Metal Ion Concentration Between Coated and Uncoated TKA

Study Overview
=================
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.

Official Title
-----------------
Metal Ion Concentration and Clinical Outcome Between Coated and Uncoated TKA

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Device: Coated Total Knee Arthroplasty
* Device: Standard Total Knee Arthroplasty


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization to one of two implants
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coated Total Knee Arthroplasty<br>Implantation of a coated Total Knee Arthroplasty | Device: Coated Total Knee Arthroplasty<br>* Implantation of a coated Total Knee Arthroplasty<br>|
| Active Comparator: Standard Total Knee Arthroplasty<br>Implantation of a Standard Total Knee Arthroplasty | Device: Standard Total Knee Arthroplasty<br>* Implantation of a Standard Total Knee Arthroplasty<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Outcome, Total Knee Arthroplasty, Total Knee Replacement, Metal ion concentration, Results