Arthroplasty, Replacement, HipNCT02999009
Trident II Tritanium Acetabular Shell Outcomes Study
A study testing Trident II Tritanium Acetabular Shell in people with Arthroplasty, Replacement, Hip, run by Stryker Orthopaedics at 9 sites in United States.
Trial summary
The purpose of this study is to review the performance and success rate of an FDA approved cementless hip replacement part called the Trident II Tritanium Acetabular Shell. The study will specifically look at the need to revise the hip replacement after 5 years. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arthroplasty, Replacement, Hip
- What is being tested?
- Trident II Tritanium Acetabular Shell
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 383 participants
- Where
- 9 sitesUnited States
- Study dates
- 20 Jan 2017to Mar 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has signed an Institutional Review Board (IRB) approved, study specific Informed Patient Consent Form.
- Patient is a male or non-pregnant female age 18-80 years of age at the time of study device implantation.
- Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease.
- Patient is a candidate for a primary cementless total hip replacement.
- Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations.
Who cannot join
- Patient has a Body Mass Index (BMI) ≥ 40.
- Patient is diagnosed with Inflammatory Arthritis.
- Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.
- Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
- 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.
- Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
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- Patient requires revision surgery of a previously implanted total hip replacement or hip fusion to the affected joint.
- Patient has had previous open surgery to the affected joint, not including arthroscopy.
- Patient requires implantation of a constrained liner.
- Patient has a known sensitivity to device materials.
- Patient is a prisoner.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
UNC Orthopaedics
Chapel Hill, North Carolina, 27599
American Hip Institute
Des Plaines, Illinois, 60018
Rothman Institute
Egg Harbor, New Jersey, 08234
Southeast Orthopedic Specialists
Jacksonville, Florida, 32204
Center for Orthopaedics and Spine, LLC
Lake Charles, Louisiana, 70605
Hospital for Special Surgery
New York, New York, 10021
Northwell Health, Lenox Hill Hospital
New York, New York, 10075
Tucson Orthopaedic Institute
Tucson, Arizona, 85712
St. Joseph Mercy Hospital Health System
Ypsilanti, Michigan, 48197
About this study
Official title: A Prospective, Post-market, Multi-center Study of the Trident II Tritanium Acetabular Shell
The purpose of this study is to review the performance and success rate of an FDA approved cementless hip replacement part called the Trident II Tritanium Acetabular Shell. The study will specifically look at the need to revise the hip replacement after 5 years. This will be compared to how much this happens in patients who have hip replacement with similar cementless acetabular shells.
Read the detailed description
This study is a prospective, open-label, post-market, non-randomized evaluation of the Trident II Tritanium Acetabular Shell for primary total hip arthroplasty (THA) with a cementless application in a consecutive series of patients who meet the eligibility criteria.
- Conditions
- Arthroplasty, Replacement, Hip
- Being tested
- Trident II Tritanium Acetabular Shell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trident II Tritanium Acetabular ShellDevice
A hemispherical acetabular shell indicated for cementless application.
| Study group | Role | What they receive |
|---|---|---|
| Trident II Tritanium Acetabular Shell | Other | The Trident II Tritanium Acetabular Shell is a hemispherical acetabular shell intended for use in a cementless application. Receives: Device: Trident II Tritanium Acetabular Shell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of Revision for the Trident II Tritanium Acetabular Shell
To demonstrate that acetabular replacement with the Trident II Tritanium Acetabular Shell provides clinical results comparable to similar acetabular components.
Measured: 5 years
Secondary outcomes (2)
All-cause Revision and Removal Rates for the Trident II Tritanium Acetabular Shell
Survivorship percentage (one reported value) for both all-cause revision + removal will be indicated
Measured: 10 years
Radiographic Stability
Numerous parameters will be reviewed by zone, including radiolucency and migration.
Measured: 6 weeks, 3-6 months, 1, 2, 5, 7, 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study start20 Jan 2017
- Primary completion10 Jun 2026
- Study completionMar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 383 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin Barga, Study director, Director, Clinical Research - Stryker Joint Replacement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02999009
- Sponsor's protocol ID
- 78
- Status last verified
- Jun 2026
- First submitted
- 12 Dec 2016
- Last updated
- 29 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Post-market, Multi-center Study of the Trident II Tritanium Acetabular Shell
- ClinicalTrials.gov ID
- NCT02999009
- Acronym / sponsor ID
- 78
- Conditions
- Arthroplasty, Replacement, Hip
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 383 participants (actual)
- Lead sponsor
- Stryker OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2017 (actual)
- Primary completion
- 10 Jun 2026 (actual)
- Study completion
- Mar 2031 (estimated)
- First posted
- 21 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to review the performance and success rate of an FDA approved cementless hip replacement part called the Trident II Tritanium Acetabular Shell. The study will specifically look at the need to revise the hip replacement after 5 years. This will be compared to how much this happens in patients who have hip replacement with similar cementless acetabular shells.
Detailed description
This study is a prospective, open-label, post-market, non-randomized evaluation of the Trident II Tritanium Acetabular Shell for primary total hip arthroplasty (THA) with a cementless application in a consecutive series of patients who meet the eligibility criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trident II Tritanium Acetabular Shell | Other | Device: Trident II Tritanium Acetabular ShellThe Trident II Tritanium Acetabular Shell is a hemispherical acetabular shell intended for use in a cementless application. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient has signed an Institutional Review Board (IRB) approved, study specific Informed Patient Consent Form.
- Patient is a male or non-pregnant female age 18-80 years of age at the time of study device implantation.
- Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease.
- Patient is a candidate for a primary cementless total hip replacement.
- Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations.
Key exclusion criteria (11 listed)
- Patient has a Body Mass Index (BMI) ≥ 40.
- Patient is diagnosed with Inflammatory Arthritis.
- Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.
- Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trident II Tritanium Acetabular ShellA hemispherical acetabular shell indicated for cementless application. | Device | Trident II Tritanium Acetabular Shell |
Primary outcome
Absence of Revision for the Trident II Tritanium Acetabular Shell
Time frame: 5 years
To demonstrate that acetabular replacement with the Trident II Tritanium Acetabular Shell provides clinical results comparable to similar acetabular components.
2 secondary outcomes
All-cause Revision and Removal Rates for the Trident II Tritanium Acetabular Shell
Time frame: 10 years
Radiographic Stability
Time frame: 6 weeks, 3-6 months, 1, 2, 5, 7, 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Barga study director
Director, Clinical Research - Stryker Joint Replacement
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trident II Tritanium Acetabular Shell in people with Arthroplasty, Replacement, Hip, run by Stryker Orthopaedics at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence of Revision for the Trident II Tritanium Acetabular Shell (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026; AzTrials last refreshed its copy on 27 Oct 2026.