Nickel Sensitivity

NCT04058743 | Terminated Results FDA Device

• 1 other identifier: 18112703
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Arthropathy; Allergic Reaction

Outcome Measures

Primary Outcomes (1)

• Knee Society Score (KSS)

  Change from pre operative to post operative Knee Society Scores at various time intervals. KSS is scored 0-100 with 100 being a perfectly functioning knee and is used as a gauge of success for a knee replacement.

  3 weeks

Secondary Outcomes (5)

• Number of Participants With Complications

  90 days

• Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.)

  3 weeks

• Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.)

  6 weeks

• Number of Participants With Proper Component Alignment and *Without* Any Signs of Loosening

  3 weeks after surgery

• Number of Participants With Proper Component Alignment and *Without* Any Signs of Loosening

  6 weeks after surgery

Study Arms (2)

TKA with standard cobalt chromium components

ACTIVE COMPARATOR

Patients randomized to this group will receive the standard cobalt chromium components in their total knee arthroplasty

Device: TKA with standard cobalt chromium components

TKA with nickel free components

EXPERIMENTAL

Patients randomized to this group will receive nickel free components in their total knee arthroplasty

Device: TKA with nickel free components

Interventions

TKA with nickel free components DEVICE

Patients will be randomized to receive either the standard cobalt chromium components or nickel free components

TKA with nickel free components

TKA with standard cobalt chromium components DEVICE

Patients will be randomized to receive either the standard cobalt chromium components or nickel free components

TKA with standard cobalt chromium components

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients less than 18 years of age
• Patients undergoing revision TKA
• Non english speaking patients
• Patient who have medical comorbidities that prevent elective TKA

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Results Point of Contact

• Title: Anne DeBenedetti, MSc
• Organization: Rush University Medical Center

anne.debenedetti@rushortho.com

3124322468

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be blinded to the type of implant that they receive.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Orthopaedic Surgery

Model Details: Prospective randomized controlled trial with two groups: Total knee replacement with standard cobalt chromium components vs Total Knee Replacements with nickel free components.

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 15, 2019
• Study Start: September 27, 2019
• Primary Completion: December 11, 2024
• Study Completion: December 21, 2024
• Last Updated: May 1, 2026
• Results First Posted: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)