Active — Not RecruitingNot Applicable

Insignia™ Hip Stem Outcomes Study

United States313 participantsStarted 2022-02-07

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 pertainin…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this study is no longer recruiting new participants, is there another ongoing trial or registry studying the Insignia hip stem that I could potentially be considered for?
2This study is tracking the Insignia hip stem's survival rate and Harris Hip Score over time — how does the device being studied here compare to the hip replacement implant you would recommend for my specific condition, whether that's osteoarthritis, avascular necrosis, or a fracture?
3Because this is a Phase 'NA' outcomes study rather than a traditional clinical trial testing a new treatment, what does that mean for how much is already known about the safety and real-world performance of the Insignia hip stem before I consider it?
4The Harris Hip Score is one of the main things being measured here — can you explain what a meaningful improvement in that score would look like for my daily life, and how patients with my diagnosis have typically scored after this type of hip replacement?
5Given that this study covers several different conditions including fractures, arthritis, and avascular necrosis, would standard hip replacement with this implant or a different approach be a better first option for my particular situation before looking at any study involvement?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Survival Rate

Timeframe: 10 years

Harris Hip Score (HHS)

Timeframe: 10 Years

Trial details

NCT IDNCT05144191

SponsorStryker Orthopaedics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2034-04-02

View on ClinicalTrials.gov More Hip Osteoarthritis trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.