OsteoarthritisNCT00492219
Postoperative Function Following Partial and Total Knee Replacement
A study testing Vanguard M fixed-bearing or Oxford mobile-bearing prostheses and Total Knee Replacement in people with Osteoarthritis and Post-traumatic Arthritis, run by New Lexington Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine if patients with a fixed-bearing or mobile-bearing partial knee replacement perform functional activities differently than patients that have had total knee replacement or healthy volunteers that have not had knee surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Post-traumatic Arthritis
- What is being tested?
- Vanguard M fixed-bearing or Oxford mobile-bearing prostheses and Total Knee Replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Dec 2007
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients that have elected to undergo either partial or total knee replacement, as well as a control group of patients free of lower extremity pathology
Who cannot join
- Sensory, neurological, or general health conditions that alter perception of the patient's limb in space
- Vestibular disorders will be excluded in order to protect against falls during functional testing
- Unable to understand the questions used to obtain the Knee Society Score
- Minors and prisoners will be excluded from the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Lexington Clinic Sports Medicine Center
Lexington, Kentucky, 40504
About this study
The purpose of this study is to determine if patients with a fixed-bearing or mobile-bearing partial knee replacement perform functional activities differently than patients that have had total knee replacement or healthy volunteers that have not had knee surgery. The activities we are interested in include getting up out of a chair, stepping up and over a small wooden box, and standing still with the knees straight and also bent to 45 degrees.
Read the detailed description
Patients will be asked for a brief medical history so that we may determine if he/she can participate in the study. If the patient is going to have partial knee replacement, he/she will be randomly assigned to receive either a fixed-bearing (Vanguard M, Biomet, Warsaw, IN) or mobile-bearing (Oxford, Biomet, Warsaw, IN) partial knee replacement. Both implant systems are FDA approved and Dr. Christensen is equally skilled with both systems. The fixed-bearing partial knee replacement is made up of a polished metal piece that is cemented to the femur and a metal piece that is cemented to the tibia. The plastic portion of the fixed-bearing partial knee replacement is attached to the tibial metal tray and does not move. The mobile-bearing knee replacement also has a metal pieces cemented to the femur and tibia, but between the two metal pieces is a small plastic piece that moves as the knee bends and straightens. Patients will have an equal opportunity of receiving either implant system.
If the patient is having total knee replacement, the surgery will be the same as if he/she did not participate in the study, except that we will collect information from the patient during office visits and will ask the patient to perform the functional tests. If the participant is one of the healthy volunteers, he/she will not have knee surgery and will only be asked to perform the functional tests.
Information collected during office visits:
A member of our research team will ask the patient a series of questions about the knee. Patients will be asked to answer this series of questions a total of 4 times over the course of 1 year. Also, we will record how well the patient can bend and straighten the knee at these 4 office visits. We will have patients rate the pain in their knee and ask if they are satisfied with the surgery. If patients have any complications, those will also be recorded. Patients will have X-rays taken of your knee at your follow-up visits. This is the normal routine following knee replacement. The X-rays will be read by the surgeon to help determine the success of the surgery.
We will also ask patients to perform 3 functional tests at each of these office visits. These 3 tests will be performed on a raised platform that is approximately 2 inches above the floor. For the first test, the patient will be asked to stand still with knees straight for two seconds, and then be asked to stand still with knees bent to 45 degrees for two seconds. For the second test, the patient will be asked to stand up from a seated position. For the third test, the patient will be asked to step up onto a four-inch wooden box and then step back down onto the platform. Prior to testing, the patient will be allowed to practice each of these tests as many times as necessary until he/she feels comfortable. During testing, an investigator will help make sure that the patient is able to safely and properly perform 3 repetitions of each test. We will not ask patients to perform one or more of the functional tests if they are unable to perform the test without constant use of their arms for support.
- Conditions
- Osteoarthritis, Post-traumatic Arthritis
- Being tested
- Vanguard M fixed-bearing or Oxford mobile-bearing prostheses, Total Knee Replacement
- Keywords
- arthroplasty, replacement, knee, prosthesis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vanguard M fixed-bearing or Oxford mobile-bearing prosthesesDevice
Also called All implant systems associated with this study are manufactured by Biomet, Inc. in Warsaw, IN.
Patients that are appropriate for partial knee replacement will be randomized to receive one of these two FDA-approved implant systems.
Total Knee ReplacementDevice
Also called All implant systems associated with this study are manufactured by Biomet, Inc. in Warsaw, IN.
