Clinical trial NCT02412813: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Total Knee Replacement Revision
Keywords: hypersensitivity
metal sensitivity
arthroplasty
implant-related hypersensitivity
metal-on-metal implants
knee revision
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-09
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Major modified Lymphocyte Transformation Tests (Cobalt, Chromium and Nickel) measurements
timeFrame: 3,650 Days
Secondary outcomes:
measure: Minor modified Lymphocyte Transformation Tests (Aluminum, Iron, Molybdenum, Vanadium and Zirconium)
timeFrame: 3,650 Days
measure: Changes in mean serum bio-markers from baseline to each subsequent assessment
timeFrame: 3,650 Days
measure: Skin lesion evaluation to measure hypersensitivity
timeFrame: 3,650 Days
measure: Revision of LEGION Revision Knee System for any reason at each post-surgical assessment
timeFrame: 3,650 Days
measure: Improves in mean 2011 Knee Society Score (2011 KSS) from baseline to each subsequent assessment
timeFrame: 3,650 Days
measure: Anteroposterior, lateral and skyline knee views are assessed by radiographs
timeFrame: 3,650 Days
measure: All adverse event reporting from surgery to 10 year post-surgery
timeFrame: 3,650 Days
Other outcomes:
Locations:
city: Egg Harbor Township
country: United States
facility: Rothman Institute
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Winnipeg
country: Canada
facility: Orthopaedic Innovation Centre
state: Manitoba
Study officials:
affiliation: Orthopaedic Innovation Centre
name: Thomas Turgeon, MD
role: PRINCIPAL_INVESTIGATOR
References: