OsteoarthritisNCT00862511
Serum Metal Ion Concentration After Total Knee Arthroplasty (TKA)
A study testing Coated Total Knee Arthroplasty and Standard Total Knee Arthroplasty in people with Osteoarthritis and Metal Ion Levels, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
All metal implants release metal ions because of corrosion. Total knee arthroplasty implants have large metal surface areas and therefore substantial potential for corrosion. It is planned to compare changes in serum levels of metal ions in patients after implantation of cemented unconstrained total knee arthroplasty… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Metal Ion Levels
- 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
- 1 siteGermany
- Study dates
- Mar 2009to Jan 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Indication for TKA in primary oder secondary osteoarthritis of the knee
- Patient's consent
Who cannot join
- Additional Implants present
- Allergy against constituents of implant or cement
- Any malignancies
- Renal insufficiency
- Any additional serious disease complicating the participation in this study
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Dresden, Orthopaedic Department
Dresden, 01307
About this study
Official title: A Prospective Randomized Comparison of Serum Metal Ion Levels After Implantation of Coated and Uncoated Knee Prostheses
All metal implants release metal ions because of corrosion. Total knee arthroplasty implants have large metal surface areas and therefore substantial potential for corrosion. It is planned to compare changes in serum levels of metal ions in patients after implantation of cemented unconstrained total knee arthroplasty covered with or without a passivating surface. Serum concentrations of chromium, cobalt, molybdenum and nickel will be analyzed and compared between the two groups, as well as with those of 130 control patients without implants.
- Conditions
- Osteoarthritis, Metal Ion Levels
- Being tested
- Coated Total Knee Arthroplasty, Standard Total Knee Arthroplasty
- Keywords
- metal ion concentration, total knee arthroplasty, metal hypersensitivity
- Medical subject headings
- Osteoarthritis
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 | allergy coated TKA Receives: Device: Coated Total Knee Arthroplasty |
| Standard Total Knee Arthroplasty | Active comparator | normal TKA Receives: Device: Standard Total Knee Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metal ion concentration in serum after TKA (Cr, Co, Mb, Ni)
Measured: 1 y and 5y
Secondary outcomes (1)
Hypersensitivity against metal
Measured: 1 y
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2012
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Aesculap AG
- Responsible party
- Sponsor
- Investigators
- Jörg Lützner, MD, Principal investigator, University Hospital Dresden, Orthopaedic DepartmentStephan Kirschner, MD, Principal investigator, University Hospital Dresden, Orthopaedic Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00862511
- Sponsor's protocol ID
- KneeIon
- Status last verified
- Jan 2017
- First submitted
- 16 Mar 2009
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lutzner J, Beyer F, Lutzner C, Thomas P, Summer B. Increased inflammatory response is associated with less favorable functional results 5 years after total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2023 Apr;31(4):1316-1322. doi: 10.1007/s00167-021-06836-w. Epub 2022 Feb 11.
PubMed 35147719Lutzner J, Dinnebier G, Hartmann A, Gunther KP, Kirschner S. Study rationale and protocol: prospective randomized comparison of metal ion concentrations in the patient's plasma after implantation of coated and uncoated total knee prostheses. BMC Musculoskelet Disord. 2009 Oct 14;10:128. doi: 10.1186/1471-2474-10-128.
PubMed 19828019
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Comparison of Serum Metal Ion Levels After Implantation of Coated and Uncoated Knee Prostheses
- ClinicalTrials.gov ID
- NCT00862511
- Acronym / sponsor ID
- KneeIon
- Conditions
- Osteoarthritis, Metal Ion Levels
- Keywords
- metal ion concentration, total knee arthroplasty, metal hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Aesculap AG
- Study start
- Mar 2009 (actual)
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 17 Mar 2009 (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.
All metal implants release metal ions because of corrosion. Total knee arthroplasty implants have large metal surface areas and therefore substantial potential for corrosion. It is planned to compare changes in serum levels of metal ions in patients after implantation of cemented unconstrained total knee arthroplasty covered with or without a passivating surface. Serum concentrations of chromium, cobalt, molybdenum and nickel will be analyzed and compared between the two groups, as well as with those of 130 control patients without implants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coated Total Knee Arthroplasty | Experimental | Device: Coated Total Knee Arthroplastyallergy coated TKA |
| Standard Total Knee Arthroplasty | Active comparator | Device: Standard Total Knee Arthroplastynormal TKA |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Indication for TKA in primary oder secondary osteoarthritis of the knee
- Patient's consent
Key exclusion criteria (5 listed)
- Additional Implants present
- Allergy against constituents of implant or cement
- Any malignancies
- Renal insufficiency
- Any additional serious disease complicating the participation in this study
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 ion concentration in serum after TKA (Cr, Co, Mb, Ni)
Time frame: 1 y and 5y
1 secondary outcome
Hypersensitivity against metal
Time frame: 1 y
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 25 Jan 2017.
- Derived from this study: PubMed 35147719Lutzner J, Beyer F, Lutzner C, Thomas P, Summer B. Increased inflammatory response is associated with less favorable functional results 5 years after total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2023 Apr;31(4):1316-1322. doi: 10.1007/s00167-021-06836-w. Epub 2022 Feb 11.
- Derived from this study: PubMed 19828019Lutzner J, Dinnebier G, Hartmann A, Gunther KP, Kirschner S. Study rationale and protocol: prospective randomized comparison of metal ion concentrations in the patient's plasma after implantation of coated and uncoated total knee prostheses. BMC Musculoskelet Disord. 2009 Oct 14;10:128. doi: 10.1186/1471-2474-10-128.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis
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Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Effect of Anti-inflammatory Diet in Osteoarthritis
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Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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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 Dresden, Orthopaedic Department
Stephan Kirschner, MD principal investigator
University Hospital Dresden, Orthopaedic Department
1 site in 1 country: see every site and its status.
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 Osteoarthritis and Metal Ion Levels, run by Technische Universität Dresden at 1 site in Germany.
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 5 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 25 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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 ion concentration in serum after TKA (Cr, Co, Mb, Ni) (time frame: 1 y and 5y). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00862511, which also lists 2 linked publications.
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 25 Jan 2017.