Degenerative Joint DiseaseNCT00589108
Comparison of A Mobile-Bearing Total Knee System With A Fixed-Bearing Total Knee System In Cemented Total Knee Arthroplasty
A study testing Sigma Knee System, Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray and Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray in people with Degenerative Joint Disease, run by Mayo Clinic at 1 site in United States.
Trial summary
Pain, weakness, instability, and progressive dysfunction are the hallmarks of arthritis of the knee. Total knee replacement may frequently be the only therapeutic intervention to provide adequate improvement in pain and function. Both fixed bearing and mobile bearing knees have a long track record of clinical success. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Degenerative Joint Disease
- What is being tested?
- Sigma Knee System, Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray and Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2001to May 2011
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing unilateral primary knee surgery for degenerative joint disease (DJD).
Who cannot join
- Severe deformity greater than or equal to 20 degrees varus, valgus malalignment
- Osteomyelitis, septicemia, or other active infections that may spread to other areas of the body
- The presence of infections, highly communicable diseases, e.g., AIDS, active tuberculosis, venereal disease, hepatitis
- Significant neurological or musculoskeletal disorders or disease that may adversely affect normal gait or weight bearing
- Metastatic disease
- Any congenital, developmental, or other bone disease or previous knee surgery that may, in the surgeon's judgement, interfere with total knee prosthesis survival or success, e.g., Paget's disease, Charcot's disease secondary to diabetes, severe osteoporosis, previous high tibial osteotomy, etc.
Show all 9Show fewer
- Presence of previous prosthetic knee replacement device (any type)
- Arthrodesis of the affected knee
- Patients not requiring patella resurfacing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Controlled Study Comparing A Mobile-Bearing Total Knee System With A Fixed-Bearing Total Knee System In Cemented Total Knee Arthroplasty
Pain, weakness, instability, and progressive dysfunction are the hallmarks of arthritis of the knee. Total knee replacement may frequently be the only therapeutic intervention to provide adequate improvement in pain and function. Both fixed bearing and mobile bearing knees have a long track record of clinical success. Mobile bearing designs have theoretical advantages of decreased contact stresses on the tibial tray, decreased polyethylene wear, and improved range of motion relative to fixed bearing designs. These theoretical advantages may become especially important in the young patient who requires a knee arthroplasty. This study will attempt to see if there is a clinical difference in outcome between mobile bearing and fixed bearing knee arthroplasties in patients who require total knee replacement.
Read the detailed description
This prospective, randomized, single-blinded clinical trial compared a mobile-bearing total knee system with two types of fixed-bearing total knee systems in patients undergoing cemented total knee arthroplasty. The devices to be used are FDA approved: the Sigma Knee System (mobile-bearing), the Sigma, Pressfit Condylar posterior cruciate substituting (fixed-bearing) system with a metal backed tibial tray, and the Sigma press-fit condylar posterior cruciate substituting system (fixed bearing) with an all polyethylene tibial tray.
The surgical procedures were performed by 4 experienced orthopedic surgeons with a subspecialty interest in total knee arthroplasty. A midline skin incision and medial parapatellar arthrotomy were used to expose the knee. The distal femoral resection was performed with an intramedullary alignment guide, and the proximal tibial resection was performed with an extramedullary alignment guide. Knees with fixed deformities had a surgical release of the contracted tissues on the medial or lateral side, as appropriate, to obtain symmetric balance of the total knee replacement in both flexion and extension. The flexion and extension gaps and the medial and lateral soft-tissue structures were balanced in accordance with standard techniques.
Patients began progressive weight-bearing on the first postoperative day, and active knee range of motion was initiated with 24 hours after surgery. Patients were typically discharged on the fourth or fifth postoperative day after obtaining the ability to walk with a walker, to ascend several stairs, and to flex the knee 290 degrees. Patients were asked to return for examination and radiographs at 3 months, 1 year, 2 years, and 5 years after surgery.
