Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

A Clinical Investigation of the Balance® Microplasty™ Hip System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier:
NCT00699088
First received: June 13, 2008
Last updated: March 19, 2013
Last verified: March 2013
History of Changes
  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: 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:

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 ]
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)
Groups/Cohorts
Balance® Microplasty™ Hip System

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Russell Schenck, PhD Director, Clinical Research, Biomet Orthopedics, LLC
  More Information

Responsible Party: 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
Microplasty

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

ClinicalTrials.gov processed this record on September 30, 2016