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Clinical Trials in the USA / NCT05144191
Active, not recruiting Not applicable

Insignia™ Hip Stem Outcomes Study

NCT05144191 · tracked via the Priya Life Science USA tracker
Sponsor
Stryker Orthopaedics
Phase
Not applicable
Started
2022-02-07
Last updated
2026-05-18

Condition(s) studied

Hip OsteoarthritisAvascular NecrosisRheumatoid ArthritisPost-traumatic OsteoarthritisFemoral Neck FracturesTrochanteric FracturesSurgery

Investigational drug(s) / intervention(s)

Insignia uncemented Hip Stem

Insignia uncemented Hip Stem: Device: Replacement of arthritic hip with Insignia uncemented Hip Stem

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (11)

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

More Stryker Orthopaedics trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05144191 on ClinicalTrials.gov ↗ ← All trials in the USA