Arthroplasty, Replacement, HipNCT00958191
Trident® X3 Polyethylene Insert Study
A study testing Trident® X3 Polyethylene Insert in people with Arthroplasty, Replacement, Hip, run by Stryker Orthopaedics at 9 sites in United States.
Trial summary
The primary objective of the study is to demonstrate the linear wear rates of the Trident® X3 polyethylene insert are superior to a polyethylene control group wear rate at 5 years postoperative. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Arthroplasty, Replacement, Hip
- What is being tested?
- Trident® X3 Polyethylene Insert
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 9 sitesUnited States
- Study dates
- May 2005to Dec 2016
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient has signed an IRB-approved, study specific Patient Informed Consent Form.
- The patient is a candidate for a primary total hip replacement with cementless acetabular and femoral components.
- The patient has a primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD). Patient must have diagnosis of osteoarthritis (OA), traumatic arthritis (TA), avascular necrosis (AVN), slipped capital epiphysis, pelvic fracture, femoral fracture, failed fracture fixation, or diastrophic variant.
- The patient is a male or non-pregnant female patient ages 21 to 75.
- The patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Who cannot join
- The patient has an active infection with the affected hip joint.
- The patient requires revision surgery of a previously implanted total hip arthroplasty or hip fusion to the affected joint.
- The patient has a BMI >45.
- The patient has a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
- The patient has diagnosed systemic disease (i.e. Paget's disease, renal osteodystrophy).
- The patient is immunologically suppressed or receiving chronic steroids in excess of 5mg per day.
- The patient has a recent history of substance dependency that may result in deviations from the evaluation schedule.
- The patient is a prisoner.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Emory University
Atlanta, Georgia, 30329
New England Baptist Hospital
Boston, Massachusetts, 02120
University of Vermont College of Medicine
Burlington, Vermont, 05405
Bonutti Research Inc.
Effingham, Illinois, 62401
Indiana University
Indianapolis, Indiana, 46202-5111
Good Samaritan Hospital
Kearney, Nebraska, 68845
J. Wesley Mesko, MD
Lansing, Michigan, 48910
Greater Pittsburgh Orthopaedics Assoc
Pittsburgh, Pennsylvania, 15108-4305
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: An Open-label, Prospective, Post-market, Historically Controlled, Multi-center Clinical Evaluation of the Trident® X3 Polyethylene Acetabular Inserts.
The primary objective of the study is to demonstrate the linear wear rates of the Trident® X3 polyethylene insert are superior to a polyethylene control group wear rate at 5 years postoperative. This measurement will be evaluated by comparing digitized images of serial radiographs obtained over a follow-up period of 5-years.
Read the detailed description
The study is a prospective, multi-center, historical-controlled clinical evaluation of the Trident® X3 Polyethylene insert. The device is commercially available in the United States where the study is being conducted. The study device, the Stryker Orthopaedics Trident® X3 polyethylene insert, is used for the replacement of the bearing surface of the acetabulum to relieve pain, instability, and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, trauma, or failure of other devices. The control device, the Stryker Orthopaedics N2VAC polyethylene insert, is also used for the replacement of the bearing surface of the acetabulum to relieve pain, instability, and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, trauma, or failure of other devices.
- Conditions
- Arthroplasty, Replacement, Hip
- Being tested
- Trident® X3 Polyethylene Insert
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trident® X3 Polyethylene InsertDevice
Trident® X3 Polyethylene Insert
| Study group | Role | What they receive |
|---|---|---|
| Trident® X3 Polyethylene Insert | Other | Participants who received the Trident® X3 Polyethylene Insert. Receives: Device: Trident® X3 Polyethylene Insert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Linear Wear Rate at 5 Years
Linear wear rates are defined as the annual rate of removal of the polyethylene from the polyethylene insert determined by comparing digitized images of serial radiographs obtained over the follow-up period of 5 years
Measured: 5 years
Rate of Incidence of Revision of Component for Any Reason
Revision of any component is defined as surgical removal and replacement of the femoral component, acetabular shell, acetabular insert and/or femoral head.
Measured: 5 year
Secondary outcomes (9)
Linear Wear Rate of the Trident X3 Polyethylene Insert
Linear wear rates are defined as the annual rate of removal of the polyethylene from the polyethylene insert determined by comparing digitized images of serial radiographs obtained over the follow-up period.
NOTE: 2 year linear and volumetric wear was not calculated for the following reason: To determine polyethylene wear, the total femoral head penetration is first calculated from the radiographs.The femoral head penetration has two components namely wear and creep (or bedding-in). It is not possible to separate the total penetration in to two components. The creep of the polyethylene starts from the date of surgery and continues up to 12-24 months. Therefore, the head penetration value at 2-years is dominated by Creep rather than wear.
