Long Term Sidus PMCF

Long-Term Follow-up of the Sidus® Stem-Free Shoulder Arthroplasty System

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.

Study Overview

• Status: Withdrawn
• Conditions: Osteoarthritis; Post-traumatic; Arthrosis
• Intervention / Treatment: Device: Sidus Stem-Free Shoulder

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: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 1N4
      • University of Calgary Sports Medicine Clinic
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
      • Kingston General Hospital
    • London, Ontario, Canada, N6A 4L6
      • St. Joseph's Health Care London - Hand and Upper Limb Centre
• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Norton Orthopaedic & Sports Medicine
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • MedStar Health
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Rothman Institute
    • Philadelphia, Pennsylvania, United States, 19107
      • The Rothman Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Implant Survival	Based on removal or intended removal of the device and determined using the OCY or Kaplan-Meier method.	10 Years

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Kacy Arnold, RN MBA, Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2019
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): March 31, 2020

Study Registration Dates

• First Submitted: July 2, 2019
• First Submitted That Met QC Criteria: August 20, 2019
• First Posted (Actual): August 21, 2019

Study Record Updates

• Last Update Posted (Actual): May 13, 2021
• Last Update Submitted That Met QC Criteria: May 10, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: CSU2018-27E

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes