Arthroplasty, Replacement, HipNCT01063751
Tritanium® Primary Acetabular Shell Study
A study testing Tritanium® Primary Acetabular Shell in people with Arthroplasty, Replacement, Hip, run by Stryker Orthopaedics at 7 sites in United States.
Trial summary
This study will be a prospective, non-randomized evaluation of the Tritanium® Acetabular Shell for primary total hip replacement (THR) with a cementless application in a consecutive series of patients who meet the eligibility criteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Hip
- What is being tested?
- Tritanium® Primary Acetabular Shell
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- 7 sitesUnited States
- Study dates
- Jul 2011to 30 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A. Patient has signed an IRB approved, study specific Informed Patient Consent Form.
- B. Patient is a male or non-pregnant female age 18 years or older at time of study device implantation.
- C. Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
- 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 and rehabilitation.
Who cannot join
- F. Patient has a Body Mass Index (BMI) ≥ 40.
- G. Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.
- H. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
- I. 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.
- J. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
- K. Patient requires revision surgery of a previously implanted total hip replacement or hip fusion to the affected joint.
- L. Patient has a known sensitivity to device materials.
- M. Patient is a prisoner.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Northern Light Eastern Maine Medical Center
Bangor, Maine, 04401
Center for Orthopaedics and Spine, LLP
Lake Charles, Louisiana, 70601
University of Kentucky Research Foundation
Lexington, Kentucky, 40536
West Virginia University
Morgantown, West Virginia, 26506
Adventist Health St. Helena
St. Helena, California, 94574
Syracuse Orthopedic Specialists, P.C.
Syracuse, New York, 13214
Florida Medical Clinic
Tampa, Florida, 33542
About this study
Official title: A Prospective, Post-market, Multi-center Study of the Tritanium® Acetabular Shell
This study will be a prospective, non-randomized evaluation of the Tritanium® Acetabular Shell for primary total hip replacement (THR) with a cementless application in a consecutive series of patients who meet the eligibility criteria. Half of the cases will use the Trident® X3® polyethylene insert alone as the bearing surface; the other half will use the modular dual mobility (MDM™) liner coupled with a compatible anatomic dual mobility (ADM™)/MDM™ X3® insert as the bearing surface.
The success rate, defined as freedom from acetabular revision for any reason, for hips implanted with the Tritanium® Acetabular Shell, is no worse than for hips implanted with similar technology as reported in the literature and Trident® X3® Study historical control at 5 years postoperative.
Read the detailed description
The Tritanium® Acetabular Shell, cleared for use under FDA 510(k) K081171, is a hemispherical acetabular shell with a 3D surface for biological fixation, fabricated from Commercially Pure Titanium (CPTi). The shell is built upon the design features and clinical history of the existing Trident® Tritanium®, Trident® AD, and Trident® hemispherical acetabular (HA) shells. The device is designed with a roughened surface and high coefficient of friction to resist micromotion and promote initial fixation. The Tritanium® Acetabular Shell, intended for use in a cementless application, is available in sizes from 44 millimeter (mm) through 66 mm and is compatible with Trident® polyethylene insert and acetabular screws. This advanced technology is designed to address the need for improved initial and biological fixation. Data in support of these marketing claims will be collected in the Tritanium® Primary Acetabular Shell Study.
A prospective, post-market, multi-center design will be employed. Radiographs will be assessed by an independent reviewer.
Cases will be enrolled at 7 to 12 centers. The enrollment goal ranges from 20 to 34 cases implanted with the Tritanium® Acetabular Shell per center. The enrollment goal range is dependent upon the number of participating centers as well as the relative rates of enrollment of the two treatment groups. Although a range is presented, there is no maximum limit to the number of cases that a center may enroll. In the event that a center far exceeds the overall enrollment goal or enrollment into one of the treatment groups is completed, Stryker may ask the center to cease enrollment so as not to skew the data. All participating centers will comply with the federal regulations regarding patient informed consent and Institutional Review Board (IRB) approval. Non-compliance of a study center may result in termination of the center's participation in the study.
