NCT01878253

Sidus Stem-Free Shoulder IDE Study

Multicenter Trial of the Sidus Stem-Free Shoulder Arthroplasty System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if Sidus stem-free shoulder system is safe and effective when used in total shoulder replacement.

Detailed description

The primary objectives of this study are to evaluate the safety and efficacy (defined as follows) of the Sidus Stem-Free Shoulder System in unilateral primary total shoulder arthroplasty. Safety: Will be evaluated by monitoring the frequency and incidence of device related adverse events or unanticipated adverse device effects (UADEs) in investigational subjects as well as analyzing survivorship using revision or intended revision as an endpoint. Efficacy: Will be determined by comparing the overall pain and functional performance, survivorship and radiographic success of investigational subjects with those subjects who received the control devices.

Conditions

• Osteoarthritis
• Posttraumatic Arthrosis
• Rheumatoid Arthritis

Interventions

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

Timeline

• Start date: 2013-07-01
• Primary completion: 2018-05-01
• Completion: 2019-01-01
• First posted: 2013-06-14
• Last updated: 2019-07-15
• Results posted: 2019-07-15

Locations

11 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study