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AzTrials

Total Knee ArthroplastyNCT05151315

NitrX Total Knee Arthroplasty RSA

A study testing Total Knee Arthroplasty with Evolution® NitrX™ Knee System and Total Knee Arthroplasty with Evolution Knee System in people with Total Knee Arthroplasty and Knee Osteoarthritis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Metal hypersensitivity is a recognized complication in some patients following total joint arthroplasty. This can result in a reaction to metal particles from the implants placed in the joint and cause tissue injury. Read more about this study

Who is it for?
Ages 21 to 80 years
What is being tested?
Total Knee Arthroplasty with Evolution® NitrX™ Knee System and Total Knee Arthroplasty with Evolution Knee System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteCanada
Study dates
1 Aug 2022to Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty
  • Varus knee deformity of 0 to 10 degrees
  • Sufficient ligamentous function to warrant retention of the posterior cruciate ligament
  • Between ages of 21 and 80 inclusive
  • Patients willing and able to comply with follow-up requirements and self-evaluations
  • Ability to give informed consent
  • No contraindications to Magnetic Resonance Imaging (MRI)

Who cannot join

  • Active or previous infection
  • Medical condition precluding major surgery
  • Inflammatory arthropathy
  • Prior Patellectomy
  • PCL deficiency
  • Major Coronal plane deformity
  • Valgus deformity
  • Bone defects requiring augments, cones and/or stemmed implants

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • London Health Sciences Centre

    London, Ontario, N6A5A5

Other trials in Canada

About this study

Official title: Component Migration, Polyethylene Wear, and Joint Inflammation of the Evolution Versus Evolution NitrX Total Knee Arthroplasty System

Metal hypersensitivity is a recognized complication in some patients following total joint arthroplasty. This can result in a reaction to metal particles from the implants placed in the joint and cause tissue injury. The Evolution® NitrX™ (MicroPort Orthopaedics, Memphis, TN) knee implant was designed with the addition of a coating meant to create a barrier against the release of metal ions. The primary purpose of this study is to compare the Evolution and Evolution NitrX implant (implants your surgeon uses in total knee arthroplasty surgery). This study will compare the stability of these knee implants (any movement the implant makes after surgery) through the use of specialized xrays, called "radiostereometric analysis" (RSA for short). The investigators will also compare levels of circulating metal particles with blood draws and the effects of any circulating metal with MR imaging. The investigators will also be looking at the participants clinical outcomes using joint function and patient satisfaction questionnaires. A total of 50 patients will be enrolled into the study.

Being tested
Total Knee Arthroplasty with Evolution® NitrX™ Knee System, Total Knee Arthroplasty with Evolution Knee System
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Total Knee Arthroplasty with Evolution® NitrX™ Knee SystemDevice

    Patients will receive cemented Evolution knee system with NitrX coating for their total knee arthroplasty.

  • Total Knee Arthroplasty with Evolution Knee SystemDevice

    Patients will receive cemented Evolution knee system without NitrX coating for their total knee arthroplasty.

Study groups in NCT05151315
Study groupRoleWhat they receive
Evolution Total Knee Arthroplasty systemActive comparatorPatients will undergo total knee arthroplasty with the Evolution Total Knee System
Receives: Device: Total Knee Arthroplasty with Evolution Knee System
Evolution with NitrX Total Knee Arthroplasty systemExperimentalPatients will undergo total knee arthroplasty with the NitrX Evolution Total Knee System which has the specialized protective coating
Receives: Device: Total Knee Arthroplasty with Evolution® NitrX™ Knee System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Implant Migration (Tibial Component)

    Model based Radiostereometric Analysis (RSA, specialized Xrays) will be used to register the location of the tibial implant components during supine and standing exams and measure implant movement. Changes throughout the different time points of potential tibial migration, with the use of the tibial bone beads, will be measured in millimeters.

    Measured: 2 years

Secondary outcomes (1)

  1. Implant Migration (Femoral Component)

    Model based Radiostereometric Analysis (specialized Xrays) will be used to register the location of the femoral components during supine and standing exams and measure implant movement. Changes throughout the different time points of potential femoral migration, with the use of the femoral bone beads, will be measured in millimeters.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2021
  2. Study start1 Aug 2022
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05151315
Sponsor's protocol ID
119937
Status last verified
Sep 2026
First submitted
5 Nov 2021
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pijls BG, Plevier JWM, Nelissen RGHH. RSA migration of total knee replacements. Acta Orthop. 2018 Jun;89(3):320-328. doi: 10.1080/17453674.2018.1443635. Epub 2018 Mar 6.

