Arthroplasty, Hip RevisionNCT04317586
Trident II Revision Outcomes Study
A study testing Trident II Tritanium Acetabular Shell for Revision in people with Arthroplasty, Hip Revision, run by Stryker Orthopaedics at 10 sites in United States.
Trial summary
The purpose of this study is to review the performance and success rate of an FDA cleared 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 85 years
- Conditions the study is for
- Arthroplasty, Hip Revision
- What is being tested?
- Trident II Tritanium Acetabular Shell for Revision
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 10 sitesUnited States
- Study dates
- 23 Jun 2020to 27 Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has signed an IRB approved, study specific Informed Patient Consent Form.
- Patient is a male or non-pregnant female age 18-85 years of age at the time of study device implantation.
- Patient is a candidate for a revision of a failed acetabular component with a cementless acetabular component.
- Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations.
Who cannot join
- Patient has a Body Mass Index (BMI) > 45. F. Patient is diagnosed with Inflammatory Arthritis. G. Patient has a non-Stryker retained stem. H. Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.
- Patient has a mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
- Patient has compromised bone stock which cannot provide adequate support and/or fixation to the prosthesis.
- 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). M. Patient has a known sensitivity to device materials. N. Patient is a prisoner.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
OrthoNY
Albany, New York, 12205
Massachusetts General Hospital
Boston, Massachusetts, 02114
Lafayette General Orthopedic Center
Lafayette, Louisiana, 70506
The Orthopaedic & Fracture Clinic, P.A.
Mankato, Minnesota, 56001
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Syracuse Orthopedic Specialists
New York, New York, 13214
Reno Orthopedic Center Foundation
Reno, Nevada, 89503
Beaumont Hospital Research Institute
Royal Oak, Michigan, 48073
University of Utah
Salt Lake City, Utah, 84108
University of Massachusetts
Worcester, Massachusetts, 01605
About this study
Official title: A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Trident II Acetabular Shell in a Revision Indication
The purpose of this study is to review the performance and success rate of an FDA cleared 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.
- Conditions
- Arthroplasty, Hip Revision
- Being tested
- Trident II Tritanium Acetabular Shell for Revision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trident II Tritanium Acetabular Shell for RevisionDevice
A hemispherical acetabular shell indicated for cementless application in a previously failed total hip arthroplasty (THA)
| Study group | Role | What they receive |
|---|---|---|
| Trident II Tritanium Acetabular Shell for Revision | Other | Not described Receives: Device: Trident II Tritanium Acetabular Shell for Revision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Cases Free From Trident II Acetabular Shell Revision
To demonstrate, through absence of revision for aseptic loosening at five years postoperative, that acetabular revision with the Trident II Acetabular Shell provides clinical results comparable to similar acetabular components for revision indications. The study was terminated prior to the 5-year timepoint, data is presented through 2-years postoperative.
Measured: 6 Weeks, 3-6 Months, 1 Year and 2 Years
Secondary outcomes (1)
Radiographic Stability
Radiographic stability is a composite endpoint evaluating radiolucency and migration. Radiographic stability is defined as cases (hips implanted) which do not present with migration of greater than 5 mm in any direction or at least 2 mm radiolucency in all zones.
Measured: 6 Weeks and 3-6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start23 Jun 2020
- Primary completion27 Jan 2023
- Study completion27 Jan 2023
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arthroplasty, Hip RevisionStudies 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04317586
- Sponsor's protocol ID
- 79
- Status last verified
- Nov 2023
- First submitted
- 12 Mar 2020
- Last updated
- 1 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Trident II Acetabular Shell in a Revision Indication
- ClinicalTrials.gov ID
- NCT04317586
- Acronym / sponsor ID
- 79
- Conditions
- Arthroplasty, Hip Revision
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Stryker OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2020 (actual)
- Primary completion
- 27 Jan 2023 (actual)
- Study completion
- 27 Jan 2023 (actual)
- First posted
- 23 Mar 2020 (actual)
- Results
- Posted 1 Dec 2023
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 cleared 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.
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 for Revision | Other | Device: Trident II Tritanium Acetabular Shell for Revision |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient has signed an IRB approved, study specific Informed Patient Consent Form.
- Patient is a male or non-pregnant female age 18-85 years of age at the time of study device implantation.
- Patient is a candidate for a revision of a failed acetabular component with a cementless acetabular component.
- Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations.
Key exclusion criteria (5 listed)
- Patient has a Body Mass Index (BMI) > 45. F. Patient is diagnosed with Inflammatory Arthritis. G. Patient has a non-Stryker retained stem. H. Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.
- Patient has a mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
- Patient has compromised bone stock which cannot provide adequate support and/or fixation to the prosthesis.
- 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). M. Patient has a known sensitivity to device materials. N. Patient is a prisoner.
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 Shell for RevisionA hemispherical acetabular shell indicated for cementless application in a previously failed total hip arthroplasty (THA) | Device | Trident II Tritanium Acetabular Shell for Revision |
Primary outcome
Number of Cases Free From Trident II Acetabular Shell Revision
Time frame: 6 Weeks, 3-6 Months, 1 Year and 2 Years
To demonstrate, through absence of revision for aseptic loosening at five years postoperative, that acetabular revision with the Trident II Acetabular Shell provides clinical results comparable to similar acetabular components for revision indications. The study was terminated prior to the 5-year timepoint, data is presented through 2-years postoperative.
1 secondary outcome
Radiographic Stability
Time frame: 6 Weeks and 3-6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 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 for Revision in people with Arthroplasty, Hip Revision, run by Stryker Orthopaedics at 10 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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
Yes. Results are posted in the registry (first posted 1 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Cases Free From Trident II Acetabular Shell Revision (time frame: 6 Weeks, 3-6 Months, 1 Year and 2 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 1 Dec 2023.