A Clinical Investigation of the Balance® Microplasty™ Hip System

This study is ongoing, but not recruiting participants.

First Received: June 13, 2008 Last Updated: December 7, 2009 History of Changes

Sponsor:	Biomet Orthopedics, LLC
Information provided by:	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00699088

Purpose

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

Condition
Osteoarthritis, Hip Rheumatoid Arthritis Avascular Necrosis

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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis Osteonecrosis Rheumatoid Arthritis

U.S. FDA Resources

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	70
Study Start Date:	January 2005
Estimated Study Completion Date:	June 2014
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts
Balance® Microplasty™ Hip System

Eligibility

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

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.

Contacts and Locations

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

Locations

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

Investigators

Study Director:

Kenneth J Beres, MD

Director, Clinical Research, Biomet Orthopedics, LLC

More Information

No publications provided

Responsible Party:	Biomet Orthopedics, LLC ( Kenneth Beres, MD Director Clinical Research )
Study ID Numbers:	Biomet 13594-117
Study First Received:	June 13, 2008
Last Updated:	December 7, 2009
ClinicalTrials.gov Identifier:	NCT00699088 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Biomet, Inc.:

Total Hip Arthroplasty
Total Hip Replacement
Minimally Invasive
Microplasty

Additional relevant MeSH terms:

Autoimmune Diseases
Osteonecrosis
Immune System Diseases
Osteoarthritis
Joint Diseases
Arthritis, Rheumatoid
Osteoarthritis, Hip

Rheumatic Diseases
Bone Diseases
Necrosis
Pathologic Processes
Musculoskeletal Diseases
Arthritis
Connective Tissue Diseases

ClinicalTrials.gov processed this record on February 08, 2010