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A Clinical Investigation of the Balance® Microplasty™ Hip System

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ClinicalTrials.gov Identifier: NCT00699088
Recruitment Status : Completed
First Posted : June 17, 2008
Last Update Posted : June 21, 2017
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet ( Biomet Orthopedics, LLC )

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Balance® Microplasty™ Hip System.

Condition or disease
Osteoarthritis, Hip Rheumatoid Arthritis Avascular Necrosis

Study Design
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Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Non-controlled, Clinical Investigation of the Balance® Microplasty™ Hip System
Study Start Date : January 2005
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Balance® Microplasty™ Hip System


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Harris Hip Score [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Incidence of revisions and removals [ Time Frame: 5 Years ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Biomet Orthopedics, LLC
ClinicalTrials.gov Identifier: NCT00699088     History of Changes
Other Study ID Numbers: Biomet 13594-117
First Posted: June 17, 2008    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: June 2017

Keywords provided by Zimmer Biomet ( Biomet Orthopedics, LLC ):
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