Nickel-Free vs Standard Knee Implants for Allergy

Overseen By Anne DeBenedetti, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Under 18, Revision TKA, Non-English, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1-2 weeks

8 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to compare clinical outcomes of patients with self reported nickel sensitivity undergoing primary total knee arthroplasty (TKA) with conventional, standard-of-care vs nickel-free implants. The hypothesis is that patients with a self-reported nickel sensitivity will have similar patient reported outcome scores compared to those patients without reported nickel sensitivity. Therefor the anticipation is for there to be no differences in other clinical outcome measures or functional outcome scores between the two cohorts.

Eligibility Criteria

This trial is for adults with knee arthritis who are getting a total knee arthroplasty (TKA) and have self-reported nickel allergies. They must be able to speak English and not have any medical conditions that would prevent them from having elective TKA.

Inclusion Criteria

I am having a knee replacement due to arthritis and I am allergic to nickel.

Exclusion Criteria

I have health issues that prevent me from having knee replacement surgery.

Non english speaking patients

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo total knee arthroplasty with either nickel-free or standard cobalt chromium components

1-2 weeks

1 visit (in-person for surgery)

Follow-up

Participants are monitored for safety, effectiveness, and complications after surgery

10 years

Regular follow-up visits with radiographic assessments

Treatment Details

Interventions

• TKA with nickel free components
• TKA with standard cobalt chromium components

Trial Overview The study aims to compare the outcomes of patients with nickel sensitivity undergoing knee replacement surgery using either standard cobalt chromium components or nickel-free implants.

Participant Groups

Group I: TKA with nickel free components Experimental Treatment 1 Intervention

Patients randomized to this group will receive nickel free components in their total knee arthroplasty

Group II: TKA with standard cobalt chromium components Active Control 1 Intervention

Patients randomized to this group will receive the standard cobalt chromium components in their total knee arthroplasty

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+