OsteoarthritisNCT01165957
A Comparison of Wear Among Mobile and Fixed Bearing Knee Replacements
An observational study of Osteoarthritis, run by Anderson Orthopaedic Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to determine the amount of polyethylene wear associated with knee replacement designs that incorporate either a fixed or mobile bearing. Tibial polyethylene inserts retrieved from modular total knee replacements during revision operations will be analyzed by obtaining micro-CT images of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to May 2012
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Retrieved polyethylene tibial inserts archived as part the Anderson Orthopaedic Research Institute's implant retrieval program.
Who may be able to join
- DePuy mobile and fixed bearing polyethylene tibial inserts retrieved after at least 12 months in vivo.
- Inserts terminally sterilized by gas plasma or with gamma radiation in oxygen-free barrier packaging.
Who cannot join
- Inserts that were sterilized by gamma radiation and exposed to oxygen in packaging.
Trial locations and contacts
1 site in 1 country.
United States1 site
Anderson Orthopaedic Research Institute
Alexandria, Virginia, 22306
About this study
Official title: A Comparison of Volumetric Wear Among DePuy Mobile and Fixed Bearing Knee Tibial Inserts
The purpose of this study is to determine the amount of polyethylene wear associated with knee replacement designs that incorporate either a fixed or mobile bearing. Tibial polyethylene inserts retrieved from modular total knee replacements during revision operations will be analyzed by obtaining micro-CT images of the retrieved inserts. The components of total volumetric polyethylene loss, including wear associated with the medial articular, lateral articular and backside regions of the insert be quantified by comparing the worn insert with an unworn control. The investigators hypothesize that the fixed bearing inserts where the polyethylene is locked to the metal baseplate will demonstrate more volumetric wear than the mobile bearing inserts that are designed to slide or rotate on the metal baseplate.
Read the detailed description
Polyethylene wear is a major factor limiting the longevity of total knee arthroplasty. Evaluation of the volumetric wear of explanted polyethylene tibial inserts can provide valuable insight into the performance of different designs. Current technologies available to measure the volumetric wear of tibial inserts include gravimetric techniques, coordinate measuring machines (CMM), laser-scanning, and micro-CT.
In this study, we will employ micro-CT to determine volumetric wear because it allows us to obtain high-resolution three-dimensional images of the entire insert volume, including the surfaces as well as the interior of the insert. The micro-CT images will be used to reconstruct the entire three-dimensional geometry of the insert (including subsurface voids) and we will use image analysis software to partition the reconstructed insert into discrete regions (i.e. medial/lateral articulating surfaces, backside, and post), allowing us to determine how various regions contribute to total implant wear. By subdividing the insert into discrete regions, our analysis techniques will also enable us to account for material removed from the insert during explantation when evaluating implant wear. By comparing retrieved inserts with unworn controls using three-dimensional image analysis software, we will also quantify plastic deformation by measuring the volume of material that has deformed outside the confines of the control insert. Additionally, inspection of shape differences between the worn and unworn specimens will enable us to distinguish between implant wear, plastic deformation and volume differences associated with manufacturing tolerances. Although partial voluming effects can make edge detection challenging, high resolution micro-CT images tend to minimize these effects and we will use gravimetric measurements to determine an insert-specific Hounsfield threshold that will be used to define the image volume for each specimen. We will subsequently validate the accuracy of the reconstructed insert volume derived from the micro-CT image by comparing it with linear measurements from the actual specimen at several discrete locations.
The use of micro-CT scans to evaluate the in vivo volumetric wear associated with different designs will enable accurate measurement of volumetric polyethylene loss from different regions of the insert. This information will provide a better understanding of the clinical outcome associated with different design strategies and provide data to guide future development efforts. We hypothesize that fixed bearing inserts, where the polyethylene is locked to the metal baseplate, will demonstrate more volumetric wear than the mobile bearing inserts that are designed to slide or rotate on the metal baseplate.
Articular side wear will be measured by registering micro-CT images from retrieved and control inserts on unworn portions of the articular surface using the Analyze image analysis software (Mayo Biomedical Imaging Resource, Rochester, MN). Differences in volume among the retrieved and unworn control inserts will be evaluated accounting for plastic deformation that may occur in vivo. Volumetric wear for the entire insert and subregions will be calculated by subtracting the volume of plastic deformation (corresponding to regions of the retrieved insert outside the boundaries of the control insert) from the volume of material lost within the confines of the original insert geometry. We will compare wear among the mobile and fixed bearings using an Independent Sample t-test or Mann-Whitney U, depending on the distribution of the data. We will also use multiple linear regression analysis to examine the relationship between insert wear and other variables, including time in vivo, terminal sterilization technique for the insert and patient-related factors such as gender, age, and body mass index (BMI).
