Back to resultsLEGION™ Revision Metal Hypersensitivity Study
Primary Purpose
Total Knee Replacement Revision
Status
Withdrawn
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
LEGION OXINIUM
LEGION Cobalt Chrome
Sponsored by
About this trial
This is an interventional treatment trial for Total Knee Replacement Revision focused on measuring hypersensitivity, metal sensitivity, arthroplasty, implant-related hypersensitivity, metal-on-metal implants, knee revision
Eligibility Criteria
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
Sites / Locations
- Rothman Institute
- Columbia University Medical Center
- Orthopaedic Innovation Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
LEGION OXINIUM femoral component
LEGION Cobalt Chrome femoral components
Arm Description
Outcomes
Primary Outcome Measures
Major modified Lymphocyte Transformation Tests (Cobalt, Chromium and Nickel) measurements
Metal hypersensitivity will be concluded if at least one of these three measurements is statistically significant
Secondary Outcome Measures
Minor modified Lymphocyte Transformation Tests (Aluminum, Iron, Molybdenum, Vanadium and Zirconium)
changes in mean mLTTs serum concentration values from baseline to each subsequent assessment
Changes in mean serum bio-markers from baseline to each subsequent assessment
Skin lesion evaluation to measure hypersensitivity
Revision of LEGION Revision Knee System for any reason at each post-surgical assessment
Improves in mean 2011 Knee Society Score (2011 KSS) from baseline to each subsequent assessment
Anteroposterior, lateral and skyline knee views are assessed by radiographs
All adverse event reporting from surgery to 10 year post-surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02412813
Brief Title
LEGION™ Revision Metal Hypersensitivity Study
Official Title
A Prospective, Randomized, Multi-Center, Metal Hypersensitivity Study Comparing OXINIUM and Cobalt Chrome Femoral Components in Failed Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Overhaul of Study Design
Study Start Date
January 2016 (undefined)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Smith & Nephew, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Knee Replacement Revision
Keywords
hypersensitivity, metal sensitivity, arthroplasty, implant-related hypersensitivity, metal-on-metal implants, knee revision
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LEGION OXINIUM femoral component
Arm Type
Active Comparator
Arm Title
LEGION Cobalt Chrome femoral components
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
LEGION OXINIUM
Intervention Description
Investigational Group
Intervention Type
Device
Intervention Name(s)
LEGION Cobalt Chrome
Intervention Description
Control Group
Primary Outcome Measure Information:
Title
Major modified Lymphocyte Transformation Tests (Cobalt, Chromium and Nickel) measurements
Description
Metal hypersensitivity will be concluded if at least one of these three measurements is statistically significant
Time Frame
3,650 Days
Secondary Outcome Measure Information:
Title
Minor modified Lymphocyte Transformation Tests (Aluminum, Iron, Molybdenum, Vanadium and Zirconium)
Description
changes in mean mLTTs serum concentration values from baseline to each subsequent assessment
Time Frame
3,650 Days
Title
Changes in mean serum bio-markers from baseline to each subsequent assessment
Time Frame
3,650 Days
Title
Skin lesion evaluation to measure hypersensitivity
Time Frame
3,650 Days
Title
Revision of LEGION Revision Knee System for any reason at each post-surgical assessment
Time Frame
3,650 Days
Title
Improves in mean 2011 Knee Society Score (2011 KSS) from baseline to each subsequent assessment
Time Frame
3,650 Days
Title
Anteroposterior, lateral and skyline knee views are assessed by radiographs
Time Frame
3,650 Days
Title
All adverse event reporting from surgery to 10 year post-surgery
Time Frame
3,650 Days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Turgeon, MD
Organizational Affiliation
Orthopaedic Innovation Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rothman Institute
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10038
Country
United States
Facility Name
Orthopaedic Innovation Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2K2M9
Country
Canada
12. IPD Sharing Statement
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LEGION™ Revision Metal Hypersensitivity Study
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