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Long Term Sidus PMCF

Primary Purpose

Osteoarthritis, Post-traumatic; Arthrosis

Status
Withdrawn
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Sidus Stem-Free Shoulder
Sponsored by
Zimmer Biomet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Norton Orthopaedic & Sports Medicine
  • MedStar Health
  • Rothman Institute
  • The Rothman Institute
  • University of Calgary Sports Medicine Clinic
  • Kingston General Hospital
  • St. Joseph's Health Care London - Hand and Upper Limb Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sidus Stem-Free Total Shoulder

Arm Description

This arm will include all subjects who are implanted with the Sidus Stem-Free Total Shoulder Arthroplasty System

Outcomes

Primary Outcome Measures

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).
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.
Implant Survival
Based on removal or intended removal of the device and determined using the OCY or Kaplan-Meier method.

Secondary Outcome Measures

Full Information

First Posted
July 2, 2019
Last Updated
May 10, 2021
Sponsor
Zimmer Biomet
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1. Study Identification

Unique Protocol Identification Number
NCT04063943
Brief Title
Long Term Sidus PMCF
Official Title
Long-Term Follow-up of the Sidus® Stem-Free Shoulder Arthroplasty System
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor has decided there is not a business need for this study and is not required to complete.
Study Start Date
July 12, 2019 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Post-traumatic; Arthrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sidus Stem-Free Total Shoulder
Arm Type
Experimental
Arm Description
This arm will include all subjects who are implanted with the Sidus Stem-Free Total Shoulder Arthroplasty System
Intervention Type
Device
Intervention Name(s)
Sidus Stem-Free Shoulder
Intervention Description
Device: Sidus Stem-Free Total Shoulder Arthroplasty System
Primary Outcome Measure Information:
Title
Safety: Monitoring frequency of AE, SAE and UADEs.
Description
Will be assessed by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), and unanticipated adverse device effects (UADE).
Time Frame
10 Years
Title
Performance: ASES Scores
Description
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.
Time Frame
10 Years
Title
Implant Survival
Description
Based on removal or intended removal of the device and determined using the OCY or Kaplan-Meier method.
Time Frame
10 Years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kacy Arnold, RN MBA
Organizational Affiliation
Zimmer Biomet
Official's Role
Study Director
Facility Information:
Facility Name
Norton Orthopaedic & Sports Medicine
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
MedStar Health
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
Rothman Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
The Rothman Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University of Calgary Sports Medicine Clinic
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 1N4
Country
Canada
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
St. Joseph's Health Care London - Hand and Upper Limb Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada

12. IPD Sharing Statement

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Long Term Sidus PMCF

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