Measured: 2, 3 and 4 year films collected; 3 and 4 year wear assessed
Volumetric Wear Rate of the Trident X3 Polyethylene Insert
Volumetric wear rate is calculated using a formula based on the cylindrical wear pattern perpendicular to the face of the cup and the mean linear wear rate.
NOTE: 2 year linear and volumetric wear was not calculated for the following reason: To determine polyethylene wear, the total femoral head penetration is first calculated from the radiographs.The femoral head penetration has two components namely wear and creep (or bedding-in). It is not possible to separate the total penetration in to two components. The creep of the polyethylene starts from the date of surgery and continues up to 12-24 months. Therefore, the head penetration value at 2-years is dominated by Creep rather than wear.
Measured: 2, 3, 4 and 5 year films collected; 3, 4 and 5 year wear assessed
Radiographic Stability
Radiographic stability is defined as having all of the following: no radiographic indication of progressive radiolucent lines greater than or equal to 2 mm around the entire acetabular cup, no radiographic indication of acetabular cup migration of greater than or equal to 3 mm, no radiographic indication of progressive radiolucent lines greater than or equal to 2 mm around the entire femoral component, and no radiographic indication of progressive subsidence of the femoral component of greater than or equal to 5 mm. Radiographs are evaluated at 1,2,3,4 and 5 years.
Measured: 1,2,3,4 and 5 years
Mean Harris Hip Score (HHS) to Assess Change
The change in HHS is reported by comparing the mean preoperative, 1, 3 and 5 year postoperative scores that assess 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 less than or equal to 79 is considered fair-poor.
90 - 100 = excellent
80 - 89 = good
70 - 79 = fair
0 - 69 = poor
Measured: pre-operative, 1,3 and 5 years
Mean Harris Hip Score (HHS) Pain Score to Assess Change
The change in HHS Pain is reported by comparing the mean preoperative, 1, 3 and 5 year postoperative pain scores. Scores can range from 0 to 44, with 0 indicating totally disabling pain and 44 indicating no pain or pain that is ignored.
- None or ignores it = 44 points
- Slight, occasional, no compromise in activities = 40 points
- Mild pain, no effect on average activities, rarely moderate pain with unusual activity;may take aspirin = 30 points
- Moderate pain, tolerable, but makes concessions to pain. Some limitation of ordinary activity or work. May require occasional pain medication stronger than aspirin = 20 points
- Marked pain, serious limitation of activites = 10 points
- Totally disabled, crippled, pain in bed, bedridden = 0 points
Measured: pre-operative, 1,3, and 5 years
Mean Harris Hip Score (HHS) Range of Motion (ROM) Score to Assess Change
The change in HHS ROM is reported by comparing the mean preoperative, 1, 3 and 5 year postoperative scores. Scores can range from 0 (worst) to 5 (best). The degrees of motion are measured for hip flexion, abduction, adduction, external rotation and internal rotation. The measured values are added to determine a combined value that is associated with a score from 0 to 5.
- 211-300 degrees = 5 points
- 161 to 210 degrees = 4 points
- 101 to 160 degrees = 3 points
- 61 to 100 degrees = 2 points
- 31 to 60 degrees = 1 points
- 0 to 30 degrees = 0 points
Measured: pre-operative, 1,3 and 5 years
Mean SF-12 Health Survey Score to Assess Change
Change in the SF-12 score is reported by comparing the mean preoperative, 1,3 and 5 year postoperative 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: pre-operative, 1,3 and 5 years
Mean Lower Extremity Activity Scale (LEAS) Score to Assess Change
Change in the LEAS is reported by comparing the mean preoperative, 1,3 and 5 year scores. The LEAS is completed by the participant to assess activity level. Activity levels are ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.
Measured: pre-operative, 1,3 and 5 years
Implant Survivorship
Implant survivorship is determined using the Kaplan-Meier method.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2009 (estimated)
- Study startMay 2005
- Primary completionJul 2012
- Study completionDec 2016
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
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James D'Antonio, MD, Study chair, Greater Pittsburgh Orthopaedic AssociationBenjamin Bierbaum, MD, Principal investigator, New England Baptist Hospital Deptartment of OrthopaedicsPeter Bonutti, MD, Principal investigator, Bonutti ClinicWilliam Capello, MD, Principal investigator, Indiana University Medical CenterMichael Taunton, MD, Principal investigator, Mayo Clinic Department of Orthopaedic SurgeryRobert Johnson, MD, Principal investigator, University of Vermont College of Medicine Department of Orthopaedics & RehabilitationJ. Wesley Mesko, MD, Principal investigator, Michigan Orthopaedic CenterJames R Roberson, MD, Principal investigator, Emory Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00958191
- Sponsor's protocol ID
- 57
- Status last verified
- Jan 2018
- First submitted
- 11 Aug 2009
- Last updated
- 23 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Prospective, Post-market, Historically Controlled, Multi-center Clinical Evaluation of the Trident® X3 Polyethylene Acetabular Inserts.
