Long Term Sidus PMCF

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04063943
• Other study ID #: CSU2018-27E
• Status: Withdrawn
• Phase: N/A
• 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
• 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• Status: Withdrawn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.

Related Conditions & MeSH terms

• Joint Diseases
• Osteoarthritis
• Post-traumatic; Arthrosis

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