OsteoarthritisPhase 4NCT00665964
Comparing X-3 To N2vac Polyethylene With the Triathlon Total Knee System
A Phase 4 study testing X-3 polyethylene and N2Vac polethylene in people with Osteoarthritis and OA, run by Dalhousie University at 1 site in Canada.
Trial summary
Methodology: This study will be a randomized, multi-center evaluation comparing N2vac polyethylene inserts and patellas with X3 inserts and patellas when used in the Triathlon PS total knee system. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Osteoarthritis, OA
- What is being tested?
- X-3 polyethylene and N2Vac polethylene
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- May 2008to May 2020
- Phase
- Phase 4
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject requires a primary cemented total knee replacement.
- The subject has a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
- The subject has intact collateral ligaments.
- The subject has signed the ethic committee approved, study specific Informed Patient Consent Form.
- The subject is willing and able to comply with post-operative scheduled clinical and radiographic evaluations and rehabilitation.
Who cannot join
- The subject has inflammatory arthritis.
- The subject is morbidly obese, BMI > 40.
- The subject has a history of total or unicompartmental reconstruction of the affected joint.
- The subject has had a high tibial osteotomy or femoral osteotomy.
- The subject has a neuromuscular or neurosensory deficiency, that would limit the ability to assess the performance of the device.
- The subject has a systemic or metabolic disorder leading to progressive bone deterioration.
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- The subject is immunologically suppressed, or receiving chronic steroids (>30 days duration).
- The subject's bone stock is compromised by disease or infection and cannot provide adequate support and/or fixation to the prosthesis.
- The subject has had a knee fusion at the affected joint.
- The subject has an active or suspected latent infection in or about the knee joint.
- The subject is a prisoner.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Multi-center Study Comparing the Ten-Year Survival for X-3 Polyethylene to N2vac Polyethylene When Used With the Triathlon Posterior Stabilized (PS) Total Knee System
Methodology: This study will be a randomized, multi-center evaluation comparing N2vac polyethylene inserts and patellas with X3 inserts and patellas when used in the Triathlon PS total knee system.
Study Duration: 12-18 month enrollment period + 10 year follow-up for each case years total duration
Read more
Multi-centre study
Objectives
Primary: To compare the 10 year implant survival of the Triathlon PS total knee system when X3 polyethylene components are used to the same knee system when N2Vac components are used.
Secondary: To compare pain, function, radiographic outcomes, and health related quality of life of subjects in both treatment groups. Safety will be assessed by comparison of adverse events between the groups.
Number of Subjects 384 cases (197 each group)
- Conditions
- Osteoarthritis, OA
- Being tested
- X-3 polyethylene, N2Vac polethylene
- Keywords
- osteoarthritis, knee, total knee arthroplasty, gonarthrrsis, polyethylene, posterior stabilized
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X-3 polyethyleneDevice
highly cross-linked polyethylene for knee arthroplasty
N2Vac polethyleneDevice
conventional polyethylene
| Study group | Role | What they receive |
|---|---|---|
| X-3 | Experimental | X-3 polyethylene which is a new highly cross-linked poly that is theorized to be more durable in vivo Receives: Device: X-3 polyethylene |
| N2Vac polethylene | Active comparator | conventional polyethylene Receives: Device: N2Vac polethylene |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival rate of polyethylene
Measured: 10 years
Secondary outcomes (5)
pain
Measured: 10 years
function
Measured: 10 years
radiographic outcomes
Measured: 10 years
health related quality of life
Measured: 10 years
adverse events
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
Why it stopped: Not funded at this time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalhousie University
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Canada LP
- Responsible party
- Principal investigator, Michael Dunbar, Dalhousie University
- Investigators
- Michael J. Dunbar, Principal investigator, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00665964
- Sponsor's protocol ID
- CDHA-RS/2007-249
- Status last verified
- Jan 2019
- First submitted
- 22 Apr 2008
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multi-center Study Comparing the Ten-Year Survival for X-3 Polyethylene to N2vac Polyethylene When Used With the Triathlon Posterior Stabilized (PS) Total Knee System
- ClinicalTrials.gov ID
- NCT00665964
- Acronym / sponsor ID
- CDHA-RS/2007-249
- Conditions
- Osteoarthritis, OA
- Keywords
- osteoarthritis, knee, total knee arthroplasty, gonarthrrsis, polyethylene, posterior stabilized
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not funded at this time.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dalhousie UniversityUniversity, hospital or other
- Collaborators
- Stryker Canada LP
- Study start
- May 2008
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 24 Apr 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.
Methodology: This study will be a randomized, multi-center evaluation comparing N2vac polyethylene inserts and patellas with X3 inserts and patellas when used in the Triathlon PS total knee system.
Study Duration: 12-18 month enrollment period + 10 year follow-up for each case years total duration
Multi-centre study
Objectives
Primary: To compare the 10 year implant survival of the Triathlon PS total knee system when X3 polyethylene components are used to the same knee system when N2Vac components are used.
Secondary: To compare pain, function, radiographic outcomes, and health related quality of life of subjects in both treatment groups. Safety will be assessed by comparison of adverse events between the groups.
Number of Subjects 384 cases (197 each group)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| X-3 | Experimental | Device: X-3 polyethyleneX-3 polyethylene which is a new highly cross-linked poly that is theorized to be more durable in vivo |
| N2Vac polethylene | Active comparator | Device: N2Vac polethyleneconventional polyethylene |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The subject requires a primary cemented total knee replacement.
- The subject has a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
- The subject has intact collateral ligaments.
- The subject has signed the ethic committee approved, study specific Informed Patient Consent Form.
- The subject is willing and able to comply with post-operative scheduled clinical and radiographic evaluations and rehabilitation.
Key exclusion criteria (11 listed)
- The subject has inflammatory arthritis.
- The subject is morbidly obese, BMI > 40.
- The subject has a history of total or unicompartmental reconstruction of the affected joint.
- The subject has had a high tibial osteotomy or femoral osteotomy.
- The subject has a neuromuscular or neurosensory deficiency, that would limit the ability to assess the performance of the device.
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 |
|---|---|---|
| X-3 polyethylenehighly cross-linked polyethylene for knee arthroplasty | Device | X-3 |
| N2Vac polethyleneconventional polyethylene | Device | N2Vac polethylene |
Primary outcome
survival rate of polyethylene
Time frame: 10 years
5 secondary outcomes
pain
Time frame: 10 years
function
Time frame: 10 years
radiographic outcomes
Time frame: 10 years
health related quality of life
Time frame: 10 years
adverse events
Time frame: 10 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
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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.
Michael J. Dunbar principal investigator
Dalhousie University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing X-3 polyethylene and N2Vac polethylene in people with Osteoarthritis and OA, run by Dalhousie University at 1 site in Canada.
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 5 inclusion and 11 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: withdrawn, as of the sponsor's last update on 31 Jan 2019. 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
survival rate of polyethylene (time frame: 10 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 31 Jan 2019.