TKA with nickel free components for Knee Arthritis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Knee Arthritis+1 MoreTKA with nickel free components - Device
Eligibility
18+
All Sexes
What conditions do you have?
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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.

Eligible Conditions
  • Knee Arthritis
  • Allergy

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 10 years

10 years
Estrogen Replacement Therapy
Knee Society Score (KSS)
Radiographic assessment for proper component alignment and any signs of loosening
90 days
Complications

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

TKA with standard cobalt chromium components
1 of 2
TKA with nickel free components
1 of 2

Active Control

Experimental Treatment

90 Total Participants · 2 Treatment Groups

Primary Treatment: TKA with nickel free components · No Placebo Group · N/A

TKA with nickel free components
Device
Experimental Group · 1 Intervention: TKA with nickel free components · Intervention Types: Device
TKA with standard cobalt chromium components
Device
ActiveComparator Group · 1 Intervention: TKA with standard cobalt chromium components · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 10 years

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor
388 Previous Clinical Trials
152,606 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

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