- Conditions
- Osteoarthritis
- Keywords
- Knee replacement, Mobile and fixed bearings, Volumetric wear, Micro-CT analysis, Articular and backside wear
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mobile bearings | Tibial polyethylene inserts retrieved from total knee replacements where the insert is designed to slide or rotate on the metal baseplate. | |
| Fixed bearings | Tibial polyethylene inserts retrieved from total knee replacements where the insert is locked to the metal baseplate. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Volumetric Wear
Total volumetric polyethylene wear will be measured among mobile and fixed bearing tibial inserts retrieved during a revision surgery.
Measured: At time of revision (average 46 months)
Secondary outcomes (1)
Local Volumetric Wear
Wear from different regions, including the medial articular, lateral articular and backside surfaces, will be evaluated. Maximum linear penetration will also be determined for the medial and lateral compartments.
Measured: At time of revision (average 46 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anderson Orthopaedic Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Orthopaedics
- Responsible party
- Principal investigator, C. Anderson Engh, Jr., MD, Anderson Orthopaedic Research Institute
- Investigators
- Robert H Hopper, Jr., PhD, Study director, Anderson Orthopaedic Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01165957
- Sponsor's protocol ID
- AORI2010-0102
- Other IDs
- Study #09010
- Status last verified
- Jul 2012
- First submitted
- 13 Jul 2010
- Last updated
- 1 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
McEwen HM, Barnett PI, Bell CJ, Farrar R, Auger DD, Stone MH, Fisher J. The influence of design, materials and kinematics on the in vitro wear of total knee replacements. J Biomech. 2005 Feb;38(2):357-65. doi: 10.1016/j.jbiomech.2004.02.015.
PubMed 15598464Jennings LM, Bell CI, Ingham E, Komistek RD, Stone MH, Fisher J. The influence of femoral condylar lift-off on the wear of artificial knee joints. Proc Inst Mech Eng H. 2007 Apr;221(3):305-14. doi: 10.1243/09544119JEIM215.
PubMed 17539585
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Volumetric Wear Among DePuy Mobile and Fixed Bearing Knee Tibial Inserts
- ClinicalTrials.gov ID
- NCT01165957
- Acronym / sponsor ID
- AORI2010-0102
- Conditions
- Osteoarthritis
- Keywords
- Knee replacement, Mobile and fixed bearings, Volumetric wear, Micro-CT analysis, Articular and backside wear
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Anderson Orthopaedic Research InstituteUniversity, hospital or other
- Collaborators
- DePuy Orthopaedics
- Study start
- Jun 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 20 Jul 2010 (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 determine the amount of polyethylene wear associated with knee replacement designs that incorporate either a fixed or mobile bearing. Tibial polyethylene inserts retrieved from modular total knee replacements during revision operations will be analyzed by obtaining micro-CT images of the retrieved inserts. The components of total volumetric polyethylene loss, including wear associated with the medial articular, lateral articular and backside regions of the insert be quantified by comparing the worn insert with an unworn control. The investigators hypothesize that the fixed bearing inserts where the polyethylene is locked to the metal baseplate will demonstrate more volumetric wear than the mobile bearing inserts that are designed to slide or rotate on the metal baseplate.
Detailed description
Polyethylene wear is a major factor limiting the longevity of total knee arthroplasty. Evaluation of the volumetric wear of explanted polyethylene tibial inserts can provide valuable insight into the performance of different designs. Current technologies available to measure the volumetric wear of tibial inserts include gravimetric techniques, coordinate measuring machines (CMM), laser-scanning, and micro-CT.
