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Hip implant study pulled before it even started

NCT ID NCT05591859

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 planned to test a hip implant called the Restoration Anatomic Acetabular Shell in people needing revision surgery after a previous hip replacement failed. The goal was to see how well the implant holds up over time. However, the study was withdrawn before enrolling any participants, so no results are available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Restoration Anatomic Acetabular Shell (hip implant device)
What this could lead to
If successful, this could provide a reliable option for people needing hip revision surgery, potentially reducing the need for further operations.
What could go wrong
The study was withdrawn before any participants were enrolled, so no data is available. Hip revision surgery carries risks like infection, implant loosening, or fracture.

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.

Started

Mar 2024

Expected to finish

Mar 2036

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Subject is a candidate for a revision of a failed acetabular component with the Restoration Anatomic Acetabular Shell. * Subject has signed an IRB-approved, study specific Informed Consent Form (ICF). * Subject is skeletally mature. * Subject is a male or non-pregnant female. * Subject is willing and able to comply with postoperative scheduled clinical evaluations. Exclusion Criteria: * Subject has a non-Stryker retained stem at the time of study device implantation. * Subject has a Body Mass Index (BMI) \> 45. * Subject has an active or suspected latent infection in or about the affected hip joint at time of study device implantation. * Subject has a mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care. * Subject has compromised bone stock which cannot provide adequate support and/or fixation to the prosthesis. * Subject is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration. * Subject is immunologically suppressed or receiving steroids in an excess of normal physiological requirements (e.g. \> 30 days). * Subject has a known sensitivity to device materials. * Subject is a prisoner.

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Conditions

The condition(s) this trial relates to.

arthropathy osteoarthritis, hip

As listed by the trial registrant

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

Arthropathy Hip arthropathy Hip osteoarthritis

Contacts and locations

Locations

  • Regents of the University of Colorado

    Denver, Colorado, 80045, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.