Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Erik Hansen (ucsf)
Headshot of Erik Hansen
Erik Hansen

Description

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.

Official Title

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

Details

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.

Keywords

Hip Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-traumatic Osteoarthritis, Femoral Neck Fractures, Trochanteric Fractures, Surgery, Osteoarthritis, Necrosis, Bone Fractures, Hip Fractures, Insignia uncemented Hip Stem

Eligibility

Locations

  • University of California, San Francisco
    San Francisco California 94158 United States
  • Reno Orthopedic Center Foundation
    Reno Nevada 89503 United States

Lead Scientist at University of California Health

  • Erik Hansen (ucsf)
    Dr. Erik N. Hansen is an Assistant Professor of Clinical Orthopaedic Surgery in the Arthroplasty Division at UCSF and serves as the clinical fellowship director. His clinical and revolve around primary total joint arthroplasty, including the direct anterior approach to hip replacement surgery, as well as complex revision surgery.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Stryker Orthopaedics
ID
NCT05144191
Study Type
Interventional
Participants
About 313 people participating
Last Updated