A Clinical Investigation of the Balance® Microplasty™ Hip System

Condition(s) targeted: Osteoarthritis, Hip; Rheumatoid Arthritis; Avascular Necrosis

Phase: N/A

Status: Active, not recruiting

Sponsored by: Biomet Orthopedics, Inc.

Official(s) and/or principal investigator(s):
Kenneth J Beres, MD, Study Director, Affiliation: Director, Clinical Research, Biomet Orthopedics, Inc.

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

Official title: A Prospective, Non-Controlled, Clinical Investigation of the Balance® Microplasty™ Hip System

Study design: Cohort, Prospective

Primary outcome:

Harris Hip Score

X-rays

Secondary outcome: Incidence of revisions and removals

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Starting date: January 2005
Ending date: December 2013
Last updated: June 13, 2008