LEGION™ Revision Metal Hypersensitivity Study

March 8, 2016 updated by: Smith & Nephew, Inc.

A Prospective, Randomized, Multi-Center, Metal Hypersensitivity Study Comparing OXINIUM and Cobalt Chrome Femoral Components in Failed Total Knee Arthroplasty

This is a prospective, randomized, multi-center, metal hypersensitivity study comparing OXINIUM and cobalt chrome femoral components in subjects with failed total knee arthroplasty (TKA).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

A total of 230 subjects will be randomized (1:1) to receive either an OXINIUM or cobalt chrome femoral components as part of their LEGION revision procedure. The objective of this study is to assess a lower serum metal ion concentration level in at least one of the three major mLTTs (Co, Cr or Ni) over 5 years in subjects receiving OXINIUM versus Cobalt Chrome femoral components as part of the LEGION Revision Total Knee System.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2K2M9
        • Orthopaedic Innovation Centre
  • United States
    • New Jersey
      • Egg Harbor Township, New Jersey, United States, 08234
        • Rothman Institute
    • New York
      • New York, New York, United States, 10038
        • Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject is skeletally mature
  • Subject is willing to sign and date an IRB/EC approved consent form
  • Subject is a candidate for a revision knee replacement
  • Subject has met an acceptable preoperative medical clearance and is free or treated for cardiac, pulmonary, hematological, infection, or other conditions that would pose excessive operative risk
  • Subject agrees to adhere to the 10-year study visit schedule

Exclusion Criteria:

  • Subject with a known metal hypersensitivity
  • Subject requires a known bilateral revision TKA
  • Subject has severe pronation of the ipsilateral foot or any other relevant clinical condition contributing to abnormal ambulation
  • Subject has active infection or sepsis (treated or untreated)
  • Subject with an immunosuppressive disorder
  • Subject has presence of malignant tumor, metastatic, or neoplastic disease
  • Subject has conditions that may interfere with the TKA survival or outcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease)
  • Subject has had intra-articular corticosteroid therapy (or any other intra-articular therapy) in the study knee within 3 months of study enrollment
  • Subject has inadequate bone stock to support the device and would require significant augmentation to correct the joint Female subject is of child-bearing age and unwilling to use an approved method of contraception
  • Subject has an emotional or neurological condition that would pre-empt their ability or willingness to comply with the study
  • Subject is severely overweight (BMI>40)
  • Subject is currently enrolled in another investigational drug, biologic, or device study or has been treated with an investigational product in the past 30 days
  • Subject is facing current or impending incarceration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: LEGION OXINIUM femoral component
Device: LEGION OXINIUM
Investigational Group
Active Comparator: LEGION Cobalt Chrome femoral components
Device: LEGION Cobalt Chrome
Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major modified Lymphocyte Transformation Tests (Cobalt, Chromium and Nickel) measurements
Time Frame: 3,650 Days
Metal hypersensitivity will be concluded if at least one of these three measurements is statistically significant
3,650 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minor modified Lymphocyte Transformation Tests (Aluminum, Iron, Molybdenum, Vanadium and Zirconium)
Time Frame: 3,650 Days
changes in mean mLTTs serum concentration values from baseline to each subsequent assessment
3,650 Days
Changes in mean serum bio-markers from baseline to each subsequent assessment
Time Frame: 3,650 Days
3,650 Days
Skin lesion evaluation to measure hypersensitivity
Time Frame: 3,650 Days
3,650 Days
Revision of LEGION Revision Knee System for any reason at each post-surgical assessment
Time Frame: 3,650 Days
3,650 Days
Improves in mean 2011 Knee Society Score (2011 KSS) from baseline to each subsequent assessment
Time Frame: 3,650 Days
3,650 Days
Anteroposterior, lateral and skyline knee views are assessed by radiographs
Time Frame: 3,650 Days
3,650 Days
All adverse event reporting from surgery to 10 year post-surgery
Time Frame: 3,650 Days
3,650 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Smith & Nephew, Inc.

Investigators

  • Principal Investigator: Thomas Turgeon, MD, Orthopaedic Innovation Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

April 1, 2025

Study Completion (Anticipated)

April 1, 2025

Study Registration Dates

First Submitted

March 5, 2015

First Submitted That Met QC Criteria

April 6, 2015

First Posted (Estimate)

April 9, 2015

Study Record Updates

Last Update Posted (Estimate)

March 9, 2016

Last Update Submitted That Met QC Criteria

March 8, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-4050-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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