- Conditions
- Degenerative Joint Disease
- Being tested
- Sigma Knee System, Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray, Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
- Keywords
- knee arthroplasty
- Medical subject headings
- Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sigma Knee SystemDevice
Also called Sigma Rotating Platform Knee System
Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial trayDevice
Also called Press-Fit Condylar Total Knee Arthroplasty
Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene trayDevice
Sigma Pressfit Condylar Posterior Cruciate Substituting System (fixed bearing with an all polyethylene tray)
| Study group | Role | What they receive |
|---|---|---|
| Mobile-Bearing Knee | Active comparator | Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert) Receives: Device: Sigma Knee System |
| Modular-Metal-Backed Knee | Active comparator | Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray) Receives: Device: Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray |
| All-Polyethylene Knee | Active comparator | Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray Receives: Device: Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Knee Flexion
The range of knee motion was measured clinically with use of a goniometer. Measurements were performed by physician assistants in the Department of Orthopedic Surgery who were blinded to the type of implant used. The subject was positioned supine on the examination table, and maximum active flexion was measured.
Measured: 2 years post-surgery, 5 years post-surgery
Secondary outcomes (4)
Knee Society Function Score
The Knee Society Function Score considers only walking distance and stair climbing, with deductions for walking aids. The maximum function score, which is 100, is obtained by a patient who can walk an unlimited distance and go up and down stairs normally. The minimum function score is 0.
Measured: 5 years post surgery
Knee Society Pain Score
The Knee Society Pain Score includes walking and climbing stairs. The maximum score per knee is 50 indicating no pain, and 0 indicates severe pain. Therefore the total score (for both knees) could range from 0 to 100.
Measured: 5 years post-surgery
Knee Society Stair Climbing Score
The stair-climbing portion of the Knee Society clinical rating system assigns a maximum score of 50 points for patients able to ascend and descend stairs in a normal fashion, 40 points for patients needing a rail to descend, 30 points for patients using a rail in both directions, 15 points for patients able to ascend but not descend at all, and 0 points for patients unable ascend or descend. Because stair ascent and descent put substantial demands on the patellofemoral joint, we used that portion of the Knee Society clinical rating system as a proxy for patellofemoral function in this study.
Measured: two years post-surgery, five years post-surgery
Percentage of Knees Surviving at 5 Years
Kaplan-Meier analysis of five-year implant survival rate
Measured: 5 years post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2008 (estimated)
- Study startJan 2001
- Primary completionMay 2011
- Study completionMay 2011
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Degenerative Joint DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert T. Trousdale, Mayo Clinic
- Investigators
- Robert T Trousdale, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00589108
- Sponsor's protocol ID
- 271-01
- Status last verified
- Dec 2012
- First submitted
- 21 Dec 2007
- Last updated
- 16 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kalisvaart MM, Pagnano MW, Trousdale RT, Stuart MJ, Hanssen AD. Randomized clinical trial of rotating-platform and fixed-bearing total knee arthroplasty: no clinically detectable differences at five years. J Bone Joint Surg Am. 2012 Mar 21;94(6):481-9. doi: 10.2106/JBJS.K.00315.
PubMed 22437996
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Study Comparing A Mobile-Bearing Total Knee System With A Fixed-Bearing Total Knee System In Cemented Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT00589108
- Acronym / sponsor ID
- 271-01
- Conditions
- Degenerative Joint Disease
- Keywords
- knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jan 2001
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 9 Jan 2008 (estimated)
- Results
- Posted 16 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pain, weakness, instability, and progressive dysfunction are the hallmarks of arthritis of the knee. Total knee replacement may frequently be the only therapeutic intervention to provide adequate improvement in pain and function. Both fixed bearing and mobile bearing knees have a long track record of clinical success. Mobile bearing designs have theoretical advantages of decreased contact stresses on the tibial tray, decreased polyethylene wear, and improved range of motion relative to fixed bearing designs. These theoretical advantages may become especially important in the young patient who requires a knee arthroplasty. This study will attempt to see if there is a clinical difference in outcome between mobile bearing and fixed bearing knee arthroplasties in patients who require total knee replacement.
