Arthroplasty, Replacement, KneeNCT06447922
Metal Ion Concentrations After Total Knee Arthroplasty
An observational study of Arthroplasty, Replacement, Knee and Total Knee Replacement, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to analyze the metal ion concentrations in the patients blood following robotic-assisted total knee arthroplasty (TKA) compared to conventional total knee arthroplasty using cutting guides. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthroplasty, Replacement, Knee, Total Knee Replacement, Blood Metal Ion Concentration
- What is being tested?
- Metal ion level testing
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2024to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients eligible for a primary total knee replacement who have not had a prior joint replacement or surgery where metal implants were placed.
Who may be able to join
- Adults undergoing conventional or robotic-assisted TKA
- Consent to the study
Who cannot join
- Patients who have undergone any previous arthroplasty procedures.
- Patients with metal implants, such as plates, nails, and screws, used in the repair of traumatic injuries.
- Patients below 110 pounds.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Analysis of Metal Ion Concentrations After Robotic-assisted Total Knee Arthroplasty Compared to Conventional Total Knee Arthroplasty
The purpose of this study is to analyze the metal ion concentrations in the patients blood following robotic-assisted total knee arthroplasty (TKA) compared to conventional total knee arthroplasty using cutting guides.
Read the detailed description
This study focuses on comparing metal ion levels in 50 inpatient participants undergoing primary total knee arthroplasty (TKA) with either conventional cutting guides or robotic assistance. Baseline blood examinations for Cobalt, Chromium, Titanium, and Nickel will be performed before TKA implantation at preoperative visits and on the first day following the procedure. The investigation will encompass patients receiving both conventional and robotic-assisted primary TKA, framed within a prospective cohort study design. Baseline characteristics and additional follow-up information will be gathered.
- Being tested
- Metal ion level testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metal ion level testingOther
Patients will undergo a pre- and post-operative blood draw to analyze metal ion levels (Cobalt, Chromium, Titanium and Nickel)
| Study group | Role | What they receive |
|---|---|---|
| Conventional TKA with Cutting Guides | Patients undergoing a conventional total knee arthroplasty with cutting guides (no robot-assistance). Receives: Other: Metal ion level testing | |
| Robot-Assisted TKA | Patients undergoing a robot-assisted total knee arthroplasty. Receives: Other: Metal ion level testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall blood metal ion differences between procedures (Conventional TKA vs Robot-Assisted TKA)
Difference in overall blood metal ion levels (Cobalt, Chromium, Titanium, and Nickel) between patients undergoing total knee arthroplasty (TKA) with conventional cutting guides and those undergoing TKA with robotic assistance.
Measured: Pre-operatively, first post-operative day.
Secondary outcomes (4)
Comparison of post-operative blood metal levels between procedures: Cobalt
Difference in post-operative levels, adjusted for the pre-operative levels, between Conventional TKA with Cutting Guides vs Robot-Assisted TKA
Measured: First post-operative day
Comparison of post-operative blood metal levels between procedures: Chromium
Difference in post-operative levels, adjusted for the pre-operative levels, between Conventional TKA with Cutting Guides vs Robot-Assisted TKA
Measured: First post-operative day
Comparison of post-operative blood metal levels between procedures: Titanium
Difference in post-operative levels, adjusted for the pre-operative levels, between Conventional TKA with Cutting Guides vs Robot-Assisted TKA
Measured: First post-operative day
Comparison of post-operative blood metal levels between procedures: Nickel
Difference in post-operative levels, adjusted for the pre-operative levels, between Conventional TKA with Cutting Guides vs Robot-Assisted TKA
Measured: First post-operative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start25 Jun 2024
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew P. Abdel, M.D., Mayo Clinic
- Investigators
- Matthew P Abdel, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447922
- Sponsor's protocol ID
- 24-004661
- Status last verified
- Jul 2026
- First submitted
- 3 Jun 2024
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Metal Ion Concentrations After Robotic-assisted Total Knee Arthroplasty Compared to Conventional Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06447922
- Acronym / sponsor ID
- 24-004661
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 7 Jun 2024 (actual)
- 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.
The purpose of this study is to analyze the metal ion concentrations in the patients blood following robotic-assisted total knee arthroplasty (TKA) compared to conventional total knee arthroplasty using cutting guides.
Detailed description
This study focuses on comparing metal ion levels in 50 inpatient participants undergoing primary total knee arthroplasty (TKA) with either conventional cutting guides or robotic assistance. Baseline blood examinations for Cobalt, Chromium, Titanium, and Nickel will be performed before TKA implantation at preoperative visits and on the first day following the procedure. The investigation will encompass patients receiving both conventional and robotic-assisted primary TKA, framed within a prospective cohort study design. Baseline characteristics and additional follow-up information will be gathered.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional TKA with Cutting Guides | – | Other: Metal ion level testingPatients undergoing a conventional total knee arthroplasty with cutting guides (no robot-assistance). |
| Robot-Assisted TKA | – | Other: Metal ion level testingPatients undergoing a robot-assisted total knee arthroplasty. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients eligible for a primary total knee replacement who have not had a prior joint replacement or surgery where metal implants were placed.
Key inclusion criteria (2 listed)
- Adults undergoing conventional or robotic-assisted TKA
- Consent to the study
Key exclusion criteria (3 listed)
- Patients who have undergone any previous arthroplasty procedures.
- Patients with metal implants, such as plates, nails, and screws, used in the repair of traumatic injuries.
- Patients below 110 pounds.
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 |
|---|---|---|
| Metal ion level testingPatients will undergo a pre- and post-operative blood draw to analyze metal ion levels (Cobalt, Chromium, Titanium and Nickel) | Other | Conventional TKA with Cutting Guides, Robot-Assisted TKA |
Primary outcome
Overall blood metal ion differences between procedures (Conventional TKA vs Robot-Assisted TKA)
Time frame: Pre-operatively, first post-operative day.
Difference in overall blood metal ion levels (Cobalt, Chromium, Titanium, and Nickel) between patients undergoing total knee arthroplasty (TKA) with conventional cutting guides and those undergoing TKA with robotic assistance.
4 secondary outcomes
Comparison of post-operative blood metal levels between procedures: Cobalt
Time frame: First post-operative day
Comparison of post-operative blood metal levels between procedures: Chromium
Time frame: First post-operative day
Comparison of post-operative blood metal levels between procedures: Titanium
Time frame: First post-operative day
Comparison of post-operative blood metal levels between procedures: Nickel
Time frame: First post-operative day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Matthew P Abdel principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty, Replacement, Knee and Total Knee Replacement, run by Mayo Clinic at 1 site in United States.
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: enrolling by invitation, as of the sponsor's last update on 13 Jul 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Overall blood metal ion differences between procedures (Conventional TKA vs Robot-Assisted TKA) (time frame: Pre-operatively, first post-operative day.). 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 13 Jul 2026.