A Clinical Investigation of the Balance® Microplasty™ Hip System

Completed

• Conditions: Osteoarthritis, Hip; Rheumatoid Arthritis; Avascular Necrosis

• Registration Number: NCT00699088
• Lead Sponsor: Biomet Orthopedics, LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2008-06-13
• Study First Submitted QC: 2008-06-13
• Study First Posted: 2008-06-17
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-19
• Last Update Posted: 2017-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Harris Hip Score	5 years

Secondary Outcome Measures

Name	Time	Method
Incidence of revisions and removals	5 Years

Trial Locations

Locations (4)

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Orthopedic Specialty Clinic; 🇺🇸 Fredericksburg, Virginia, United States

Orthopaedic & Sports Medicine Clinic of Monroe; 🇺🇸 Monroe, Wisconsin, United States

Allegheny Health- Orthopedic Division; 🇺🇸 Pittsburgh, Pennsylvania, United States