Official Title: “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.

Study Type: Observational

Study Design: Cohort, Prospective

Study Primary Completion Date: December 2013

Arms, Groups and Cohorts in this Clinical Trial

• : Balance® Microplasty™ Hip System

Primary Measures

• Harris Hip Score
  • Time Frame: 6 weeks, 6 months, 1 year, 3 years, 5 years
    Safety Issue?: No
• X-rays
  • Time Frame: 6 weeks, 1 year, 3 years, 5 years
    Safety Issue?: No

Secondary Measures

• Incidence of revisions and removals
  • Time Frame: Any time
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Biomet Orthopedics, LLC

Overall Clinical Trial Officials and Contacts

Kenneth J Beres, MD Study Director Director, Clinical Research, Biomet Orthopedics, LLC  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00699088

Study ID Number: Biomet 13594-117

ClinicalTrials.gov Identifier: NCT00699088

Health Authority: United States: Institutional Review Board