In this study, we will employ micro-CT to determine volumetric wear because it allows us to obtain high-resolution three-dimensional images of the entire insert volume, including the surfaces as well as the interior of the insert. The micro-CT images will be used to reconstruct the entire three-dimensional geometry of the insert (including subsurface voids) and we will use image analysis software to partition the reconstructed insert into discrete regions (i.e. medial/lateral articulating surfaces, backside, and post), allowing us to determine how various regions contribute to total implant wear. By subdividing the insert into discrete regions, our analysis techniques will also enable us to account for material removed from the insert during explantation when evaluating implant wear. By comparing retrieved inserts with unworn controls using three-dimensional image analysis software, we will also quantify plastic deformation by measuring the volume of material that has deformed outside the confines of the control insert. Additionally, inspection of shape differences between the worn and unworn specimens will enable us to distinguish between implant wear, plastic deformation and volume differences associated with manufacturing tolerances. Although partial voluming effects can make edge detection challenging, high resolution micro-CT images tend to minimize these effects and we will use gravimetric measurements to determine an insert-specific Hounsfield threshold that will be used to define the image volume for each specimen. We will subsequently validate the accuracy of the reconstructed insert volume derived from the micro-CT image by comparing it with linear measurements from the actual specimen at several discrete locations.
The use of micro-CT scans to evaluate the in vivo volumetric wear associated with different designs will enable accurate measurement of volumetric polyethylene loss from different regions of the insert. This information will provide a better understanding of the clinical outcome associated with different design strategies and provide data to guide future development efforts. We hypothesize that fixed bearing inserts, where the polyethylene is locked to the metal baseplate, will demonstrate more volumetric wear than the mobile bearing inserts that are designed to slide or rotate on the metal baseplate.
Articular side wear will be measured by registering micro-CT images from retrieved and control inserts on unworn portions of the articular surface using the Analyze image analysis software (Mayo Biomedical Imaging Resource, Rochester, MN). Differences in volume among the retrieved and unworn control inserts will be evaluated accounting for plastic deformation that may occur in vivo. Volumetric wear for the entire insert and subregions will be calculated by subtracting the volume of plastic deformation (corresponding to regions of the retrieved insert outside the boundaries of the control insert) from the volume of material lost within the confines of the original insert geometry. We will compare wear among the mobile and fixed bearings using an Independent Sample t-test or Mann-Whitney U, depending on the distribution of the data. We will also use multiple linear regression analysis to examine the relationship between insert wear and other variables, including time in vivo, terminal sterilization technique for the insert and patient-related factors such as gender, age, and body mass index (BMI).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile bearings | – | –Tibial polyethylene inserts retrieved from total knee replacements where the insert is designed to slide or rotate on the metal baseplate. |
| Fixed bearings | – | –Tibial polyethylene inserts retrieved from total knee replacements where the insert is locked to the metal baseplate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrieved polyethylene tibial inserts archived as part the Anderson Orthopaedic Research Institute's implant retrieval program.
Key inclusion criteria (2 listed)
- DePuy mobile and fixed bearing polyethylene tibial inserts retrieved after at least 12 months in vivo.
- Inserts terminally sterilized by gas plasma or with gamma radiation in oxygen-free barrier packaging.
Key exclusion criteria (1 listed)
- Inserts that were sterilized by gamma radiation and exposed to oxygen in packaging.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total Volumetric Wear
Time frame: At time of revision (average 46 months)
Total volumetric polyethylene wear will be measured among mobile and fixed bearing tibial inserts retrieved during a revision surgery.
1 secondary outcome
Local Volumetric Wear
Time frame: At time of revision (average 46 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2012.
- Background: PubMed 15598464McEwen HM, Barnett PI, Bell CJ, Farrar R, Auger DD, Stone MH, Fisher J. The influence of design, materials and kinematics on the in vitro wear of total knee replacements. J Biomech. 2005 Feb;38(2):357-65. doi: 10.1016/j.jbiomech.2004.02.015.
- Background: PubMed 17539585Jennings LM, Bell CI, Ingham E, Komistek RD, Stone MH, Fisher J. The influence of femoral condylar lift-off on the wear of artificial knee joints. Proc Inst Mech Eng H. 2007 Apr;221(3):305-14. doi: 10.1243/09544119JEIM215.
- Website for Anderson Orthopaedic Research InstituteLink provided by the sponsor.
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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.
Robert H Hopper, Jr., PhD study director
Anderson Orthopaedic Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by Anderson Orthopaedic Research Institute 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 2 inclusion and 1 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 1 Aug 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total Volumetric Wear (time frame: At time of revision (average 46 months)). 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 NCT01165957, which also lists 2 linked publications.
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 Aug 2012.