NCT05144191

Insignia™ Hip Stem Outcomes Study

Insignia™ Hip Stem Outcomes Study - A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Insignia™ Hip Stem for Total Hip Replacement Surgery

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 313 (actual)
• Sponsor: Stryker Orthopaedics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the safety and effectiveness of the Insignia™ Hip Stem for global market access and post-market clinical follow-up up to 10 years postoperative.

Detailed description

This study is a prospective, post-market, multi-center clinical investigation of the Insignia™ Hip Stem for primary and revision total hip arthroplasty (THA) in a consecutive series of patients who meet the eligibility criteria. The total enrollment goal for the study is a minimum of 313 cases, all of which will receive the Insignia™ Hip Stem.

Conditions

• Hip Osteoarthritis
• Avascular Necrosis
• Rheumatoid Arthritis
• Post-traumatic Osteoarthritis
• Femoral Neck Fractures
• Trochanteric Fractures
• Surgery

Interventions

Type	Name	Description
DEVICE	Insignia uncemented Hip Stem	Device: Replacement of arthritic hip with Insignia uncemented Hip Stem

Timeline

• Start date: 2022-02-07
• Primary completion: 2034-04-02
• Completion: 2034-04-02
• First posted: 2021-12-03
• Last updated: 2025-06-04

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated device study