- Conditions
- Arthroplasty, Replacement, Hip
- Being tested
- Tritanium® Primary Acetabular Shell
- Keywords
- Osteoarthritis, Traumatic arthritis, Avascular Necrosis
- Medical subject headings
- Osteoarthritis, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tritanium® Primary Acetabular ShellDevice
Tritanium® Primary Acetabular Shell in total hip replacement.
| Study group | Role | What they receive |
|---|---|---|
| Tritanium® Primary Acetabular Shell | Other | Tritanium® Primary Acetabular Shell Receives: Device: Tritanium® Primary Acetabular Shell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of Acetabular Revision
To evaluate the success rate of cementless primary total hip replacement (THR) in hips implanted with the Tritanium® Acetabular Shell, as compared to the published results of similar acetabular components. Success will be defined as absence of acetabular shell revision for any reason at 5 years postoperative. It is expected that the survivorship of the Tritanium® Acetabular Shell group will be non-inferior to the survivorship reported in the literature for similar competitive devices.
Measured: 5 years
Secondary outcomes (7)
Rates of Screw Fixation Usage in the Tritanium® Acetabular Shell
Usage of bone screw fixation will be recorded and compared between the Tritanium® Acetabular Shell group and the Trident® Hemispherical Acetabular (HA) Shell group (Trident® X3® Polyethylene Insert Study).
Measured: Intraoperative
Harris Hip Score
The Harris Hip Score (HHS) assesses pain, function, joint deformity and range of motion. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor
Measured: 1, 3, and 5 years
Short Form- 12 (SF-12) Heath Survey Scores
The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.
Measured: 1, 3, and 5 years
Lower Extremity Activity Scale (LEAS) Score
The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.
Measured: 1, 3, and 5 years
EuroQol Five-Dimensional (EQ-5D)
The EuroQol five-dimensional (EQ-5D) is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D consists of 2 areas: the EQ visual analogue scale (EQ VAS) and EQ-5D descriptive system. The EQ VAS collects health state values using a 20 cm visual analogue scale with the endpoints labeled best imaginable health state at the top and worst imaginable health state at the bottom, having numeric values of 100 to 0 respectively. The EQ-5D Time Trade-off (TTO) descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/comfort and anxiety/depression. Each dimension has three levels: no problems, some problems and extreme problems, where an overall score of 1 represents full health.
The index values on a scale between -1 (low) and 1 (high) are showing the average health status. A low score shows worse health, and a high score shows better health.
Measured: 1,2,3,4, and 5 years
Follow-Up Questionnaire
The Follow-up Questionnaire is a short patient questionnaire intended to provide information on patient satisfaction, pain, and whether or not there have been any revisions or removals since the last follow-up visit. It consists of three questions:
- Patient satisfaction with the hip replacement
- Presence of any pain in the study hip
- Any surgeries performed on the study hip
Measured: 6, 7, 8, 9, and 10 years
Acetabular Shell Radiographic Stability
Numerous parameters will be reviewed by zone, including radiolucency and migration. All data will be evaluated in order to classify each case as stable or unstable.
Measured: 6 weeks, 1, 3, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2010 (estimated)
- Study startJul 2011
- Primary completion5 May 2022
- Study completion30 Dec 2023
Why it stopped: As longitudinal patient follow-up continues to lag, Stryker has determined that the study is no longer able to meet the regulatory requirements this study intends to support. Termination is not related to any safety concerns with the products.
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, 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
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin Kopko, MD, Principal investigator, Syracuse Orthopedic Specialists, P.C.John Noble, MD, Principal investigator, Center for Orthopaedics and Spine, LLPCarmen Crofoot, MD, Principal investigator, Northern Light Eastern Maine Medical CenterJohn Diana, MD, Principal investigator, Adventist Health St. HelenaStephen Duncan, MD, Principal investigator, University of Kentucky Research FoundationBrock Lindsey, MD, Principal investigator, West Virginia UniversityStephen Raterman, MD, Principal investigator, Florida Medical Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01063751
- Sponsor's protocol ID
- 69
- Status last verified
- Dec 2024
- First submitted
- 4 Feb 2010
- Last updated
- 16 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Post-market, Multi-center Study of the Tritanium® Acetabular Shell
- ClinicalTrials.gov ID
- NCT01063751
- Acronym / sponsor ID
- 69
- Conditions
- Arthroplasty, Replacement, Hip
- Keywords
- Osteoarthritis, Traumatic arthritis, Avascular Necrosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: As longitudinal patient follow-up continues to lag, Stryker has determined that the study is no longer able to meet the regulatory requirements this study intends to support. Termination is not related to any safety concerns with the products.
- Enrolment
- 275 participants (actual)
- Lead sponsor
- Stryker OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- 5 May 2022 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 5 Feb 2010 (estimated)
- Results
- Posted 16 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be a prospective, non-randomized evaluation of the Tritanium® Acetabular Shell for primary total hip replacement (THR) with a cementless application in a consecutive series of patients who meet the eligibility criteria. Half of the cases will use the Trident® X3® polyethylene insert alone as the bearing surface; the other half will use the modular dual mobility (MDM™) liner coupled with a compatible anatomic dual mobility (ADM™)/MDM™ X3® insert as the bearing surface.
