Metal Ion Concentration Between Coated and Uncoated TKA

NCT ID: NCT03047564

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-01
• Study Completion Date: 2020-12-01

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Coated Total Knee Arthroplasty

Implantation of a coated Total Knee Arthroplasty

Group Type: EXPERIMENTAL

Coated Total Knee Arthroplasty

Intervention Type: DEVICE

Implantation of a coated Total Knee Arthroplasty

Standard Total Knee Arthroplasty

Implantation of a Standard Total Knee Arthroplasty

Group Type: ACTIVE_COMPARATOR

Standard Total Knee Arthroplasty

Intervention Type: DEVICE

Implantation of a Standard Total Knee Arthroplasty

Interventions

Coated Total Knee Arthroplasty

Implantation of a coated Total Knee Arthroplasty

Intervention Type: DEVICE

Standard Total Knee Arthroplasty

Implantation of a Standard Total Knee Arthroplasty

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mathys Ltd Bettlach

INDUSTRY

Sponsor Role: collaborator

Technische Universität Dresden

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jörg Lützner, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Carl Gustav Carus

Other Identifiers

TKAcoated

Identifier Type: -

Identifier Source: org_study_id