Detailed description
This prospective, randomized, single-blinded clinical trial compared a mobile-bearing total knee system with two types of fixed-bearing total knee systems in patients undergoing cemented total knee arthroplasty. The devices to be used are FDA approved: the Sigma Knee System (mobile-bearing), the Sigma, Pressfit Condylar posterior cruciate substituting (fixed-bearing) system with a metal backed tibial tray, and the Sigma press-fit condylar posterior cruciate substituting system (fixed bearing) with an all polyethylene tibial tray.
The surgical procedures were performed by 4 experienced orthopedic surgeons with a subspecialty interest in total knee arthroplasty. A midline skin incision and medial parapatellar arthrotomy were used to expose the knee. The distal femoral resection was performed with an intramedullary alignment guide, and the proximal tibial resection was performed with an extramedullary alignment guide. Knees with fixed deformities had a surgical release of the contracted tissues on the medial or lateral side, as appropriate, to obtain symmetric balance of the total knee replacement in both flexion and extension. The flexion and extension gaps and the medial and lateral soft-tissue structures were balanced in accordance with standard techniques.
Patients began progressive weight-bearing on the first postoperative day, and active knee range of motion was initiated with 24 hours after surgery. Patients were typically discharged on the fourth or fifth postoperative day after obtaining the ability to walk with a walker, to ascend several stairs, and to flex the knee 290 degrees. Patients were asked to return for examination and radiographs at 3 months, 1 year, 2 years, and 5 years after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mobile-Bearing Knee | Active comparator | Device: Sigma Knee SystemSigma Knee System (mobile-bearing knee with the P.S. polyethylene insert) |
| Modular-Metal-Backed Knee | Active comparator | Device: Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial traySigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray) |
| All-Polyethylene Knee | Active comparator | Device: Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene traySigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing unilateral primary knee surgery for degenerative joint disease (DJD).
Key exclusion criteria (9 listed)
- Severe deformity greater than or equal to 20 degrees varus, valgus malalignment
- Osteomyelitis, septicemia, or other active infections that may spread to other areas of the body
- The presence of infections, highly communicable diseases, e.g., AIDS, active tuberculosis, venereal disease, hepatitis
- Significant neurological or musculoskeletal disorders or disease that may adversely affect normal gait or weight bearing
- Metastatic disease
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 |
|---|---|---|
| Sigma Knee SystemAlso: Sigma Rotating Platform Knee SystemSigma Knee System (mobile-bearing knee with the P.S. polyethylene insert) | Device | Mobile-Bearing Knee |
| Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial trayAlso: Press-Fit Condylar Total Knee ArthroplastySigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray) | Device | Modular-Metal-Backed Knee |
| Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene traySigma Pressfit Condylar Posterior Cruciate Substituting System (fixed bearing with an all polyethylene tray) | Device | All-Polyethylene Knee |
Primary outcome
Maximum Knee Flexion
Time frame: 2 years post-surgery, 5 years post-surgery
The range of knee motion was measured clinically with use of a goniometer. Measurements were performed by physician assistants in the Department of Orthopedic Surgery who were blinded to the type of implant used. The subject was positioned supine on the examination table, and maximum active flexion was measured.
4 secondary outcomes
Knee Society Function Score
Time frame: 5 years post surgery
Knee Society Pain Score
Time frame: 5 years post-surgery
Knee Society Stair Climbing Score
Time frame: two years post-surgery, five years post-surgery
Percentage of Knees Surviving at 5 Years
Time frame: 5 years post-surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22437996Kalisvaart MM, Pagnano MW, Trousdale RT, Stuart MJ, Hanssen AD. Randomized clinical trial of rotating-platform and fixed-bearing total knee arthroplasty: no clinically detectable differences at five years. J Bone Joint Surg Am. 2012 Mar 21;94(6):481-9. doi: 10.2106/JBJS.K.00315.
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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 T Trousdale, MD principal investigator
Mayo 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 Sigma Knee System, Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray and Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray in people with Degenerative Joint Disease, run by Mayo 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 9 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 16 Jan 2013. 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?
Yes. Results are posted in the registry (first posted 16 Jan 2013). 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?
Maximum Knee Flexion (time frame: 2 years post-surgery, 5 years post-surgery). 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 NCT00589108, which also lists 1 linked publication.
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 16 Jan 2013.