Insignia™ Hip Stem Outcomes Study

Running, not enrolling · Not applicable

Conditions studied: Hip Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-traumatic Osteoarthritis, Femoral Neck Fractures, Trochanteric Fractures, Surgery

In brief

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.

Key facts

Study ID

NCT05144191

Run by

Stryker Orthopaedics

People needed

313

Starts

2022-02-07

Expected to finish

2034-04-02

Last updated by the study team

2026-05-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subject has signed an Institutional Review Board (IRB)-approved, study specific Informed Consent Form (ICF).
• The subject is skeletally mature
• The subject has a diagnosis as listed in the instructions for use (IFU), which include non inflammatory degenerative joint disease (including osteoarthritis or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis, correction of functional deformity, treatment of nonunion, femoral neck and trochanteric fractures.
• The subject is a candidate for a primary or revision cementless THA.
• The subject is willing and able to comply with postoperative scheduled clinical evaluations.

You may not qualify if…

• The subject is pregnant or breastfeeding
• The subject has an active or suspected latent infection in or about the affected hip joint at the time of study device implantation.
• The subject has any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
• The subject has bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
• The subject is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
• The subject has a known sensitivity to device materials.
• The subject is involved in any ongoing legal matter, investigation, or dispute pertaining to the operative site.
• The subject is a prisoner.

Where it is running

• The MORE Foundation — Phoenix, Arizona, United States
• University of California, San Francisco — San Francisco, California, United States
• Midwest Orthopaedics at Rush — Chicago, Illinois, United States
• Reno Orthopedic Center Foundation — Reno, Nevada, United States
• Northwell Health: University Orthopaedic Associates — Great Neck, New York, United States
• OrthoCarolina Research Institute — Charlotte, North Carolina, United States
• Alleghany Health Network- Research Institute — Pittsburgh, Pennsylvania, United States
• TOA Research Foundation — Nashville, Tennessee, United States
• Baylor Scott and White Medical Center — Temple, Texas, United States
• Orthopedic Physician Associates — Seattle, Washington, United States
• Providence Orthopedics and Sports Medicine — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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