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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates the effectiveness of nickel-free knee implants compared to standard ones in individuals with a self-reported nickel allergy. It aims to determine differences in recovery and functionality between those with and without a nickel allergy. Participants will receive either a nickel-free implant or a standard cobalt chromium implant during knee replacement surgery, assigned randomly. Individuals with osteoarthritis or inflammatory arthritis planning knee replacement and having a nickel allergy might be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance knee replacement options for people with nickel allergies.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these knee implants are safe for patients with nickel sensitivity?

A previous study found that patients with a nickel allergy who received knee implants without nickel had similar outcomes to those with regular implants. The research showed no difference in the need for follow-up surgeries or overall health outcomes. This suggests that implants without nickel are generally well-tolerated, even for those sensitive to nickel. Another study found that a nickel allergy did not lead to worse results after knee replacement, regardless of whether the implant contained nickel. This supports the idea that nickel-free parts are a safe choice for knee surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about nickel-free knee implants because they offer a new option for patients with metal allergies, particularly those sensitive to nickel, which is commonly found in standard knee implants. Most traditional knee implants use cobalt chromium components that contain nickel, potentially causing allergic reactions in some patients. The nickel-free implants provide an alternative that could reduce the risk of allergic reactions, offering a more comfortable and safer solution for these individuals. This innovation could lead to improved patient outcomes and satisfaction for those who struggle with metal allergies.

What evidence suggests that this trial's treatments could be effective for knee implant allergy?

This trial will compare the effectiveness of nickel-free knee implants with standard cobalt chromium implants for individuals with nickel allergies. Studies have shown that knee implants without nickel are just as effective for people allergic to nickel as regular implants are for others. Research indicates that people with nickel allergies who undergo total knee replacement surgery do not experience worse results with nickel-free implants. Specifically, one study found no difference in the frequency of implant replacement or overall outcomes between those with nickel allergies using nickel-free implants and those without allergies using standard implants. This suggests that nickel-free implants offer a successful alternative for people sensitive to nickel, without affecting the surgery's success. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/pii/S2352344124000840

Hypoallergenic Knee Implant Usage and Clinical Outcomes

Despite its popularity, it is estimated that up to 20% of patients are not satisfied with the outcome of their TKA [2]. Allergic reaction to orthopaedic implant ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9438335/

The effect of Nickel hypersensitivity on the outcome of total ...

Patients undergoing TKA with no prior history of metal hypersensitivity do not seem to be at an increased risk of developing Nickel hypersensitivity.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04058743

Study Details | NCT04058743 | Nickel Sensitivity

The purpose of this study is to compare clinical outcomes of patients with self reported nickel sensitivity undergoing primary total knee arthroplasty (TKA) ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37100098/

A Comparison of Clinical Outcomes After Total Knee ...

Conclusion: In this retrospective cohort study, there was no difference in revision rates or clinical outcomes in patients who had a nickel allergy undergoing ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S2773157X2500092X

Impact of nickel allergy on total knee arthroplasty outcomes

The purpose of this study was to examine the outcomes following primary total knee arthroplasty (TKA) with nickel-containing implants in patients with a known ...

6.

nature.com

nature.com/articles/s41598-024-71256-y

Long term follow-up of a completely metal free total knee ...

However, the actual incidence of metal hypersensitivity to general metallic implants is less than 1%. Up to 60% of all patients with failure of ...

7.

arthroplastyjournal.org

arthroplastyjournal.org/article/S0883-5403(23)00742-8/abstract

Do Patients With Hypoallergenic Total Knee ...

Metal allergy is a rare and controversial cause of implant failure and poor outcomes following total knee arthroplasty (TKA).