Biomet G7 Dual Mobility Ions

Principal Investigator: JeremyGililland
Keywords: Total Hip Replacement , Metal Ion Levels , Dual Mobility , Dislocation Department: Orthopedic Surgery
IRB Number: 00089804 Co Investigator: ChristopherPeters
Specialty: Orthopaedic Surgery
Sub Specialties: Adult Reconstruction

Contact Information

MichaelAnderson
mike.anderson@hsc.utah.edu
801-213-3442

Brief Summary

The primary purpose of this study is to assess the metal interface effect of the G7 Dual Mobility Construct (with the extra cobalt chromium liner) by tracking the metal ions level present in the blood serum. In addition, patient reported and radiographic outcomes, and complications of revision hip replacement, or high-risk primary hip replacement, will be collected.

Inclusion Criteria

Participants will be considered to be included in this trial if they satisfy all of the following criteria:

  • Patient receiving or having received (as described) a primary (Arm 1) or revision(Arm 2) total hip replacement using the G7 construct with either the PPS (Arm 1) or OsseoTi (Arm 2) acetabular cups.

 

Meet the cleared indications for use:

  • Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis
  • Rheumatoid arthritis
  • Correction of functional deformity
  • Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
  • Dislocation risks

Exclusion Criteria

Participants will be excluded from this trial if they satisfy any of the following criteria that match the package labeling for contraindications:

Contraindicated for use in individuals with:

  1. Infection
  2. Sepsis
  3. Osteomyelitis
  4. have ever lived within 5 miles of an industrial zone,  landfill or hazard waste site
  5. eat more than three servings of seafood/shellfish per week
  6. take dietary supplements containing chromium picolinate
  7. has been exposed to asbestos

 

Relative contraindications include:

  1. Uncooperative patient or patient with neurologic disorders who is incapable of following directions or complying with the protocol
  2. Osteoporosis
  3. Metabolic disorders which may impair bone formation,
  4. Osteomalacia
  5. Distant foci of infections which may spread to the implant site
  6. Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
  7. Vascular insufficiency, muscular atrophy, neuromuscular disease