Knee OsteoarthritisNCT03047564
Metal Ion Concentration Between Coated and Uncoated TKA
A study testing Coated Total Knee Arthroplasty and Standard Total Knee Arthroplasty in people with Knee Osteoarthritis, run by Technische Universität Dresden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Coated Total Knee Arthroplasty and Standard Total Knee Arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2012to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- indication to TKA
- no other metal implant
Who cannot join
- no informed consent
- not able to understand study and/or questionnaires
- Need of a higher constrained implant
About this study
Official title: 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.
Read the 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
- Being tested
- Coated Total Knee Arthroplasty, Standard Total Knee Arthroplasty
- Keywords
- Total Knee Arthroplasty, Total Knee Replacement, Outcome, Metal ion concentration, Results
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coated Total Knee ArthroplastyDevice
Implantation of a coated Total Knee Arthroplasty
Standard Total Knee ArthroplastyDevice
Implantation of a Standard Total Knee Arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Coated Total Knee Arthroplasty | Experimental | Implantation of a coated Total Knee Arthroplasty Receives: Device: Coated Total Knee Arthroplasty |
| Standard Total Knee Arthroplasty | Active comparator | Implantation of a Standard Total Knee Arthroplasty Receives: Device: Standard Total Knee Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metal Ions (Cobalt, Chromium, Molydenum, Nickel)
Change in Serum Metal Ion concentrations 1 and 5 years after surgery
Measured: before surgery, 1 year, 5 years
Secondary outcomes (4)
Function
Knee Society Score
Measured: before surgery, 3 month, 1 year, 5 years
Patient Reported Outcome
Oxford Knee Score
Measured: before surgery, 3 month, 1 year, 5 years
Health-related Quality of Life
SF 36
Measured: before surgery, 3 month, 1 year, 5 years
Activity
UCLA activity score
Measured: before surgery, 3 month, 1 year, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start1 Feb 2012
- Primary completion28 Feb 2015
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization to one of two implants
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Mathys Ltd Bettlach
- Responsible party
- Sponsor
- Investigators
- Jörg Lützner, MD, Principal investigator, University Hospital Carl Gustav Carus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047564
- Sponsor's protocol ID
- TKAcoated
- Status last verified
- Feb 2021
- First submitted
- 24 Jan 2017
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metal Ion Concentration and Clinical Outcome Between Coated and Uncoated TKA
- ClinicalTrials.gov ID
- NCT03047564
- Acronym / sponsor ID
- TKAcoated
- Conditions
- Knee Osteoarthritis
- Keywords
- Total Knee Arthroplasty, Total Knee Replacement, Outcome, Metal ion concentration, Results
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Mathys Ltd Bettlach
- Study start
- 1 Feb 2012 (actual)
- Primary completion
- 28 Feb 2015 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 9 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization to one of two implants
| Arm | Type | Receives |
|---|---|---|
| Coated Total Knee Arthroplasty | Experimental | Device: Coated Total Knee ArthroplastyImplantation of a coated Total Knee Arthroplasty |
| Standard Total Knee Arthroplasty | Active comparator | Device: Standard Total Knee ArthroplastyImplantation of a Standard Total Knee Arthroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- indication to TKA
- no other metal implant
Key exclusion criteria (3 listed)
- no informed consent
- not able to understand study and/or questionnaires
- Need of a higher constrained implant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coated Total Knee ArthroplastyImplantation of a coated Total Knee Arthroplasty | Device | Coated Total Knee Arthroplasty |
| Standard Total Knee ArthroplastyImplantation of a Standard Total Knee Arthroplasty | Device | Standard Total Knee Arthroplasty |
Primary outcome
Metal Ions (Cobalt, Chromium, Molydenum, Nickel)
Time frame: before surgery, 1 year, 5 years
Change in Serum Metal Ion concentrations 1 and 5 years after surgery
4 secondary outcomes
Function
Time frame: before surgery, 3 month, 1 year, 5 years
Patient Reported Outcome
Time frame: before surgery, 3 month, 1 year, 5 years
Health-related Quality of Life
Time frame: before surgery, 3 month, 1 year, 5 years
Activity
Time frame: before surgery, 3 month, 1 year, 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jörg Lützner, MD principal investigator
University Hospital Carl Gustav Carus
Questions about this trial
What is this clinical trial studying?
A study testing Coated Total Knee Arthroplasty and Standard Total Knee Arthroplasty in people with Knee Osteoarthritis, run by Technische Universität Dresden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metal Ions (Cobalt, Chromium, Molydenum, Nickel) (time frame: before surgery, 1 year, 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.