tornier Simpliciti™ Shoulder System in Shoulder Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Contract issues', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-12', 'studyFirstSubmitDate': '2015-05-16', 'studyFirstSubmitQcDate': '2015-05-20', 'lastUpdatePostDateStruct': {'date': '2017-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with device related adverse events as a measure of safety', 'timeFrame': '24 months', 'description': 'All adverse events will be summarized by the number and percentage of patients with each type of event. The following will be summarized separately: procedure related adverse events, device related adverse events, anticipated adverse events. Additionally, the incidence of serious device associated adverse events will be summarized.'}], 'secondaryOutcomes': [{'measure': 'Change in the Range of Motions (ROM) as a measure of effectiveness', 'timeFrame': '24 months', 'description': 'Changes in ROM variables from the pre-implant visit to each follow-up visit will be calculated and sumarized until 24-month visit.'}, {'measure': 'Change in the Constant Score as a measure of effectiveness', 'timeFrame': '24 months', 'description': 'Changes in the Constant Score from the pre-implant visit to each follow-up visits will be calculated and summarized until 24-month visit.'}, {'measure': "Change in the DASH Score as a measure of improvement in the patients' Quality of Life", 'timeFrame': '24 months', 'description': 'Changes in the DASH Score from the pre-implant visit to each follow-up visits will be calculated and summarised until 24-month visit.'}, {'measure': 'Change in humeral cortical thickness as an evaluation of Stress Shielding', 'timeFrame': '24 months', 'description': 'Changes in humeral cortical thickness from the pre-implant to 24-month visit will be mesured according to the modified method of Tingart \\& Al.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Shoulder Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The aim of this observationnal post-marketing study is to provide additional information on the safety and effectiveness of Simpliciti™ system at 24 months post-shoulder arthroplasty , in usual surgical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult subject with clinical indication for total shoulder or hemi replacement due to primary diagnosis of osteoarthritis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A subject must meet all of the following inclusion criteria in order to enter the study:\n\n * Adult subject 18 years or older,\n * Clinical indication for total shoulder or hemi replacement due to primary diagnosis of osteoarthritis,\n * Scapula and proximal humerus must have reached skeletal maturity,\n * Willing and able to comply with the protocol,\n * Willing and able to personally sign the informed consent form,\n * Subject is legally competent, understands the nature, significance and implications of the clinical investigation, and is able to form a rational intention in the light of these facts.\n\nExclusion Criteria:\n\n* A subject will not be eligible to participate in the study if any of the following conditions is present:\n\n * lack of sufficient sound bone to seat and support the implant, including that resulting from skeletal immaturity, osteoporosis or erosive arthritis,\n * Severe Walch grade B2 glenoid defined as \\>60% posterior head displacement and \\>20% posterior glenoid bone loss,\n * metal allergies or sensitivity,\n * infection at or near the site of implantation,\n * distant or systemic infection.'}, 'identificationModule': {'nctId': 'NCT02452957', 'briefTitle': 'Safety and Effectiveness of the Tornier Simpliciti™ Shoulder System in Shoulder Arthroplasty', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stryker Trauma and Extremities'}, 'officialTitle': 'A Prospective Multi-Center Study of the Safety and Effectiveness of the Tornier Simpliciti™ Shoulder System in Shoulder Arthroplasty', 'orgStudyIdInfo': {'id': '1206-T-SIMPLICITI-RM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Device: Simpliciti™ System', 'description': 'The Simpliciti™ nucleus is a humeral prosthesis intended for total and hemi shoulder arthroplasty in patients with a severely painful and/or disabled joint resulting from osteoarthritis or traumatic arthritis.\n\nThe implant is sized to match and replicate the anatomy of the proximal humerus, while maintaining a bone conserving approach. It does not extend beyond the metaphysis, leaving the humeral canal untouched. Fixation is enhanced through a porous coating with a high coefficient of friction; resulting in a solid initial fit and long term fixation.\n\nThe Simpliciti™ nucleus is designed to receive a humeral head. The Simpliciti™ system is authorized to bear the CE mark and will be investigated within this clinical study in accordance with its intended use.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '83734', 'city': 'Hausham', 'country': 'Germany', 'facility': 'Krankenhaus Agatharied', 'geoPoint': {'lat': 47.7466, 'lon': 11.84069}}], 'overallOfficials': [{'name': 'Steve A. Erickson', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Stryker Trauma and Extremities'}, {'name': 'Ulrich Brunner, MD, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Krankenhaus Agatharied'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stryker Trauma and Extremities', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}