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
|
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Condition or disease |
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Osteoarthritis, Hip Rheumatoid Arthritis Avascular Necrosis |
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 |
Group/Cohort |
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Balance® Microplasty™ Hip System |
- Harris Hip Score [ Time Frame: 5 years ]
- Incidence of revisions and removals [ Time Frame: 5 Years ]

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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 |
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.

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
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 |
Study Director: | Russell Schenck, PhD | Director, Clinical Research, Biomet Orthopedics, LLC |
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 |