Total Knee ArthroplastyNCT00589147
A Prospective, Randomized, Controlled Study Comparing Three Tibial Component Designs in Total Knee Arthoplasty
A study testing The Zimmer NexGen Legacy Knee System, modular cemented tibia, The Zimmer NexGen Legacy Knee System, non-modular cemented tibia. and The Zimmer NexGen Legacy Knee System, non-modular uncemented tibia in people with Total Knee Arthroplasty, run by Mayo Clinic at 1 site in United States.
Trial summary
SUMMARY A prospective, randomized, single-blinded clinical trial is proposed to compare three tibial tray designs for patients undergoing total knee arthroplasty. This study is designed to address the clinically important issues of tibial component modularity and fixation in total knee replacement. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- The Zimmer NexGen Legacy Knee System, modular cemented tibia, The Zimmer NexGen Legacy Knee System, non-modular cemented tibia. and The Zimmer NexGen Legacy Knee System, non-modular uncemented tibia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 397 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Jun 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients greater then or equal to 20 and less then or equal to 85 undergoing unilateral primary knee surgery for degenerative joint disease (DJD).
Who cannot join
- Age less than 20 years or > 85.
- Severe deformity great then or equal to 20 degrees varus, valgus malalignment or flexion deformity.
- Osteomyelitis, septicemia, prior infection of knee joint, 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, and hepatitis.
- Significant neurological or musculoskeletal disorders or disease that may adversely affect normal gait or weight bearing.
- Metastatic disease.
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- Any congenital, developmental, or other bone disease or previous knee surgery that may, in the surgeon's judgement, interfere with TK prosthesis survival or success, e.g. Paget's disease, Charcot's disease secondary to diabetes, severe osteoporosis, previous high tibial osteotomy, etc.
- 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
SUMMARY A prospective, randomized, single-blinded clinical trial is proposed to compare three tibial tray designs for patients undergoing total knee arthroplasty. This study is designed to address the clinically important issues of tibial component modularity and fixation in total knee replacement. The Zimmer NexGen Legacy knee system is an FDA approved device and in this study will be used with 1) a modular tibial tray inserted with cement and 2) a non-modular tibial tray inserted with cement, and 3) a non-modular tibial tray inserted without cement. The insertion of total knee components without cement has been done clinically for over 20 years but has not been specifically approved by the FDA. Thus treatment arm 3, a non-modular tray inserted without cement, would involve the so-called off-label use of the device.
136 cases will be assigned to each arm of the study. Each patient will be assessed two months after surgery, one year after surgery, two years after surgery, five years after surgery, and every three to five years thereafter. The principal outcome measures will be the Knee Society Clinical rating scale, the SF-36 and the presence of significant lucent lines.. These measures will be compared among patients in the 3 trial arms at 5 years post surgery (or at the last follow-up point for those who drop out or become lost to follow-up). The Knee Society scores and SF-36 scores will be analyzed using analysis of variance models Rates of significant lucencies, perioperative mortality, as well as complications such as deep vein thrombosis, pulmonary embolus, neurovascular complication, and infection will be compared among the groups using chi-square tests . Rates of revision surgery will be compared among the groups using survivorship methods.
PURPOSE The primary aim of the study is to compare the results obtained with each of three tibial designs for patients undergoing total knee arthroplasty. Those results will be measured with disease-specific (Knee Society Scores), global (SF-36), and outcome measures. Radiographic results consisting of standing alignment, lateral and skyline views of the surgical knee will be recorded and analyzed. Completion of the intial investigation will occur at the 5-year interval after the last enrolled patient.
- Conditions
- Total Knee Arthroplasty
- Being tested
- The Zimmer NexGen Legacy Knee System, modular cemented tibia, The Zimmer NexGen Legacy Knee System, non-modular cemented tibia., The Zimmer NexGen Legacy Knee System, non-modular uncemented tibia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Zimmer NexGen Legacy Knee System, modular cemented tibiaDevice
modular cemented tibia
The Zimmer NexGen Legacy Knee System, non-modular cemented tibia.Device
non-modular cemented tibia.
The Zimmer NexGen Legacy Knee System, non-modular uncemented tibiaDevice
non-modular uncemented tibia
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | One study group will consist of patients treated with the modular cemented tibia. Receives: Device: The Zimmer NexGen Legacy Knee System, modular cemented tibia |
| 2 | Active comparator | Study arm will consist of patients that are treated with non-modular cemented tibia. Receives: Device: The Zimmer NexGen Legacy Knee System, non-modular cemented tibia. |
| 3 | Active comparator | Study arm will consist of patients that are treated with non-modular uncemented tibia. Receives: Device: The Zimmer NexGen Legacy Knee System, non-modular uncemented tibia |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary aim of the study is to compare the results obtained with each of 3 tibial designs for patients undergoing TKA. Those results will be measured with disease-specific (Knee Society Scores), global (SF-36), and outcome measures.
