Metal Ion Concentration Between Coated and Uncoated TKA

Metal Ion Concentration and Clinical Outcome Between Coated and Uncoated TKA

Metal ion release from metal implants may have side effects. It can be reduced by coating of the implant. This study compares coated and uncoated TKA.

Study Overview

• Status: Unknown
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: Coated Total Knee Arthroplasty; Device: Standard Total Knee Arthroplasty

Detailed Description

Patients are randomized to receive a coated or uncoated TKA. Patients are assessed before surgery, after 3 month, 1 year and 5 years.

Blood samples are collected in 7.5 ml S-Monovette® tubes (for trace metal analysis, Sarstedt AG, Germany) using a specific steel needle for trace metal analysis (Sarstedt AG, Germany). Within one hour, plasma was separated by centrifugation at 2500g for ten minutes. Samples were stored at -20°C before being analysed for chromium, cobalt, molybdenum and nickel content using a graphite furnace atomic absorption spectrometer Z-8270 with Polarisation-Zeeman-Absorption (Hitachi Ltd., Japan). The accuracy and precision of the method is validated to < 10% using the control materials SeronormTM Trace Elements Serum (SERO AS, Norway). The detection limit of the method is estimated at 0.5µg/l for chromium, cobalt and molybdenum, 1.0µg/l for nickel (mean + 3 standard deviations from buffer). All probes having ion levels below the detection limit were adjusted to 0.25µg/l for chromium, cobalt and molybdenum and 0.5µg/l for nickel.

Clinical outcome is measured with the Knee Society Score, Oxford Knee Score, Short-Form 36 and University of Los Angeles Activity Score.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• indication to TKA
• no other metal implant

Exclusion Criteria:

• no informed consent
• not able to understand study and/or questionnaires
• Need of a higher constrained implant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Coated Total Knee Arthroplasty; Implantation of a coated Total Knee Arthroplasty	Device: Coated Total Knee Arthroplasty; Implantation of a coated Total Knee Arthroplasty
Active Comparator: Standard Total Knee Arthroplasty; Implantation of a Standard Total Knee Arthroplasty	Device: Standard Total Knee Arthroplasty; Implantation of a Standard Total Knee Arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metal Ions (Cobalt, Chromium, Molydenum, Nickel)	Change in Serum Metal Ion concentrations 1 and 5 years after surgery	before surgery, 1 year, 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Function	Knee Society Score	before surgery, 3 month, 1 year, 5 years
Patient Reported Outcome	Oxford Knee Score	before surgery, 3 month, 1 year, 5 years
Health-related Quality of Life	SF 36	before surgery, 3 month, 1 year, 5 years
Activity	UCLA activity score	before surgery, 3 month, 1 year, 5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Adverse Events	through study completion, in average 5 years

Collaborators and Investigators

• Sponsor: Technische Universität Dresden
• Collaborators: Mathys Ltd Bettlach
• Investigators: Principal Investigator: Jörg Lützner, MD, University Hospital Carl Gustav Carus

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2012
• Primary Completion (Actual): February 28, 2015
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: January 24, 2017
• First Submitted That Met QC Criteria: February 6, 2017
• First Posted (Estimate): February 9, 2017

Study Record Updates

• Last Update Posted (Actual): January 29, 2020
• Last Update Submitted That Met QC Criteria: January 28, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Total Knee Arthroplasty; Outcome; Total Knee Replacement; Metal ion concentration; Results
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: TKAcoated

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No