Radiostereometric AnalysisNCT01754155
A Prospective Radiostereometric Analysis and Clinical Evaluation of the Zimmer® Continuum® Acetabular Cup With Vitamin E Stabilized Polyethylene
A study testing RSA images in people with Radiostereometric Analysis and Vitamin E Liner, run by Central DuPage Hospital at 1 site in United States.
Trial summary
The purpose of this study is to use Radiostereometric Analysis (RSA) and clinical outcome measures to evaluate early, post-operative implant stability, post-operative implant fixation, clinical performance, and in-vivo wear of the Zimmer® Continuum® Cup with vitamin E stabilized polyethylene. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Radiostereometric Analysis, Vitamin E Liner, Zimmer® Continuum® Acetabular Cup
- What is being tested?
- RSA images
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic osteoarthritis of the hip indicating surgical intervention
- Scheduled to undergo an uncemented total hip arthroplasty (THA)
- Patients between the ages of 18 and 65, inclusive
- Ability to give informed consent
- Patients will be available for follow-up for a minimum of 2 years after surgery
Who cannot join
- Patients less than 18 years of age, or older than 65 years of age.
- Post-traumatic arthritis in the affected hip
- Rheumatoid arthritis in the affected hip
- Hip dysplasia in the affected hip
- Prior arthroplasty of the affected hip
- Active or prior infection of the affected hip
Show all 15Show fewer
- Morbid obesity (BMI > 35)
- Medical condition precluding major surgery
- Severe osteoporosis or osteopenia
- Neuromuscular impairment
- Patients with known allergy to metals
- Pregnancy
- Patients with compromised kidney function
- Patient is immuno-suppressed
- Patients that require a femoral head less than 32 mm or greater than 40mm.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Central DuPage Hospital
Winfield, Illinois, 60190
Miller, 630-933-6254
Scott Sporer, MD
About this study
The purpose of this study is to use Radiostereometric Analysis (RSA) and clinical outcome measures to evaluate early, post-operative implant stability, post-operative implant fixation, clinical performance, and in-vivo wear of the Zimmer® Continuum® Cup with vitamin E stabilized polyethylene.
- Being tested
- RSA images
- Keywords
- Vitamin E, Zimmer, RSA, Radiostereometric Analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSA imagesRadiation
All subjects will have the Vitamin E polyethylene and RSA beads placed during surgery. Subjects will then have standard x-ray images and RSA images taken at specific time points up until 2 years post-operatively.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin E Polyethylene and RSA | Other | All subjects will have the Vitamin E polyethylene and RSA beads placed during surgery. Subjects will then have standard x-ray images and RSA images taken at specific time points up until 2 years post-operatively. Receives: Radiation: RSA images |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the Continuum® Cup for adequate fixation to the underlying bone as measured by migration and tilt
Measured: 2 years
Assessing the migration pattern of the Continuum® Cup
Measured: 2 years
Determining a correlation between radiolucent lines (RLLs) measured by Charnley-DeLee Zone Analyses and migration characteristics using RSA
Measured: 2 years
Determine if inducible displacement is indicative of adequate fixation
Measured: 2 years
Assess the health status and functional outcome of patients with the Continuum® Cup
Measured: 2 years
Assess the wear rate of the Vitamin E polyethylene with a ceramic femoral head
Measured: 2 years
Determine if the wear rate of the Vitamin E liner is the same in-vivo as it is in simulation testing
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiostereometric AnalysisStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central DuPage Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet, Halifax Biomedical Inc.
- Responsible party
- Sponsor
- Investigators
- Scott Sporer, MD, Principal investigator, Central DuPage Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01754155
- Sponsor's protocol ID
- CW55584
- Status last verified
- Aug 2017
- First submitted
- 18 Dec 2012
- Last updated
- 24 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Radiostereometric Analysis and Clinical Evaluation of the Zimmer® Continuum® Acetabular Cup With Vitamin E Stabilized Polyethylene
- ClinicalTrials.gov ID
- NCT01754155
- Acronym / sponsor ID
- CW55584
- Keywords
- Vitamin E, Zimmer, RSA, Radiostereometric Analysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Central DuPage HospitalUniversity, hospital or other
- Collaborators
- Zimmer Biomet, Halifax Biomedical Inc.
- Study start
- Jan 2013
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 21 Dec 2012 (estimated)
- Results
- Not posted in the source record
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 use Radiostereometric Analysis (RSA) and clinical outcome measures to evaluate early, post-operative implant stability, post-operative implant fixation, clinical performance, and in-vivo wear of the Zimmer® Continuum® Cup with vitamin E stabilized polyethylene.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin E Polyethylene and RSA | Other | Radiation: RSA imagesAll subjects will have the Vitamin E polyethylene and RSA beads placed during surgery. Subjects will then have standard x-ray images and RSA images taken at specific time points up until 2 years post-operatively. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Symptomatic osteoarthritis of the hip indicating surgical intervention
- Scheduled to undergo an uncemented total hip arthroplasty (THA)
- Patients between the ages of 18 and 65, inclusive
- Ability to give informed consent
- Patients will be available for follow-up for a minimum of 2 years after surgery
Key exclusion criteria (15 listed)
- Patients less than 18 years of age, or older than 65 years of age.
- Post-traumatic arthritis in the affected hip
- Rheumatoid arthritis in the affected hip
- Hip dysplasia in the affected hip
- Prior arthroplasty of the affected hip
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 |
|---|---|---|
| RSA imagesAll subjects will have the Vitamin E polyethylene and RSA beads placed during surgery. Subjects will then have standard x-ray images and RSA images taken at specific time points up until 2 years post-operatively. | Radiation | Vitamin E Polyethylene and RSA |
Primary outcome
Assessing the Continuum® Cup for adequate fixation to the underlying bone as measured by migration and tilt
Time frame: 2 years
Assessing the migration pattern of the Continuum® Cup
Time frame: 2 years
Determining a correlation between radiolucent lines (RLLs) measured by Charnley-DeLee Zone Analyses and migration characteristics using RSA
Time frame: 2 years
Determine if inducible displacement is indicative of adequate fixation
Time frame: 2 years
Assess the health status and functional outcome of patients with the Continuum® Cup
Time frame: 2 years
Assess the wear rate of the Vitamin E polyethylene with a ceramic femoral head
Time frame: 2 years
Determine if the wear rate of the Vitamin E liner is the same in-vivo as it is in simulation testing
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
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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.
Scott Sporer, MD principal investigator
Central DuPage Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RSA images in people with Radiostereometric Analysis and Vitamin E Liner, run by Central DuPage Hospital at 1 site 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 15 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: status not confirmed, as of the sponsor's last update on 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefanie Miller (630-933-6254, Stefanie.Miller@CadenceHealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the Continuum® Cup for adequate fixation to the underlying bone as measured by migration and tilt (time frame: 2 years). The study lists 7 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 24 Aug 2017.