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Nickel Sensitivity

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ClinicalTrials.gov Identifier: NCT04058743
Recruitment Status : Not yet recruiting
First Posted : August 15, 2019
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Craig J Della Valle, MD, Rush University Medical Center

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.

Condition or disease Intervention/treatment Phase
Knee Arthropathy Allergic Reaction Device: TKA with nickel free components Device: TKA with standard cobalt chromium components Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective randomized controlled trial with two groups: TKA with standard cobalt chromium components vs TKA with nickel free components.
Masking: Single (Participant)
Masking Description: Patients will be blinded to the type of implant that they receive.
Primary Purpose: Prevention
Official Title: Effect of Nickel Sensitivity on Patient Reported Outcomes After Total Knee Arthroplasty
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2030

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: TKA with standard cobalt chromium components
Patients randomized to this group will receive the standard cobalt chromium components in their total knee arthroplasty
Device: TKA with standard cobalt chromium components
Patients will be randomized to receive either the standard cobalt chromium components or nickel free components

Experimental: TKA with nickel free components
Patients randomized to this group will receive nickel free components in their total knee arthroplasty
Device: TKA with nickel free components
Patients will be randomized to receive either the standard cobalt chromium components or nickel free components




Primary Outcome Measures :
  1. Knee Society Score (KSS) [ Time Frame: 3 weeks, 6 weeks, 1 year, 2 years, 5 years, and 10 years. ]
    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.


Secondary Outcome Measures :
  1. Complications [ Time Frame: 90-days ]
    Any peri- or postoperative complications will be recorded including DVT/PE, return to the OR within 90 days, readmission within 90 days, superficial infection, deep infection, dermatitis, periprosthetic fracture, cerebrovascular accident/transient ischemic attack.

  2. Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) [ Time Frame: 3 weeks, 6 weeks, 1 year, 2 years, 5 years, and 10 years. ]
    Postoperative Knee Injury and Osteoarthritis Outcome Scores (KOOS JR) will also be recorded. This score is 0-100 with 100 being a perfectly functioning knee.

  3. Radiographic assessment for proper component alignment and any signs of loosening [ Time Frame: 3 weeks, 6 weeks, 1 year, 2 years, 5 years, and 10 years. ]
    In addition, routine radiographs (AP and lateral knee radiographs) will be obtained at follow-up visits and assessed for component alignment and signs of loosening.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04058743


Contacts
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Contact: Craig J Della Valle, MD (312)432-2468 craig.dellavalle@rushortho.com
Contact: Chris Culvern, MS chris.culvern@rushortho.com

Locations
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United States, Illinois
Rush University medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center

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Responsible Party: Craig J Della Valle, MD, Professor of Orthopaedic Surgery, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT04058743     History of Changes
Other Study ID Numbers: 18112703
First Posted: August 15, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Joint Diseases
Hypersensitivity
Immune System Diseases
Musculoskeletal Diseases
Cobalt
Chromium
Nickel
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs