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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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.

City, postcode or hospital

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

Other trials in United States

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

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 groups in NCT04317586
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.

23 Jun 202027 Jan 2023

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
CLinical Evaluation of ANtiseptic Skin Preparation in Revision Total Joint Arthroplasty of the Hip and Knee
Revision Total Hip Arthroplasty (RTHA), Revision Total Knee Arthroplasty
RecruitingObservational study
Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Revision Hip Prosthesis System
Revision Hip Arthroplasty, Aseptic Loosening of Prosthetic Joint
RecruitingObservational study
Prospective Follow-up of the Prevision Hip Stem With Comparison of Different Implant Variants
Revision Total Hip Arthroplasty, Periprosthetic Fracture of Hip
Active, not recruiting
Exercise Intervention Targeting Hip Strengthening Compared to Usual Care in Patients Undergoing Revision Hip Replacement
Revision Total Hip Arthroplasty
Enrolling by invitationObservational study
Infection-related Revision Rates After Single-dose Versus Multiple-dose Antibiotic Prophylaxis in Primary Hip and Knee Arthroplasty: a Comparative Implementation Study.
Total Hip Arthroplasty (THA), Antibiotic Prophylaxis

All Arthroplasty, Hip Revision trials

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.

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

Results posted to the registry on 1 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Trident II Tritanium Acetabular Shell for Revision	16	0

Primary outcome: Number of Cases Free From Trident II Acetabular Shell Revision

Time frame: 6 Weeks, 3-6 Months, 1 Year and 2 Years. Count of units. Unit: Hips Implanted

Measure	Trident II Tritanium Acetabular Shell for Revision n = 13
Number of Hips Free From Revision at 6 Weeks	14
Number of Hips Free From Revision at 3-6 Months	11
Number of Hips Free From Revision at 1 Year	8
Number of Hips Free From Revision at 2 Years	2

Population analysed: One subject (1 Hip Implanted) did not return for a 6-Week Post-Operative Visit. Data are presented for 14 implanted for latest follow-up timepoint reached by each subject; presented at 6 Weeks (N=14 Hips Implanted), 3-6 Months (N=11 Hips Implanted), 1 Year (N=8 Hips Implanted) and 2 Years (N=2 Hips Implanted).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data was collected from date of surgery to date of early termination, which was up to the 2 Year timepoint for the earliest enrolled subject.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Trident II Tritanium Acetabular Shell for Revision	1 of 14 (7.1%)	0 of 14 (0%)	0 of 14

Limitations and caveats (from the sponsor): Limitation: Early termination leading to small numbers of subjects analyzed due to lack of enrollment. The Secondary Outcome of Radiographic Stability was corrected and adjusted to tabular presentation in alignment with the pre-specified endpoint in the study protocol, which is a composite endpoint of both Radiolucency and Migration. Radiographic Radiolucency as a standalone Secondary Outcome Measure was erroneously submitted in the original posting.

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.

Related trials for Arthroplasty, Hip Revision

Active, not recruiting
CLinical Evaluation of ANtiseptic Skin Preparation in Revision Total Joint Arthroplasty of the Hip and Knee
Revision Total Hip Arthroplasty (RTHA), Revision Total Knee Arthroplasty
RecruitingObservational study
Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Revision Hip Prosthesis System
Revision Hip Arthroplasty, Aseptic Loosening of Prosthetic Joint
RecruitingObservational study
Prospective Follow-up of the Prevision Hip Stem With Comparison of Different Implant Variants
Revision Total Hip Arthroplasty, Periprosthetic Fracture of Hip
Active, not recruiting
Exercise Intervention Targeting Hip Strengthening Compared to Usual Care in Patients Undergoing Revision Hip Replacement
Revision Total Hip Arthroplasty
Enrolling by invitationObservational study
Infection-related Revision Rates After Single-dose Versus Multiple-dose Antibiotic Prophylaxis in Primary Hip and Knee Arthroplasty: a Comparative Implementation Study.
Total Hip Arthroplasty (THA), Antibiotic Prophylaxis

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?

On the ClinicalTrials.gov record for NCT04317586.

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; AzTrials last refreshed its copy on 27 Oct 2026.