Analyzing metal ion levels in blood after knee replacement surgery
Analysis of Metal Ion Concentrations After Robotic-assisted Total Knee Arthroplasty Compared to Conventional Total Knee Arthroplasty
This study is testing whether the type of knee replacement surgery—robotic-assisted or traditional—affects the levels of metal ions in the blood of patients after their surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06447922 on ClinicalTrials.gov |
What this trial studies
This study examines the concentrations of metal ions in the blood of patients who undergo total knee arthroplasty (TKA), comparing those who receive robotic-assisted surgery to those who have conventional surgery using cutting guides. A total of 50 participants will have their blood tested for Cobalt, Chromium, Titanium, and Nickel before and after the procedure. The study is designed as a prospective cohort analysis, gathering baseline characteristics and follow-up data to assess the impact of the surgical approach on metal ion levels.
Who should consider this trial
Good fit: Ideal candidates include adults undergoing their first total knee arthroplasty, either conventionally or with robotic assistance.
Not a fit: Patients who have had previous knee surgeries or have metal implants from other injuries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the safety and outcomes of robotic-assisted knee surgeries compared to traditional methods.
How similar studies have performed: While studies on metal ion levels post-arthroplasty exist, this specific comparison between robotic-assisted and conventional techniques is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults undergoing conventional or robotic-assisted TKA * Consent to the study Exclusion Criteria: * 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.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Matthew P Abdel — Mayo Clinic
- Study coordinator: Gabe Schouten
- Email: schouten.gabe@mayo.edu
- Phone: (507) 266-5895
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.