Metal Ion Concentration Between Coated and Uncoated TKA

Not Applicable

• Conditions: Knee Osteoarthritis
• Interventions: Device: Standard Total Knee Arthroplasty; Device: Coated Total Knee Arthroplasty

• Registration Number: NCT03047564
• Lead Sponsor: Technische Universität Dresden

Brief Summary

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.

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 Timeline

• Study Start: 2012-02-01
• Primary Completion: 2015-02-28
• Study First Submitted: 2017-01-24
• Study First Submitted QC: 2017-02-06
• Study First Posted: 2017-02-09
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-28
• Last Update Posted: 2020-01-29
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Total Knee Arthroplasty	Standard Total Knee Arthroplasty	Implantation of a Standard Total Knee Arthroplasty
Coated Total Knee Arthroplasty	Coated Total Knee Arthroplasty	Implantation of a coated Total Knee Arthroplasty

Primary Outcome Measures

Name	Time	Method
Metal Ions (Cobalt, Chromium, Molydenum, Nickel)	before surgery, 1 year, 5 years	Change in Serum Metal Ion concentrations 1 and 5 years after surgery

Secondary Outcome Measures

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