Osteoarthritis Clinical Trial
Official title:
Long-Term Follow-up of the Sidus® Stem-Free Shoulder Arthroplasty System
Verified date | May 2021 |
Source | Zimmer Biomet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objectives of this study are to assess the safety and performance of the Sidus Stem-Free Shoulder Arthroplasty System in unilateral primary total shoulder arthroplasty.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 31, 2020 |
Est. primary completion date | January 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Patient must have previously participated in the Sidus IDE clinical trial. - Patient must not have undergone revision of the Sidus shoulder. - Patient must be able and willing to complete the protocol required follow-up. - Patient must be able and willing to sign the IRB/EC approved informed consent. Exclusion Criteria: - Patient is a prisoner. - Patient is a current alcohol or drug abuser. - Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions. - Patient did not previously participate in the Sidus IDE clinical trial. - Patient no longer has Sidus shoulder implanted. |
Country | Name | City | State |
---|---|---|---|
Canada | University of Calgary Sports Medicine Clinic | Calgary | Alberta |
Canada | Kingston General Hospital | Kingston | Ontario |
Canada | St. Joseph's Health Care London - Hand and Upper Limb Centre | London | Ontario |
United States | MedStar Health | Baltimore | Maryland |
United States | Norton Orthopaedic & Sports Medicine | Louisville | Kentucky |
United States | Rothman Institute | Philadelphia | Pennsylvania |
United States | The Rothman Institute | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Zimmer Biomet |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety: Monitoring frequency of AE, SAE and UADEs. | Will be assessed by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), and unanticipated adverse device effects (UADE). | 10 Years | |
Primary | Performance: ASES Scores | Will be determined by analyzing the ASES Questionnaire in subjects who received the Sidus Shoulder. ASES consists of 3 subcomponent scores including pain, instability and activities of daily living. The pain score can be 0 to 10 with 0 being no pain and 10 being the worst pain imaginable. The instability score can be 0 to 10 with 0 being no instability and 10 being the worst instability imaginable. The activities of daily living consists of 10 questions with ordinal responses of 0, 1, 2, and 3. 3 involves no limitation and 0 is unable to do. The 3 subcomponents combine to make the overall ASES score which can range from 0 to 100 with 0 being the worst possible score and 100 being the best. | 10 Years | |
Primary | Implant Survival | Based on removal or intended removal of the device and determined using the OCY or Kaplan-Meier method. | 10 Years |
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