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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 belowSelect...
I am having a knee replacement due to arthritis and I am allergic to nickel.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have health issues that prevent me from having knee replacement surgery.I am having a knee replacement due to arthritis and I am allergic to nickel.I am under 18 years old.I am having a second knee replacement surgery.
Research Study Groups:
This trial has the following groups:- Group 1: TKA with standard cobalt chromium components
- Group 2: TKA with nickel free components
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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