- ClinicalTrials.gov ID
- NCT00958191
- Acronym / sponsor ID
- 57
- Conditions
- Arthroplasty, Replacement, Hip
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Stryker OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Jul 2012 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 13 Aug 2009 (estimated)
- Results
- Posted 14 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to demonstrate the linear wear rates of the Trident® X3 polyethylene insert are superior to a polyethylene control group wear rate at 5 years postoperative. This measurement will be evaluated by comparing digitized images of serial radiographs obtained over a follow-up period of 5-years.
Detailed description
The study is a prospective, multi-center, historical-controlled clinical evaluation of the Trident® X3 Polyethylene insert. The device is commercially available in the United States where the study is being conducted. The study device, the Stryker Orthopaedics Trident® X3 polyethylene insert, is used for the replacement of the bearing surface of the acetabulum to relieve pain, instability, and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, trauma, or failure of other devices. The control device, the Stryker Orthopaedics N2VAC polyethylene insert, is also used for the replacement of the bearing surface of the acetabulum to relieve pain, instability, and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, trauma, or failure of other devices.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trident® X3 Polyethylene Insert | Other | Device: Trident® X3 Polyethylene InsertParticipants who received the Trident® X3 Polyethylene Insert. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient has signed an IRB-approved, study specific Patient Informed Consent Form.
- The patient is a candidate for a primary total hip replacement with cementless acetabular and femoral components.
- The patient has a primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD). Patient must have diagnosis of osteoarthritis (OA), traumatic arthritis (TA), avascular necrosis (AVN), slipped capital epiphysis, pelvic fracture, femoral fracture, failed fracture fixation, or diastrophic variant.
- The patient is a male or non-pregnant female patient ages 21 to 75.
- The patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Key exclusion criteria (8 listed)
- The patient has an active infection with the affected hip joint.
- The patient requires revision surgery of a previously implanted total hip arthroplasty or hip fusion to the affected joint.
- The patient has a BMI >45.
- The patient has a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
- The patient has diagnosed systemic disease (i.e. Paget's disease, renal osteodystrophy).
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® X3 Polyethylene InsertTrident® X3 Polyethylene Insert | Device | Trident® X3 Polyethylene Insert |
Primary outcome
Mean Linear Wear Rate at 5 Years
Time frame: 5 years
Linear wear rates are defined as the annual rate of removal of the polyethylene from the polyethylene insert determined by comparing digitized images of serial radiographs obtained over the follow-up period of 5 years
Rate of Incidence of Revision of Component for Any Reason
Time frame: 5 year
Revision of any component is defined as surgical removal and replacement of the femoral component, acetabular shell, acetabular insert and/or femoral head.
9 secondary outcomes
Linear Wear Rate of the Trident X3 Polyethylene Insert
Time frame: 2, 3 and 4 year films collected; 3 and 4 year wear assessed
Volumetric Wear Rate of the Trident X3 Polyethylene Insert
Time frame: 2, 3, 4 and 5 year films collected; 3, 4 and 5 year wear assessed
Radiographic Stability
Time frame: 1,2,3,4 and 5 years
Mean Harris Hip Score (HHS) to Assess Change
Time frame: pre-operative, 1,3 and 5 years
Mean Harris Hip Score (HHS) Pain Score to Assess Change
Time frame: pre-operative, 1,3, and 5 years
Mean Harris Hip Score (HHS) Range of Motion (ROM) Score to Assess Change
Time frame: pre-operative, 1,3 and 5 years
Mean SF-12 Health Survey Score to Assess Change
Time frame: pre-operative, 1,3 and 5 years
Mean Lower Extremity Activity Scale (LEAS) Score to Assess Change
Time frame: pre-operative, 1,3 and 5 years
Implant Survivorship
Time frame: 10 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
- 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.
James D'Antonio, MD study chair
Greater Pittsburgh Orthopaedic Association
Benjamin Bierbaum, MD principal investigator
New England Baptist Hospital Deptartment of Orthopaedics
Peter Bonutti, MD principal investigator
Bonutti Clinic
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® X3 Polyethylene Insert 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 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: finished, as of the sponsor's last update on 23 Feb 2018. 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?
Yes. Results are posted in the registry (first posted 14 Jul 2014). 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?
Mean Linear Wear Rate at 5 Years (time frame: 5 years). The study lists 2 primary outcomes in all. 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 23 Feb 2018.