TerminatedNot Applicable

Nickel Sensitivity

Stopped: We have decided to stop the study due to lack of enrollment

United States9 participantsStarted 2019-09-27

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * Patients less than 18 years of age * Patients undergoing revision TKA * Non english speaking patients * Patient who have medical comorbidities that prevent elective TKA

What they're measuring

Knee Society Score (KSS)

Timeframe: 3 weeks

Trial details

NCT IDNCT04058743

SponsorRush University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-11

Results submitted2026-01-11

View on ClinicalTrials.gov More Knee Arthropathy trials