A Clinical Investigation of the Balance® Microplasty™ Hip System

A Prospective, Non-controlled, Clinical Investigation of the Balance® Microplasty™ Hip System

The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Balance® Microplasty™ Hip System.

Inclusion Criteria:

• 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.
• Revision of previously failed femoral head resurfacing component

Exclusion Criteria:

Absolute contraindications include:

• infection,
• sepsis,
• osteomyelitis.

Relative contraindications include:

• uncooperative patient or patient with neurologic disorders who are incapable of following directions,
• osteoporosis,
• metabolic disorders which may impair bone formation,
• osteomalacia,
• distant foci of infections which may spread to the implant site,
• rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram,
• vascular insufficiency, muscular atrophy, or neuromuscular disease.