Arthroplasty, Replacement, HipNCT00535626
Trident® Tritanium™ Acetabular Shell Revision Study
A study testing Trident® Tritanium™ Acetabular Shell in people with Arthroplasty, Replacement, Hip, run by Stryker Orthopaedics at 15 sites in United States.
Trial summary
The purpose of this study is to evaluate a hip implant system used when a previous hip replacement surgery has failed. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Arthroplasty, Replacement, Hip
- What is being tested?
- Trident® Tritanium™ Acetabular Shell
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 15 sitesUnited States
- Study dates
- Nov 2006to Sep 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and non-pregnant females, 21-85 years of age at the time of surgery.
- Patient is a candidate for a revision of a failed acetabular component with a cementless acetabular component.
- Patient has signed an IRB approved study consent form.
- Patient is willing and able to comply with postoperative requirements including postoperative weight bearing restrictions and self-evaluations.
Who cannot join
- Patient is morbidly obese, BMI > 40.
- Patient has a systemic or metabolic bone disorder leading to progressive bone deterioration.
- Patient is immunologically compromised or receiving steroids in excess of normal physiological requirements (> 30 days).
- Patient's bone stock is compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis.
- Patient has an active or suspected latent infection on or about the hip joint.
- Patient is a prisoner.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Crystal Clinic
Akron, Ohio, 44333
New England Baptist Hospital
Boston, Massachusetts, 02120
Cleveland Clinic
Cleveland, Ohio, 44195
Illinois Bone & Joint Institute
Glenview, Illinois, 60025
The Methodist Hospital
Houston, Texas, 77030
Heekin Institute for Orthopedic Research, Inc.
Jacksonville, Florida, 32204
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Louisville, 201 Abraham Flexner Way, Suite 100
Louisville, Kentucky, 40202
Cedars Medical Center
Miami, Florida, 33136
NYU Hospital for Joint Diseases
New York, New York, 10003
Hospital for Special Surgery
New York, New York, 10021
Orthopedic Specialty Institute
Orange, California, 92868
Rockwood Clinic
Spokane, Washington, 99202
Scott & White Memorial Hospital
Temple, Texas, 76508
St Joseph Mercy Hospital
Ypsilanti, Michigan, 48197
About this study
Official title: A Post-market, Non-randomized, Open Label, Multi-center Clinical Study of the Trident Tritanium Acetabular Shell
The purpose of this study is to evaluate a hip implant system used when a previous hip replacement surgery has failed.
Read the detailed description
Total hip replacement is considered to be a very successful surgical procedure for the treatment of degenerative joint disease. Clinical results for cementless acetabular components have demonstrated excellent long-term fixation of these devices. However, so called 'first generation' cementless acetabular components have not had similar success rates. In these cases the acetabular component is often revised due to loosening, wear or infection.
Revision hip arthroplasty also becomes a challenge as patients often present with severe bone loss and poor bone quality. This can lead to compromised initial stability, which in turn leads to lack of long-term fixation and failure. Acetabular revision with a cementless component has shown improved results over cemented fixation.
Radiographic evaluation of the Trident® Tritanium™ Acetabular Shell will provide valuable early to intermediate information that may help predict the long-term success of this new system.
It is the intention of this study to closely follow subjects that have undergone revision hip replacement with regard to implant survivorship, signs of radiographic loosening, subjects' function evaluated through Harris Hip Score and Lower Extremity Activity Scale, subject quality of life through SF-36 and adverse events.
The primary efficacy hypothesis is that the rate of revision or pending revision (as defined by radiographic parameters) due to instability or lack of fixation for the Trident® Tritanium™ Acetabular Shell will be less than 10% at 5 years.
- Conditions
- Arthroplasty, Replacement, Hip
- Being tested
- Trident® Tritanium™ Acetabular Shell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trident® Tritanium™ Acetabular ShellDevice
Trident® Tritanium™ Acetabular Shell
| Study group | Role | What they receive |
|---|---|---|
| Trident® Tritanium™ Acetabular Shell | Other | Trident® Tritanium™ Acetabular Shell used in revision total hip replacement Receives: Device: Trident® Tritanium™ Acetabular Shell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Hips Requiring Revision or Pending Revision of the Acetabular Shell (as Defined by Radiographic Parameters) Due to Instability or Lack of Fixation
Measured: 5 years post-operative
Secondary outcomes (5)
Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits
The change in HHS is reported by comparing the mean pre-operative, 3-month, 1, 2, 3, 4, and 5 year post-operative scores. Scores can range from 0 to 100, with 0 being the worst and 100 being the best score. 90-100 = excellent, 80-89 = good, 70-79 = fair, 0-69 = poor.
Measured: pre-op, 3 month, 1, 2, 3, 4, 5 years
Change in SF-36 From Pre-operative to Post-operative Visits
The change in SF-36 is reported by comparing the mean preoperative, 3 month, 1, 2, 3, 4, and 5 year scores. The SF-36 Health Survey is a 36 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-op, 3 month, 1, 2, 3, 4, 5 years
Radiographic Outcomes: Radiolucency (RLL) Around the Acetabular Shell is Greater Than 2 mm in All Zones
Defined as a lucent area seen parallel and in close proximity to the device at the prosthesis/bone interface encompassing at least 50% of the zone, and at least 1 mm or greater in width. May be accompanied by a radiopaque (reactive) line. Assessed for each of the three modified DeLee Charnley zones.
