NCT04063943

Long Term Sidus PMCF

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis
• Post-traumatic; Arthrosis

Interventions

Type	Name	Description
DEVICE	Sidus Stem-Free Shoulder	Device: Sidus Stem-Free Total Shoulder Arthroplasty System

Timeline

• Start date: 2019-07-12
• Primary completion: 2020-01-31
• Completion: 2020-03-31
• First posted: 2019-08-21
• Last updated: 2021-05-13

Locations

7 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study