Metal Ion Concentrations After Total Knee Arthroplasty

Recruiting

• Conditions: Blood Metal Ion Concentration; Arthroplasty, Replacement, Knee; Total Knee Replacement
• Interventions: Other: Metal ion level testing

• Registration Number: NCT06447922
• Lead Sponsor: Mayo Clinic

Brief 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.

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 Timeline

• Study First Submitted: 2024-06-03
• Study First Submitted QC: 2024-06-03
• Study First Posted: 2024-06-07
• Study Start: 2024-06-25
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-19
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Conventional TKA with Cutting Guides	Metal ion level testing	Patients undergoing a conventional total knee arthroplasty with cutting guides (no robot-assistance).
Robot-Assisted TKA	Metal ion level testing	Patients undergoing a robot-assisted total knee arthroplasty.

Primary Outcome Measures

Name	Time	Method
Overall blood metal ion differences between procedures (Conventional TKA vs Robot-Assisted TKA)	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.

Secondary Outcome Measures

Name	Time	Method
Comparison of post-operative blood metal levels between procedures: Cobalt	First post-operative day	Difference in post-operative levels, adjusted for the pre-operative levels, between Conventional TKA with Cutting Guides vs Robot-Assisted TKA
Comparison of post-operative blood metal levels between procedures: Chromium	First post-operative day	Difference in post-operative levels, adjusted for the pre-operative levels, between Conventional TKA with Cutting Guides vs Robot-Assisted TKA
Comparison of post-operative blood metal levels between procedures: Titanium	First post-operative day	Difference in post-operative levels, adjusted for the pre-operative levels, between Conventional TKA with Cutting Guides vs Robot-Assisted TKA
Comparison of post-operative blood metal levels between procedures: Nickel	First post-operative day	Difference in post-operative levels, adjusted for the pre-operative levels, between Conventional TKA with Cutting Guides vs Robot-Assisted TKA

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States