Patients undergoing total knee replacement with the Vanguard Complete Knee implant system
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Patients undergoing total knee replacement Receives: Device: Total Knee Replacement |
| 2 | No intervention | Healthy volunteers that are not undergoing knee replacement surgery |
| 3 | Experimental | Patients undergoing partial knee replacement with the Oxford mobile bearing implant system Receives: Device: Vanguard M fixed-bearing or Oxford mobile-bearing prostheses |
| 4 | Experimental | Patients undergoing partial knee replacement with the Vanguard M implant system Receives: Device: Vanguard M fixed-bearing or Oxford mobile-bearing prostheses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of three functional tests on a force platform
Measured: Baseline (preoperative), 6 weeks, 3 months, and 1, 2, and 5 years postoperative
Knee Society Scores
Measured: Baseline (preoperative), and 6 weeks, 3 months, and 1, 2, and 5 years after surgery
Patient Satisfaction
Measured: 6 weeks, 3 months, and 1, 2, and 5 years after surgery
Any postoperative complications
Measured: 6 weeks, 3 months, and 1, 2, and 5 years after surgery
Radiographic signs of component loosening or change of position, as well as progression of arthritis in the lateral compartment for the partial knee replacement patients
Measured: 6 weeks and 1, 2, and 5 years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2007 (estimated)
- Study startOct 2006
- Primary completionDec 2007
- Study completionDec 2007
Why it stopped: No longer have access to equipment used for functional data collection
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New Lexington Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
- Investigators
- Christian P Christensen, MD, Principal investigator, New Lexington Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00492219
- Sponsor's protocol ID
- LCO.2006.05
- Status last verified
- Jun 2007
- First submitted
- 25 Jun 2007
- Last updated
- 19 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Berend KR, Lombardi AV Jr. Liberal indications for minimally invasive oxford unicondylar arthroplasty provide rapid functional recovery and pain relief. Surg Technol Int. 2007;16:193-7.
PubMed 17429788Li MG, Yao F, Joss B, Ioppolo J, Nivbrant B, Wood D. Mobile vs. fixed bearing unicondylar knee arthroplasty: A randomized study on short term clinical outcomes and knee kinematics. Knee. 2006 Oct;13(5):365-70. doi: 10.1016/j.knee.2006.05.003. Epub 2006 Jun 22.
PubMed 16797994
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Function Following Partial and Total Knee Replacement
- ClinicalTrials.gov ID
- NCT00492219
- Acronym / sponsor ID
- LCO.2006.05
- Conditions
- Osteoarthritis, Post-traumatic Arthritis
- Keywords
- arthroplasty, replacement, knee, prosthesis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No longer have access to equipment used for functional data collection
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- New Lexington ClinicUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- Oct 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 27 Jun 2007 (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 if patients with a fixed-bearing or mobile-bearing partial knee replacement perform functional activities differently than patients that have had total knee replacement or healthy volunteers that have not had knee surgery. The activities we are interested in include getting up out of a chair, stepping up and over a small wooden box, and standing still with the knees straight and also bent to 45 degrees.
Detailed description
Patients will be asked for a brief medical history so that we may determine if he/she can participate in the study. If the patient is going to have partial knee replacement, he/she will be randomly assigned to receive either a fixed-bearing (Vanguard M, Biomet, Warsaw, IN) or mobile-bearing (Oxford, Biomet, Warsaw, IN) partial knee replacement. Both implant systems are FDA approved and Dr. Christensen is equally skilled with both systems. The fixed-bearing partial knee replacement is made up of a polished metal piece that is cemented to the femur and a metal piece that is cemented to the tibia. The plastic portion of the fixed-bearing partial knee replacement is attached to the tibial metal tray and does not move. The mobile-bearing knee replacement also has a metal pieces cemented to the femur and tibia, but between the two metal pieces is a small plastic piece that moves as the knee bends and straightens. Patients will have an equal opportunity of receiving either implant system.
If the patient is having total knee replacement, the surgery will be the same as if he/she did not participate in the study, except that we will collect information from the patient during office visits and will ask the patient to perform the functional tests. If the participant is one of the healthy volunteers, he/she will not have knee surgery and will only be asked to perform the functional tests.
Information collected during office visits:
A member of our research team will ask the patient a series of questions about the knee. Patients will be asked to answer this series of questions a total of 4 times over the course of 1 year. Also, we will record how well the patient can bend and straighten the knee at these 4 office visits. We will have patients rate the pain in their knee and ask if they are satisfied with the surgery. If patients have any complications, those will also be recorded. Patients will have X-rays taken of your knee at your follow-up visits. This is the normal routine following knee replacement. The X-rays will be read by the surgeon to help determine the success of the surgery.