Measured: 3 month, 1, 2, 3, 4, 5 years
Radiographic Outcomes: Migration of the Acetabular Shell Greater Than 5 mm in Any Direction
Defined as the measurable change in the acetabular shell position relative to reproducible bony landmarks.
Measured: 3 month, 1, 2, 3, 4, 5 years
Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative
The change in LEAS is reported by comparing the mean pre-operative, 3 month, 1, 2, 3, 4, and 5 year scores. 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: pre-op, 3 month, 1, 2, 3, 4, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startNov 2006
- Primary completionSep 2016
- Study completionSep 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
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arthur Malkani, MD, Study chair, University of LouisvilleMichael Masini, MD, Principal investigator, St Joseph Mercy HospitalDaniel Ward, MD, Principal investigator, New England Baptist HospitalBenjamin Bierbaum, MD, Principal investigator, New England Baptist HospitalKirby Hitt, MD, Principal investigator, Scott & White Memorial HospitalKenneth Greene, MD, Principal investigator, Crystal ClinicJim Kudrna, MD, Principal investigator, Illinois Bone & Joint InstituteIvan Tomek, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00535626
- Sponsor's protocol ID
- 61
- Status last verified
- Nov 2017
- First submitted
- 24 Sep 2007
- Last updated
- 20 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-market, Non-randomized, Open Label, Multi-center Clinical Study of the Trident Tritanium Acetabular Shell
- ClinicalTrials.gov ID
- NCT00535626
- Acronym / sponsor ID
- 61
- Conditions
- Arthroplasty, Replacement, Hip
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Stryker OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 26 Sep 2007 (estimated)
- Results
- Posted 20 Nov 2017
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 evaluate a hip implant system used when a previous hip replacement surgery has failed.
Detailed description
Total hip replacement is considered to be a very successful surgical procedure for the treatment of degenerative joint disease. Clinical results for cementless acetabular components have demonstrated excellent long-term fixation of these devices. However, so called 'first generation' cementless acetabular components have not had similar success rates. In these cases the acetabular component is often revised due to loosening, wear or infection.
Revision hip arthroplasty also becomes a challenge as patients often present with severe bone loss and poor bone quality. This can lead to compromised initial stability, which in turn leads to lack of long-term fixation and failure. Acetabular revision with a cementless component has shown improved results over cemented fixation.
Radiographic evaluation of the Trident® Tritanium™ Acetabular Shell will provide valuable early to intermediate information that may help predict the long-term success of this new system.
It is the intention of this study to closely follow subjects that have undergone revision hip replacement with regard to implant survivorship, signs of radiographic loosening, subjects' function evaluated through Harris Hip Score and Lower Extremity Activity Scale, subject quality of life through SF-36 and adverse events.
The primary efficacy hypothesis is that the rate of revision or pending revision (as defined by radiographic parameters) due to instability or lack of fixation for the Trident® Tritanium™ Acetabular Shell will be less than 10% at 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trident® Tritanium™ Acetabular Shell | Other | Device: Trident® Tritanium™ Acetabular ShellTrident® Tritanium™ Acetabular Shell used in revision total hip replacement |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and non-pregnant females, 21-85 years of age at the time of surgery.
- Patient is a candidate for a revision of a failed acetabular component with a cementless acetabular component.
- Patient has signed an IRB approved study consent form.
- Patient is willing and able to comply with postoperative requirements including postoperative weight bearing restrictions and self-evaluations.
Key exclusion criteria (6 listed)
- Patient is morbidly obese, BMI > 40.
- Patient has a systemic or metabolic bone disorder leading to progressive bone deterioration.
- Patient is immunologically compromised or receiving steroids in excess of normal physiological requirements (> 30 days).
- Patient's bone stock is compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis.
- Patient has an active or suspected latent infection on or about the hip joint.
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® Tritanium™ Acetabular ShellTrident® Tritanium™ Acetabular Shell | Device | Trident® Tritanium™ Acetabular Shell |
Primary outcome
Number of Hips Requiring Revision or Pending Revision of the Acetabular Shell (as Defined by Radiographic Parameters) Due to Instability or Lack of Fixation
Time frame: 5 years post-operative
5 secondary outcomes
Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits
Time frame: pre-op, 3 month, 1, 2, 3, 4, 5 years
Change in SF-36 From Pre-operative to Post-operative Visits
Time frame: pre-op, 3 month, 1, 2, 3, 4, 5 years
Radiographic Outcomes: Radiolucency (RLL) Around the Acetabular Shell is Greater Than 2 mm in All Zones
Time frame: 3 month, 1, 2, 3, 4, 5 years
Radiographic Outcomes: Migration of the Acetabular Shell Greater Than 5 mm in Any Direction
Time frame: 3 month, 1, 2, 3, 4, 5 years
Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative
Time frame: pre-op, 3 month, 1, 2, 3, 4, 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
- 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.
Arthur Malkani, MD study chair
University of Louisville
Michael Masini, MD principal investigator
St Joseph Mercy Hospital
Daniel Ward, MD principal investigator
New England Baptist Hospital
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trident® Tritanium™ Acetabular Shell in people with Arthroplasty, Replacement, Hip, run by Stryker Orthopaedics at 15 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 6 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 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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 20 Nov 2017). 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 Hips Requiring Revision or Pending Revision of the Acetabular Shell (as Defined by Radiographic Parameters) Due to Instability or Lack of Fixation (time frame: 5 years post-operative). 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 20 Nov 2017.