The success rate, defined as freedom from acetabular revision for any reason, for hips implanted with the Tritanium® Acetabular Shell, is no worse than for hips implanted with similar technology as reported in the literature and Trident® X3® Study historical control at 5 years postoperative.
Detailed description
The Tritanium® Acetabular Shell, cleared for use under FDA 510(k) K081171, is a hemispherical acetabular shell with a 3D surface for biological fixation, fabricated from Commercially Pure Titanium (CPTi). The shell is built upon the design features and clinical history of the existing Trident® Tritanium®, Trident® AD, and Trident® hemispherical acetabular (HA) shells. The device is designed with a roughened surface and high coefficient of friction to resist micromotion and promote initial fixation. The Tritanium® Acetabular Shell, intended for use in a cementless application, is available in sizes from 44 millimeter (mm) through 66 mm and is compatible with Trident® polyethylene insert and acetabular screws. This advanced technology is designed to address the need for improved initial and biological fixation. Data in support of these marketing claims will be collected in the Tritanium® Primary Acetabular Shell Study.
A prospective, post-market, multi-center design will be employed. Radiographs will be assessed by an independent reviewer.
Cases will be enrolled at 7 to 12 centers. The enrollment goal ranges from 20 to 34 cases implanted with the Tritanium® Acetabular Shell per center. The enrollment goal range is dependent upon the number of participating centers as well as the relative rates of enrollment of the two treatment groups. Although a range is presented, there is no maximum limit to the number of cases that a center may enroll. In the event that a center far exceeds the overall enrollment goal or enrollment into one of the treatment groups is completed, Stryker may ask the center to cease enrollment so as not to skew the data. All participating centers will comply with the federal regulations regarding patient informed consent and Institutional Review Board (IRB) approval. Non-compliance of a study center may result in termination of the center's participation in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tritanium® Primary Acetabular Shell | Other | Device: Tritanium® Primary Acetabular ShellTritanium® Primary Acetabular Shell |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A. Patient has signed an IRB approved, study specific Informed Patient Consent Form.
- B. Patient is a male or non-pregnant female age 18 years or older at time of study device implantation.
- C. Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
- 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 and rehabilitation.
Key exclusion criteria (8 listed)
- F. Patient has a Body Mass Index (BMI) ≥ 40.
- G. Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.
- H. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
- I. 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.
- J. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
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 |
|---|---|---|
| Tritanium® Primary Acetabular ShellTritanium® Primary Acetabular Shell in total hip replacement. | Device | Tritanium® Primary Acetabular Shell |
Primary outcome
Absence of Acetabular Revision
Time frame: 5 years
To evaluate the success rate of cementless primary total hip replacement (THR) in hips implanted with the Tritanium® Acetabular Shell, as compared to the published results of similar acetabular components. Success will be defined as absence of acetabular shell revision for any reason at 5 years postoperative. It is expected that the survivorship of the Tritanium® Acetabular Shell group will be non-inferior to the survivorship reported in the literature for similar competitive devices.
7 secondary outcomes
Rates of Screw Fixation Usage in the Tritanium® Acetabular Shell
Time frame: Intraoperative
Harris Hip Score
Time frame: 1, 3, and 5 years
Short Form- 12 (SF-12) Heath Survey Scores
Time frame: 1, 3, and 5 years
Lower Extremity Activity Scale (LEAS) Score
Time frame: 1, 3, and 5 years
EuroQol Five-Dimensional (EQ-5D)
Time frame: 1,2,3,4, and 5 years
Follow-Up Questionnaire
Time frame: 6, 7, 8, 9, and 10 years
Acetabular Shell Radiographic Stability
Time frame: 6 weeks, 1, 3, 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- 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.
Kevin Kopko, MD principal investigator
Syracuse Orthopedic Specialists, P.C.
John Noble, MD principal investigator
Center for Orthopaedics and Spine, LLP
Carmen Crofoot, MD principal investigator
Northern Light Eastern Maine Medical Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tritanium® Primary Acetabular Shell in people with Arthroplasty, Replacement, Hip, run by Stryker Orthopaedics at 7 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 8 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 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 16 Jan 2024). 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?
Absence of Acetabular Revision (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 16 Apr 2025.