We will also ask patients to perform 3 functional tests at each of these office visits. These 3 tests will be performed on a raised platform that is approximately 2 inches above the floor. For the first test, the patient will be asked to stand still with knees straight for two seconds, and then be asked to stand still with knees bent to 45 degrees for two seconds. For the second test, the patient will be asked to stand up from a seated position. For the third test, the patient will be asked to step up onto a four-inch wooden box and then step back down onto the platform. Prior to testing, the patient will be allowed to practice each of these tests as many times as necessary until he/she feels comfortable. During testing, an investigator will help make sure that the patient is able to safely and properly perform 3 repetitions of each test. We will not ask patients to perform one or more of the functional tests if they are unable to perform the test without constant use of their arms for support.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Total Knee ReplacementPatients undergoing total knee replacement |
| 2 | No intervention | –Healthy volunteers that are not undergoing knee replacement surgery |
| 3 | Experimental | Device: Vanguard M fixed-bearing or Oxford mobile-bearing prosthesesPatients undergoing partial knee replacement with the Oxford mobile bearing implant system |
| 4 | Experimental | Device: Vanguard M fixed-bearing or Oxford mobile-bearing prosthesesPatients undergoing partial knee replacement with the Vanguard M implant system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients that have elected to undergo either partial or total knee replacement, as well as a control group of patients free of lower extremity pathology
Key exclusion criteria (4 listed)
- Sensory, neurological, or general health conditions that alter perception of the patient's limb in space
- Vestibular disorders will be excluded in order to protect against falls during functional testing
- Unable to understand the questions used to obtain the Knee Society Score
- Minors and prisoners will be excluded from the study
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 |
|---|---|---|
| Vanguard M fixed-bearing or Oxford mobile-bearing prosthesesAlso: All implant systems associated with this study are manufactured by Biomet, Inc. in Warsaw, IN.Patients that are appropriate for partial knee replacement will be randomized to receive one of these two FDA-approved implant systems. | Device | 3, 4 |
| Total Knee ReplacementAlso: All implant systems associated with this study are manufactured by Biomet, Inc. in Warsaw, IN.Patients undergoing total knee replacement with the Vanguard Complete Knee implant system | Device | 1 |
Primary outcome
Performance of three functional tests on a force platform
Time frame: Baseline (preoperative), 6 weeks, 3 months, and 1, 2, and 5 years postoperative
Knee Society Scores
Time frame: Baseline (preoperative), and 6 weeks, 3 months, and 1, 2, and 5 years after surgery
Patient Satisfaction
Time frame: 6 weeks, 3 months, and 1, 2, and 5 years after surgery
Any postoperative complications
Time frame: 6 weeks, 3 months, and 1, 2, and 5 years after surgery
Radiographic signs of component loosening or change of position, as well as progression of arthritis in the lateral compartment for the partial knee replacement patients
Time frame: 6 weeks and 1, 2, and 5 years postoperative
Results and safety
The study was stopped early (reason given: No longer have access to equipment used for functional data collection). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2012.
- Background: PubMed 17429788Berend KR, Lombardi AV Jr. Liberal indications for minimally invasive oxford unicondylar arthroplasty provide rapid functional recovery and pain relief. Surg Technol Int. 2007;16:193-7.
- Background: PubMed 16797994Li MG, Yao F, Joss B, Ioppolo J, Nivbrant B, Wood D. Mobile vs. fixed bearing unicondylar knee arthroplasty: A randomized study on short term clinical outcomes and knee kinematics. Knee. 2006 Oct;13(5):365-70. doi: 10.1016/j.knee.2006.05.003. Epub 2006 Jun 22.
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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.
Christian P Christensen, MD principal investigator
New Lexington Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vanguard M fixed-bearing or Oxford mobile-bearing prostheses and Total Knee Replacement in people with Osteoarthritis and Post-traumatic Arthritis, run by New Lexington Clinic 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 1 inclusion and 4 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 19 Oct 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 was stopped early (reason given: No longer have access to equipment used for functional data collection). Results are not available in the source record.
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?
Performance of three functional tests on a force platform (time frame: Baseline (preoperative), 6 weeks, 3 months, and 1, 2, and 5 years postoperative). The study lists 5 primary outcomes in all. 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 NCT00492219, 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 19 Oct 2012; AzTrials last refreshed its copy on 27 Oct 2026.