Arthroplasty, Replacement, KneeNCT00493792
X-3 Polyethylene Survival Outcomes Study
A study testing X3 Polyethylene and N2Vac Polyethylene in people with Arthroplasty, Replacement, Knee and Total Knee Replacement, run by Mayo Clinic at 3 sites in United States.
Trial summary
The goal of this clinical trial is to compare two types of polyethylene (Stryker Orthopaedics N2Vac and their X3 polyethylene) prostheses that are used in total knee replacements. The primary outcome will analyze whether or not prostheses require a revision surgery 10 years post knee replacement. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Arthroplasty, Replacement, Knee, Total Knee Replacement
- What is being tested?
- X3 Polyethylene and N2Vac Polyethylene
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 518 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2007to 1 Nov 2023
- 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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects willing to sign the informed consent.
- Subjects able to comply with follow-up requirements including post-operative weight bearing restrictions and self-evaluations.
- Male and non-pregnant female subjects ages 21-85 years of age at the time of surgery.
- Subjects requiring a primary total knee replacement.
- Subjects with a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
- Subjects with intact collateral ligaments as determined by the surgeon investigator.
Who cannot join
- Subjects with inflammatory arthritis.
- Subjects with a history of total or unicompartmental reconstruction of the affected joint.
- Subjects that have had a high tibial osteotomy or femoral osteotomy.
- Subjects with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
- Subjects with a systemic or metabolic disorder leading to progressive bone deterioration.
- Subjects that are immunologically compromised, or receiving chronic steroids (>30 days).
Show all 10Show fewer
- Subjects bone stock is compromised by disease or infection that cannot provide adequate support and/or fixation to the prosthesis.
- Subjects with knee fusion to the affected joint.
- Subjects with an active or suspected latent infection in or about the knee joint.
- Subjects that are prisoners.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mayo Clinic
Jacksonville, Florida, 32224
Mayo Clinic
Phoenix, Arizona, 85054
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: A Prospective, Randomized Study Comparing the Survival for X-3 Polyethylene to N2Vac Polyethylene When Used With the Triathlon Posterior Stabilized (PS) Total Knee System.
The goal of this clinical trial is to compare two types of polyethylene (Stryker Orthopaedics N2Vac and their X3 polyethylene) prostheses that are used in total knee replacements. The primary outcome will analyze whether or not prostheses require a revision surgery 10 years post knee replacement. Other outcomes such as reoperation rate, complications, radiographic results, and clinical outcomes will be collected.
It is hypothesized that X3 would perform equally well to N2Vac at 10 years.
Read the detailed description
This is a prospective, randomized and blinded clinical trial. Participants will be assessed pre-operatively and post-operatively at three months and two, five, seven and ten years. The primary aim of the study is to compare the survivorship of two types of polyethylene (conventional N2Vac and highly cross-linked X3, both FDA approved via 510k clearance) used in a fixed-bearing total knee system in patients undergoing cemented total knee arthroplasty. Specifically, the primary endpoint will be the revision rate at ten years. These results will be measured through radiographs at each post-operative interval with an independent radiograph review being performed after all patients have reached 7 and 10 year follow-up. Secondary results will also be collected and will focus on disease-specific (Knee Society Scores), global (SF-12), and outcome measures. Radiographic results consisting of standing anteroposterior, lateral and Merchant views of the surgical knee will be recorded and analyzed. Completion of the initial investigation will occur at the 10-year interval after the last enrolled patient.
- Being tested
- X3 Polyethylene, N2Vac Polyethylene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X3 PolyethyleneDevice
Also called X3
Highly cross-linked polyethylene (HXLPE).
N2Vac PolyethyleneDevice
Also called N2Vac
Ultra-high-molecular-weight polyethylene (UHMWPE).
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Stryker Orthopaedics N2Vac Polyethylene when used with a Triathlon Posterior Stabilized total knee system. This is a fixed- bearing knee intended for use in patients undergoing cemented total knee arthroplasty. Receives: Device: N2Vac Polyethylene |
| Treatment | Experimental | Stryker Orthopaedics X3 Polyethylene when used with a Triathlon Posterior Stabilized total knee system. This is a fixed- bearing knee intended for use in patients undergoing cemented total knee arthroplasty. Receives: Device: X3 Polyethylene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prosthesis Survivorship Free of Revision
The survival of prostheses free of revision 10 years post operation.
Measured: From operation to 10 years post-operative
Secondary outcomes (7)
Prosthesis Survivorship Free of Reoperation
The survival of prostheses free of reoperation 10 years post operation.
Measured: From operation to 10 years post-operative
Prosthesis Survivorship Free of Complications
The survival of prostheses free of related complications (non-operative) 10 years post operation.
Measured: From operation to 10 years post-operative
Knee Society Score (KSS)
The KSS evaluates pain, stability and range of motion. The scale ranges between scores of 0-100. The maximum score of 100 points is reached when there is no pain, with good alignment of the knee in extension, and at least 125° of range of motion, without any anteroposterior or mediolateral instability. Deductions are made for flexion contracture, loss of extension and poor alignment. Higher scores indicate better knee conditions, while lower scores indicate worse knee conditions.
Measured: Pre-operative (baseline) and 10-years post-operative
Knee Society Score (KSS): Function
The Function KSS evaluates the walking distance and the act of climbing and descending stairs. The scale ranges between 0-100. The maximum score of 100 points is attributed to the individual capable of walking unlimited distances without walking aids, and of climbing and descending stairs normally. Deductions are made for the use of canes, crutches or walking frame. Higher scores indicate better knee conditions, while lower scores indicate worse knee conditions.
