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Long Term Sidus PMCF

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04063943
Recruitment Status : Withdrawn (Sponsor has decided there is not a business need for this study and is not required to complete.)
First Posted : August 21, 2019
Last Update Posted : May 13, 2021
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Post-traumatic; Arthrosis Device: Sidus Stem-Free Shoulder Not Applicable

Detailed Description:

The data collected from this study will serve the purpose of assessing safety and performance of the Sidus Shoulder.

Safety: Will be assessed by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), and unanticipated adverse device effects (UADE).

Performance: Will be determined by analyzing the implant survival, overall pain and functional performances (based on the ASES Patient Questionnaire and range of motion) and radiographic parameters of subjects who received the Sidus Shoulder. Implant survival will be based on removal or intended removal and determined using the observed component years (OCY) model as it is not anticipated that there will be adequate data at the 10 years follow-up to support Kaplan-Meier survivorship analysis. In the instance that there is sufficient data to perform Kaplan-Meier analysis, the analysis will be performed.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-Term Follow-up of the Sidus® Stem-Free Shoulder Arthroplasty System
Actual Study Start Date : July 12, 2019
Actual Primary Completion Date : January 31, 2020
Actual Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Sidus Stem-Free Total Shoulder
This arm will include all subjects who are implanted with the Sidus Stem-Free Total Shoulder Arthroplasty System
 Device: Sidus Stem-Free Shoulder
Device: Sidus Stem-Free Total Shoulder Arthroplasty System


Outcome Measures
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Primary Outcome Measures :
  1. Safety: Monitoring frequency of AE, SAE and UADEs. [ Time Frame: 10 Years ]
    Will be assessed by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), and unanticipated adverse device effects (UADE).

  2. Performance: ASES Scores [ Time Frame: 10 Years ]
    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.

  3. Implant Survival [ Time Frame: 10 Years ]
    Based on removal or intended removal of the device and determined using the OCY or Kaplan-Meier method.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04063943


Locations
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United States, Kentucky
Norton Orthopaedic & Sports Medicine
Louisville, Kentucky, United States, 40241
United States, Maryland
MedStar Health
Baltimore, Maryland, United States, 21218
United States, Pennsylvania
Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
The Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
Canada, Alberta
University of Calgary Sports Medicine Clinic
Calgary, Alberta, Canada, T2N 1N4
Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
St. Joseph's Health Care London - Hand and Upper Limb Centre
London, Ontario, Canada, N6A 4L6
Sponsors and Collaborators
Zimmer Biomet
Investigators
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Study Director: Kacy Arnold, RN MBA Zimmer Biomet
More Information
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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT04063943    
Other Study ID Numbers: CSU2018-27E
First Posted: August 21, 2019    Key Record Dates
Last Update Posted: May 13, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases