LEGION™ Revision Metal Hypersensitivity Study

Smith & Nephew

Status

Withdrawn

Conditions

Total Knee Replacement Revision

Treatments

Device: LEGION Cobalt Chrome

Device: LEGION OXINIUM

Study type

Interventional

Funder types

Industry

Identifiers

NCT02412813

13-4050-05

Details and patient eligibility

About

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).

Full 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.

Sex

All

Volunteers

No Healthy Volunteers

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