Clinical trial NCT05151315: NitrX Total Knee Arthroplasty RSA
Official title: Component Migration, Polyethylene Wear, and Joint Inflammation of the Evolution Versus Evolution NitrX Total Knee Arthroplasty System
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Total Knee Arthroplasty
Knee Osteoarthritis
Radiostereometric Analysis
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: MicroPort Orthopedics Inc.
First posted: 2021-12-09
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Implant Migration (Tibial Component)
timeFrame: 2 years
Secondary outcomes:
measure: Implant Migration (Femoral Component)
timeFrame: 2 years
Other outcomes:
measure: Wear Rates
timeFrame: 2 weeks (baseline), 6 weeks, 3 months, 6 months, 1 year, and 2 years.
measure: Circulating metal levels
timeFrame: Pre-operative, 1 and 2 years post-operatively.
measure: Synovial Joint Inflammation observation
timeFrame: 2 Years
measure: Knee Injury and Osteoarthritis Outcome score (KOOS)
timeFrame: Pre-operative, 3 months, 1 year, and 2 year post-operative
measure: Forgotten Joint Score (FJS)
timeFrame: Pre-operative, 3 months, 1 year, and 2 year post-operative
measure: Veterans-Rand 12 Item Health Survey (VR-12)
timeFrame: Pre-operative, 3 months, 1 year, and 2 year post-operative
measure: European Quality of Life - 5 Dimension (EQ-5D)
timeFrame: Pre-operative, 3 months, 1 year, and 2 year
measure: Metal Exposure/Sensitivity
timeFrame: Pre-operative
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre
name: Edward M Vasarhelyi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: London Health Science Centre
name: Matthew Teeter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
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citation: 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.