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New hip stem implant tracked for 10 years in 313 patients

NCT ID NCT05144191

Disease control Sponsor: Stryker Orthopaedics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how well the Insignia Hip Stem works and how safe it is for people needing a total hip replacement. It includes 313 adults with conditions like hip arthritis or fractures. Researchers will check implant survival and hip function for up to 10 years after surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

313 people

The number who actually took part.

Started

Feb 2022

Expected to finish

Apr 2034

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

avascular necrosis femoral neck fracture hip fracture osteoarthritis osteoarthritis, hip osteonecrosis rheumatoid arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Avascular necrosis Femoral neck fractures Hip osteoarthritis Post-traumatic osteoarthritis Rheumatoid arthritis Surgery Trochanteric fractures

Contacts and locations

Locations

  • Alleghany Health Network- Research Institute

    Pittsburgh, Pennsylvania, 15212, United States

  • Baylor Scott and White Medical Center

    Temple, Texas, 76508, United States

  • Midwest Orthopaedics at Rush

    Chicago, Illinois, 60612, United States

  • Northwell Health: University Orthopaedic Associates

    Great Neck, New York, 11021, United States

  • OrthoCarolina Research Institute

    Charlotte, North Carolina, 28207, United States

  • Orthopedic Physician Associates

    Seattle, Washington, 98122, United States

  • Providence Orthopedics and Sports Medicine

    Spokane, Washington, 99208, United States

  • Reno Orthopedic Center Foundation

    Reno, Nevada, 89503, United States

  • TOA Research Foundation

    Nashville, Tennessee, 37204, United States

  • The MORE Foundation

    Phoenix, Arizona, 85023, United States

  • University of California, San Francisco

    San Francisco, California, 94158, United States

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