A Clinical Investigation of the Balance® Microplasty™ Hip System

Zimmer Biomet

Status: Completed

Conditions: Osteoarthritis, Hip; Avascular Necrosis; Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT00699088

Biomet 13594-117

Details and patient eligibility

About

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

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

70 participants in 1 patient group

Balance® Microplasty™ Hip System