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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04063943
Other study ID # CSU2018-27E
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date July 12, 2019
Est. completion date March 31, 2020

Study information

Verified date May 2021
Source Zimmer Biomet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Sidus Stem-Free Shoulder
Device: Sidus Stem-Free Total Shoulder Arthroplasty System

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

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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