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)
Survival Rate — 10 years Evaluation of the survival rate for Insignia Hip Stem is defined as absence of femoral stem revision for aseptic loosening or device-related femoral fracture.
Harris Hip Score (HHS) — 10 Years The Harris Hip Score (HHS) assesses pain, function, joint deformity and range of motion.
Scores can range from 0 to 100 with 0 being the worst and 100 being the best score.
A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor
Trial sites (11)
Facility
City
Region
Status
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
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.
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