A Clinical Investigation of the Balance® Microplasty™ Hip System

This study has been completed.
Information provided by (Responsible Party):
Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier:
First received: June 13, 2008
Last updated: March 19, 2013
Last verified: March 2013

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

Osteoarthritis, Hip
Rheumatoid Arthritis
Avascular Necrosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Non-controlled, Clinical Investigation of the Balance® Microplasty™ Hip System

Resource links provided by NLM:

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Harris Hip Score [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of revisions and removals [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]

Enrollment: 70
Study Start Date: January 2005
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Balance® Microplasty™ Hip System


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients requiring relief from painful or disabling joint disease


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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00699088

United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60640
United States, Pennsylvania
Allegheny Health- Orthopedic Division
Pittsburgh, Pennsylvania, United States, 15212
United States, Virginia
Orthopedic Specialty Clinic
Fredericksburg, Virginia, United States, 22401
United States, Wisconsin
Orthopaedic & Sports Medicine Clinic of Monroe
Monroe, Wisconsin, United States, 53566
Sponsors and Collaborators
Biomet Orthopedics, LLC
Study Director: Russell Schenck, PhD Director, Clinical Research, Biomet Orthopedics, LLC
  More Information

No publications provided

Responsible Party: Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier: NCT00699088     History of Changes
Other Study ID Numbers: Biomet 13594-117
Study First Received: June 13, 2008
Last Updated: March 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Biomet, Inc.:
Total Hip Arthroplasty
Total Hip Replacement
Minimally Invasive

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Osteoarthritis, Hip
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Bone Diseases

ClinicalTrials.gov processed this record on April 15, 2014