NitrX Total Knee Arthroplasty RSA

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05151315
• Other study ID #: 119937
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: November 30, 2024

Study information

• Verified date: May 2023
• Source: Lawson Health Research Institute
• Contact: Lyndsay Somerville, PhD
• Phone: 519 685 8500
• Email: lyndsay.somerville[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Radiostereometric Analysis
• Total Knee Arthroplasty

Intervention

Device:
• Total Knee Arthroplasty with Evolution® NitrX™ Knee System
Patients will receive cemented Evolution knee system with NitrX coating for their total knee arthroplasty.
• Total Knee Arthroplasty with Evolution Knee System
Patients will receive cemented Evolution knee system without NitrX coating for their total knee arthroplasty.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	MicroPort Orthopedics Inc.

Country where clinical trial is conducted

Canada, 

References & Publications (11)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

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].

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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Wear Rates	Model based Radiostereometric Analysis (specialized Xrays) will be used to register the location of the femoral and tibial components in both standing and supine exams where the minimum joint space width between components on the medial and lateral condyles can be calculated as a measurement (in millimeters) of polyethylene wear.	2 weeks (baseline), 6 weeks, 3 months, 6 months, 1 year, and 2 years.
Other	Circulating metal levels	Patients will have blood drawn and the levels of circulating cobalt, chromium, and nickel will be measured in whole blood. One vial of blood will be drawn from the patient (in milliliters).	Pre-operative, 1 and 2 years post-operatively.
Other	Synovial Joint Inflammation observation	Patients will complete an MRI exam using metal artefact reduction sequences. Scans will be evaluated and scored for synovial inflammation and fibrosis, indicative of reactions to metal debris, and the presence of fibrous tissue at the bone-cement-implant interface, indicative of component loosening.	2 Years
Other	Knee Injury and Osteoarthritis Outcome score (KOOS)	Patient reported outcome measure. Holds 42 items that asks patient about pain, functional daily living, and sport and recreation. Questionnaire measures levels in frequency (never to always) and severity (none to extreme). Scores are from 0-100, with higher scores indicating no knee problems.	Pre-operative, 3 months, 1 year, and 2 year post-operative
Other	Forgotten Joint Score (FJS)	Patient reported outcome measure observing the ability of a patient to forget about a joint due to successful treatment. Contains 12 items with frequency level measurement (never to mostly). The higher the score (0-100), the less aware the patient is of their affected joint when performing daily activity.	Pre-operative, 3 months, 1 year, and 2 year post-operative
Other	Veterans-Rand 12 Item Health Survey (VR-12)	Patient reported outcome measure observing physical and mental health status of patient. Contains 14 items measuring levels of severity (excellent to poor) and frequency (None of the time to Yes, all of the time). Higher scores indicate higher quality of life and vice versa.	Pre-operative, 3 months, 1 year, and 2 year post-operative
Other	European Quality of Life - 5 Dimension (EQ-5D)	Patient reported outcome measure. Standardized 5 item instrument measuring generic health status of patient. The EQ5D uses a Likert scale which assesses five states (mobility, self care, usual care, pain and discomfort and anxiety and depression) at five different levels - none(0), slight(1), moderate(2), severe(3) or unable to perform(5). Levels are coded 1-5 and an index score is then generated. Higher scores indicate higher health status of patient.	Pre-operative, 3 months, 1 year, and 2 year
Other	Metal Exposure/Sensitivity	Patient reported outcome measure. Screening tool for noting pre-operative environmental metal exposures. Questionnaire contains Yes or No questions. Higher scores would indicate greater exposure and/or metal sensitivity.	Pre-operative
Primary	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.	2 years
Secondary	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.	2 years