LEGION™ Revision Metal Hypersensitivity Study | NCT02412813

Studies
LEGION™ Revision Metal Hypersensitivity Study

NCT02412813

Sponsor

Smith & Nephew, Inc.

Status

Withdrawn

Last Update Posted

Mar 9, 2016Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Total Knee Replacement Revision

Interventions

LEGION OXINIUM
LEGION Cobalt Chrome

Countries

United States
Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Overhaul of Study Design

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Apr 2025Estimated

Completion Date

Apr 2025Estimated

First Submitted Date

Mar 5, 2015

First Submission Date that Met QC Criteria

Apr 6, 2015

First Posted Date

Apr 9, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 8, 2016

Last Update Posted Date

Mar 9, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
LEGION OXINIUM femoral component	Active Comparator		Device: LEGION OXINIUM
LEGION Cobalt Chrome femoral components	Active Comparator		Device: LEGION Cobalt Chrome

Name	Type	Description	Arm Group Labels	Other Names
LEGION OXINIUM	Device	Investigational Group	LEGION OXINIUM femoral component

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	3,650 Days

Secondary Outcomes

Measure	Description	Time Frame
Minor modified Lymphocyte Transformation Tests (Aluminum, Iron, Molybdenum, Vanadium and Zirconium)	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Rothman Institute		Egg Harbor	New Jersey	08234	United States
Columbia University Medical Center