Metal Ion Concentrations After Total Knee Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-25

Study Completion Date

2026-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Arthroplasty, Replacement, Knee Total Knee Replacement Blood Metal Ion Concentration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Conventional TKA with Cutting Guides

Patients undergoing a conventional total knee arthroplasty with cutting guides (no robot-assistance).

Metal ion level testing

Intervention Type OTHER

Patients will undergo a pre- and post-operative blood draw to analyze metal ion levels (Cobalt, Chromium, Titanium and Nickel)

Robot-Assisted TKA

Patients undergoing a robot-assisted total knee arthroplasty.

Metal ion level testing

Intervention Type OTHER

Patients will undergo a pre- and post-operative blood draw to analyze metal ion levels (Cobalt, Chromium, Titanium and Nickel)

Interventions

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Metal ion level testing

Patients will undergo a pre- and post-operative blood draw to analyze metal ion levels (Cobalt, Chromium, Titanium and Nickel)

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes