New hip implant under review: will it last?
NCT ID NCT02999009
First seen Jun 27, 2026 · Last updated Jun 30, 2026 · Updated 2 times
Summary
This study follows 383 people who received a cementless hip replacement part called the Trident II Tritanium Acetabular Shell. Researchers want to see how many need a revision surgery within 5 years, compared to similar devices. The goal is to confirm the part works well and stays stable over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Trident II Tritanium Acetabular Shell (a cementless hip replacement part)
- What this could lead to
- If successful, this could confirm that the Trident II shell is a safe and durable option for hip replacement, reducing the need for early revision surgery.
- What could go wrong
- This is a post-market study, not a new treatment. Results may not apply to all patients, and some may still need revision due to loosening or other complications.
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
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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
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383 people
The number who actually took part.
- Started
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Jan 2017
- Expected to finish
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Mar 2031
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: A. Patient has signed an Institutional Review Board (IRB) approved, study specific Informed Patient Consent Form. B. Patient is a male or non-pregnant female age 18-80 years of age at the time of study device implantation. C. Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease. D. Patient is a candidate for a primary cementless total hip replacement. E. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations. Exclusion Criteria: F. Patient has a Body Mass Index (BMI) ≥ 40. G. Patient is diagnosed with Inflammatory Arthritis. H. Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation. I. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device. J. Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration. K. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days). L. Patient requires revision surgery of a previously implanted total hip replacement or hip fusion to the affected joint. M. Patient has had previous open surgery to the affected joint, not including arthroscopy. N. Patient requires implantation of a constrained liner. O. Patient has a known sensitivity to device materials. P. Patient is a prisoner.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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American Hip Institute
Des Plaines, Illinois, 60018, United States
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Center for Orthopaedics and Spine, LLC
Lake Charles, Louisiana, 70605, United States
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Hospital for Special Surgery
New York, New York, 10021, United States
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Northwell Health, Lenox Hill Hospital
New York, New York, 10075, United States
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Rothman Institute
Egg Harbor, New Jersey, 08234, United States
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Southeast Orthopedic Specialists
Jacksonville, Florida, 32204, United States
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St. Joseph Mercy Hospital Health System
Ypsilanti, Michigan, 48197, United States
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Tucson Orthopaedic Institute
Tucson, Arizona, 85712, United States
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UNC Orthopaedics
Chapel Hill, North Carolina, 27599, United States
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