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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Recruitment Status : Withdrawn (Sponsor has decided there is not a business need for this study and is not required to complete.)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

Tracking Information
First Submitted Date  ICMJE July 2, 2019
First Posted Date  ICMJE August 21, 2019
Last Update Posted Date May 13, 2021
Actual Study Start Date  ICMJE July 12, 2019
Actual Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2019)
  • 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).
  • 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.
  • Implant Survival [ Time Frame: 10 Years ]
    Based on removal or intended removal of the device and determined using the OCY or Kaplan-Meier method.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long Term Sidus PMCF
Official Title  ICMJE Long-Term Follow-up of the Sidus® Stem-Free Shoulder Arthroplasty System
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoarthritis
  • Post-traumatic; Arthrosis
Intervention  ICMJE Device: Sidus Stem-Free Shoulder
Device: Sidus Stem-Free Total Shoulder Arthroplasty System
Study Arms  ICMJE Experimental: Sidus Stem-Free Total Shoulder
This arm will include all subjects who are implanted with the Sidus Stem-Free Total Shoulder Arthroplasty System
Intervention: Device: Sidus Stem-Free Shoulder
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 10, 2021)
0
Original Estimated Enrollment  ICMJE
 (submitted: August 20, 2019)
95
Actual Study Completion Date  ICMJE March 31, 2020
Actual Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04063943
Other Study ID Numbers  ICMJE CSU2018-27E
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Zimmer Biomet
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Zimmer Biomet
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Kacy Arnold, RN MBA Zimmer Biomet
PRS Account Zimmer Biomet
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP