Metal Ion Concentration Between Coated and Uncoated TKA

Knee Osteoarthritis Clinical Trial

Official title:

Metal Ion Concentration and Clinical Outcome Between Coated and Uncoated TKA

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03047564
• Other study ID #: TKAcoated
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2012
• Est. completion date: December 1, 2020

Study information

• Verified date: January 2020
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 1, 2020
• Est. primary completion date: February 28, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Coated Total Knee Arthroplasty
Implantation of a coated Total Knee Arthroplasty
• Standard Total Knee Arthroplasty
Implantation of a Standard Total Knee Arthroplasty

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Technische Universität Dresden	Mathys Ltd Bettlach

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events	Adverse Events	through study completion, in average 5 years
Primary	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	Function	Knee Society Score	before surgery, 3 month, 1 year, 5 years
Secondary	Patient Reported Outcome	Oxford Knee Score	before surgery, 3 month, 1 year, 5 years
Secondary	Health-related Quality of Life	SF 36	before surgery, 3 month, 1 year, 5 years
Secondary	Activity	UCLA activity score	before surgery, 3 month, 1 year, 5 years