Measured: Pre-operative (baseline) and 10-years post-operative
12-Item Short Form Health Survey (SF-12): Mental Health Score
The SF-12 questionnaire uses questions selected from the longer SF-36 Health Survey to measure patient wellness and quality of life. The scoring algorithm is calibrated so that an average healthy person would have a t-score of 50 points with a standard deviation of 10. Higher scores indicate better mental health.
Measured: Pre-operative (baseline) and 10-years post-operative
12-Item Short Form Health Survey (SF-12): Physical Health Score
The SF-12 questionnaire uses questions selected from the longer SF-36 Health Survey to measure patient wellness and quality of life. The scoring algorithm is calibrated so that an average healthy person would have a t-score of 50 points with a standard deviation of 10. Higher scores indicate better physical health.
Measured: Pre-operative (baseline) and 10-years post-operative
Comparison of Radiographic Success/Failure Between Groups
Radiographic review for success and or failure of the TKA prostheses at 10 years post-operation. A migrating or shifting prosthesis with or without the disappearance of radiolucent lines is considered a failure.
Measured: 10 years post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2007 (estimated)
- Study startFeb 2007
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
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.
- Other trials for Arthroplasty, Replacement, KneeStudies 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
- 518 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Orthopaedics
- Responsible party
- Principal investigator, Matthew P. Abdel, M.D., Mayo Clinic
- Investigators
- Matthew Abdel, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00493792
- Sponsor's protocol ID
- 06-003093
- Status last verified
- Oct 2024
- First submitted
- 26 Jun 2007
- Last updated
- 6 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Study Comparing the Survival for X-3 Polyethylene to N2Vac Polyethylene When Used With the Triathlon Posterior Stabilized (PS) Total Knee System.
- ClinicalTrials.gov ID
- NCT00493792
- Acronym / sponsor ID
- 06-003093
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 518 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Stryker Orthopaedics
- Study start
- Feb 2007
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 28 Jun 2007 (estimated)
- Results
- Posted 6 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare two types of polyethylene (Stryker Orthopaedics N2Vac and their X3 polyethylene) prostheses that are used in total knee replacements. The primary outcome will analyze whether or not prostheses require a revision surgery 10 years post knee replacement. Other outcomes such as reoperation rate, complications, radiographic results, and clinical outcomes will be collected.
It is hypothesized that X3 would perform equally well to N2Vac at 10 years.
Detailed description
This is a prospective, randomized and blinded clinical trial. Participants will be assessed pre-operatively and post-operatively at three months and two, five, seven and ten years. The primary aim of the study is to compare the survivorship of two types of polyethylene (conventional N2Vac and highly cross-linked X3, both FDA approved via 510k clearance) used in a fixed-bearing total knee system in patients undergoing cemented total knee arthroplasty. Specifically, the primary endpoint will be the revision rate at ten years. These results will be measured through radiographs at each post-operative interval with an independent radiograph review being performed after all patients have reached 7 and 10 year follow-up. Secondary results will also be collected and will focus on disease-specific (Knee Society Scores), global (SF-12), and outcome measures. Radiographic results consisting of standing anteroposterior, lateral and Merchant views of the surgical knee will be recorded and analyzed. Completion of the initial investigation will occur at the 10-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
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: N2Vac PolyethyleneStryker Orthopaedics N2Vac Polyethylene when used with a Triathlon Posterior Stabilized total knee system. This is a fixed- bearing knee intended for use in patients undergoing cemented total knee arthroplasty. |
| Treatment | Experimental | Device: X3 PolyethyleneStryker Orthopaedics X3 Polyethylene when used with a Triathlon Posterior Stabilized total knee system. This is a fixed- bearing knee intended for use in patients undergoing cemented total knee arthroplasty. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects willing to sign the informed consent.
- Subjects able to comply with follow-up requirements including post-operative weight bearing restrictions and self-evaluations.
- Male and non-pregnant female subjects ages 21-85 years of age at the time of surgery.
- Subjects requiring a primary total knee replacement.
- Subjects with a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
Key exclusion criteria (10 listed)
- Subjects with inflammatory arthritis.
- Subjects with a history of total or unicompartmental reconstruction of the affected joint.
- Subjects that have had a high tibial osteotomy or femoral osteotomy.
- Subjects with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
- Subjects with a systemic or metabolic disorder leading to progressive bone deterioration.
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 |
|---|---|---|
| X3 PolyethyleneAlso: X3Highly cross-linked polyethylene (HXLPE). | Device | Treatment |
| N2Vac PolyethyleneAlso: N2VacUltra-high-molecular-weight polyethylene (UHMWPE). | Device | Control |
Primary outcome
Prosthesis Survivorship Free of Revision
Time frame: From operation to 10 years post-operative
The survival of prostheses free of revision 10 years post operation.
7 secondary outcomes
Prosthesis Survivorship Free of Reoperation
Time frame: From operation to 10 years post-operative
Prosthesis Survivorship Free of Complications
Time frame: From operation to 10 years post-operative
Knee Society Score (KSS)
Time frame: Pre-operative (baseline) and 10-years post-operative
Knee Society Score (KSS): Function
Time frame: Pre-operative (baseline) and 10-years post-operative
12-Item Short Form Health Survey (SF-12): Mental Health Score
Time frame: Pre-operative (baseline) and 10-years post-operative
12-Item Short Form Health Survey (SF-12): Physical Health Score
Time frame: Pre-operative (baseline) and 10-years post-operative
Comparison of Radiographic Success/Failure Between Groups
Time frame: 10 years post-operative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Matthew Abdel, MD principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing X3 Polyethylene and N2Vac Polyethylene in people with Arthroplasty, Replacement, Knee and Total Knee Replacement, run by Mayo Clinic at 3 sites 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 6 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 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 6 Nov 2024). 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?
Prosthesis Survivorship Free of Revision (time frame: From operation to 10 years post-operative). 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 6 Nov 2024.