    PubMed 29508661

  • Teeter MG, Marsh JD, Howard JL, Yuan X, Vasarhelyi EM, McCalden RW, Naudie DDR. A randomized controlled trial investigating the value of patient-specific instrumentation for total knee arthroplasty in the Canadian healthcare system. Bone Joint J. 2019 May;101-B(5):565-572. doi: 10.1302/0301-620X.101B5.BJJ-2018-1323.R1.

    PubMed 31038991

  • Teeter MG, Thoren J, Yuan X, McCalden RW, MacDonald SJ, Lanting BA, Naudie DD. Migration of a cemented fixed-bearing, polished titanium tibial baseplate (Genesis II) at ten years : a radiostereometric analysis. Bone Joint J. 2016 May;98-B(5):616-21. doi: 10.1302/0301-620X.98B5.36865.

    PubMed 27143731

  • Teeter MG, Perry K, Yuan X, Howard JL, Lanting BA. The Effects of Resection Technique on Implant Migration in Single Radius Posterior-Stabilized Total Knee Replacement. J Knee Surg. 2020 Jan;33(1):78-83. doi: 10.1055/s-0038-1676462. Epub 2018 Dec 18.

    PubMed 30562833

  • Sealed Envelope Ltd.2012.Power calculator for continuous outcome non0-inferiority trial.[Online] Available from: https://www.sealedenvelope.com/power/continuous-noninferios/[Accessed Thu Jan 14 2021].

  • van Ijsseldijk EA, Valstar ER, Stoel BC, de Ridder R, Nelissen RG, Kaptein BL. Measuring polyethylene wear in total knee arthroplasty by RSA: differences between weight-bearing and non-weight-bearing positioning. J Orthop Res. 2014 Apr;32(4):613-7. doi: 10.1002/jor.22579. Epub 2014 Jan 7.

    PubMed 24395396

  • Teeter MG, Wihlidal J, McCalden RW, Yuan X, MacDonald SJ, Lanting BA, Naudie DD. Radiostereometric Analysis Permits In Vivo Measurement of Very Small Levels of Wear in TKA. Clin Orthop Relat Res. 2019 Jan;477(1):80-90. doi: 10.1097/CORR.0000000000000399.

    PubMed 30794231

  • Gascoyne T, Parashin S, Teeter M, Bohm E, Laende E, Dunbar M, Turgeon T. In vivo wear measurement in a modern total knee arthroplasty with model-based radiostereometric analysis. Bone Joint J. 2019 Nov;101-B(11):1348-1355. doi: 10.1302/0301-620X.101B11.BJJ-2018-1447.R2.

    PubMed 31674253

  • Koff MF, Burge AJ, Potter HG. Clinical magnetic resonance imaging of arthroplasty at 1.5 T. J Orthop Res. 2020 Jul;38(7):1455-1464. doi: 10.1002/jor.24606. Epub 2020 Feb 4.

    PubMed 31975444

  • Attard V, Li CY, Self A, Mann DA, Borthwick LA, O'Connor P, Deehan DJ, Kalson NS. Quantification of intra-articular fibrosis in patients with stiff knee arthroplasties using metal-reduction MRI. Bone Joint J. 2020 Oct;102-B(10):1331-1340. doi: 10.1302/0301-620X.102B10.BJJ-2020-0841.R1.

    PubMed 32993344

  • Heyse TJ, Chong le R, Davis J, Boettner F, Haas SB, Potter HG. MRI analysis of the component-bone interface after TKA. Knee. 2012 Aug;19(4):290-4. doi: 10.1016/j.knee.2011.05.011. Epub 2011 Jul 8.

    PubMed 21741843

Questions about this trial

What is this clinical trial studying?

A study testing Total Knee Arthroplasty with Evolution® NitrX™ Knee System and Total Knee Arthroplasty with Evolution Knee System in people with Total Knee Arthroplasty and Knee Osteoarthritis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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 7 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2026. 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Implant Migration (Tibial Component) (time frame: 2 years). 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 NCT05151315, which also lists 11 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 22 Sep 2026.

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NitrX Total Knee Arthroplasty RSA (NCT05151315) | AzTrials