← Back to Search

Implant

Nickel-Free vs Standard Knee Implants for Allergy

N/A
Recruiting
Research Sponsored by Rush University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients undergoing primary TKA for the diagnosis of osteoarthritis or inflammatory arthritis with self-reported nickel allergy. Patients are routinely asked about nickel sensitivity as a part of the standard pre operative questionnaire already in place.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights

Study Summary

This trial is comparing two types of knee implants to see if there is a difference in patient reported outcome scores for those with nickel sensitivity.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects aren't listed, typical risks of knee replacement surgery may include pain, swelling, infection risk at the surgical site, blood clots, and possible reaction to implant materials.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am having a knee replacement due to arthritis and I am allergic to nickel.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Knee Society Score (KSS)
Secondary outcome measures
Complications
Estrogen Replacement Therapy
Radiographic assessment for proper component alignment and any signs of loosening

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TKA with nickel free componentsExperimental Treatment1 Intervention
Patients randomized to this group will receive nickel free components in their total knee arthroplasty
Group II: TKA with standard cobalt chromium componentsActive Control1 Intervention
Patients randomized to this group will receive the standard cobalt chromium components in their total knee arthroplasty

Find a Location

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor
419 Previous Clinical Trials
162,909 Total Patients Enrolled

Media Library

TKA with nickel free components (Implant) Clinical Trial Eligibility Overview. Trial Name: NCT04058743 — N/A
Knee Arthritis Research Study Groups: TKA with standard cobalt chromium components, TKA with nickel free components
Knee Arthritis Clinical Trial 2023: TKA with nickel free components Highlights & Side Effects. Trial Name: NCT04058743 — N/A
TKA with nickel free components (Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04058743 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many volunteers have enrolled in this research endeavor?

"Affirmative. Clinicaltrials.gov shows that this clinical trial is currently seeking participants, which was initially posted on September 27th 2019 and last modified on November 15th 2022. Approximately 90 patients are necessary to be recruited from a single medical center."

Answered by AI

Is recruitment still open for participants in this research endeavor?

"Per the information listed on clinicaltrials.gov, this research endeavour is in the process of recruiting willing participants since September 27th 2019 and was last amended November 15th 2022."

Answered by AI
~10 spots leftby Nov 2024