Measured: 2 months, 1 year, 2 years, and 5 years
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 startAug 2003
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies 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
- 397 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
- Investigators
- Mark W. Pagnano, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00589147
- Sponsor's protocol ID
- 2320-02
- Status last verified
- May 2012
- First submitted
- 21 Dec 2007
- Last updated
- 28 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Study Comparing Three Tibial Component Designs in Total Knee Arthoplasty
- ClinicalTrials.gov ID
- NCT00589147
- Acronym / sponsor ID
- 2320-02
- Conditions
- Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 397 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- Aug 2003
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 9 Jan 2008 (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.
SUMMARY A prospective, randomized, single-blinded clinical trial is proposed to compare three tibial tray designs for patients undergoing total knee arthroplasty. This study is designed to address the clinically important issues of tibial component modularity and fixation in total knee replacement. The Zimmer NexGen Legacy knee system is an FDA approved device and in this study will be used with 1) a modular tibial tray inserted with cement and 2) a non-modular tibial tray inserted with cement, and 3) a non-modular tibial tray inserted without cement. The insertion of total knee components without cement has been done clinically for over 20 years but has not been specifically approved by the FDA. Thus treatment arm 3, a non-modular tray inserted without cement, would involve the so-called off-label use of the device.
136 cases will be assigned to each arm of the study. Each patient will be assessed two months after surgery, one year after surgery, two years after surgery, five years after surgery, and every three to five years thereafter. The principal outcome measures will be the Knee Society Clinical rating scale, the SF-36 and the presence of significant lucent lines.. These measures will be compared among patients in the 3 trial arms at 5 years post surgery (or at the last follow-up point for those who drop out or become lost to follow-up). The Knee Society scores and SF-36 scores will be analyzed using analysis of variance models Rates of significant lucencies, perioperative mortality, as well as complications such as deep vein thrombosis, pulmonary embolus, neurovascular complication, and infection will be compared among the groups using chi-square tests . Rates of revision surgery will be compared among the groups using survivorship methods.
PURPOSE The primary aim of the study is to compare the results obtained with each of three tibial designs for patients undergoing total knee arthroplasty. Those results will be measured with disease-specific (Knee Society Scores), global (SF-36), and outcome measures. Radiographic results consisting of standing alignment, lateral and skyline views of the surgical knee will be recorded and analyzed. Completion of the intial investigation will occur at the 5-year interval after the last enrolled patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: The Zimmer NexGen Legacy Knee System, modular cemented tibiaOne study group will consist of patients treated with the modular cemented tibia. |
| 2 | Active comparator | Device: The Zimmer NexGen Legacy Knee System, non-modular cemented tibia.Study arm will consist of patients that are treated with non-modular cemented tibia. |
| 3 | Active comparator | Device: The Zimmer NexGen Legacy Knee System, non-modular uncemented tibiaStudy arm will consist of patients that are treated with non-modular uncemented tibia. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients greater then or equal to 20 and less then or equal to 85 undergoing unilateral primary knee surgery for degenerative joint disease (DJD).
Key exclusion criteria (10 listed)
- Age less than 20 years or > 85.
- Severe deformity great then or equal to 20 degrees varus, valgus malalignment or flexion deformity.
- Osteomyelitis, septicemia, prior infection of knee joint, 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, and hepatitis.
- Significant neurological or musculoskeletal disorders or disease that may adversely affect normal gait or weight bearing.
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 |
|---|---|---|
| The Zimmer NexGen Legacy Knee System, modular cemented tibiamodular cemented tibia | Device | 1 |
| The Zimmer NexGen Legacy Knee System, non-modular cemented tibia.non-modular cemented tibia. | Device | 2 |
| The Zimmer NexGen Legacy Knee System, non-modular uncemented tibianon-modular uncemented tibia | Device | 3 |
Primary outcome
The primary aim of the study is to compare the results obtained with each of 3 tibial designs for patients undergoing TKA. Those results will be measured with disease-specific (Knee Society Scores), global (SF-36), and outcome measures.
Time frame: 2 months, 1 year, 2 years, and 5 years
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 28 May 2012.
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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.
Mark W. Pagnano, 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 The Zimmer NexGen Legacy Knee System, modular cemented tibia, The Zimmer NexGen Legacy Knee System, non-modular cemented tibia. and The Zimmer NexGen Legacy Knee System, non-modular uncemented tibia in people with Total Knee Arthroplasty, 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 10 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 28 May 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?
The primary aim of the study is to compare the results obtained with each of 3 tibial designs for patients undergoing TKA. Those results will be measured with disease-specific (Knee Society Scores), global (SF-36), and outcome measures. (time frame: 2 months, 1 year, 2 years, and 5 years). 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 28 May 2012.