A Clinical Investigation of the Balance® Microplasty™ Hip System
This study has been completed.
Sponsor:
Biomet Orthopedics, LLC
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
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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:
Genetics Home Reference related topics:
rheumatoid arthritis
MedlinePlus related topics:
Osteoarthritis
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 |
| 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
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
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 Microplasty |
Additional relevant MeSH terms:
|
Arthritis, Rheumatoid Osteoarthritis, Hip Arthritis Autoimmune Diseases Connective Tissue Diseases |
Immune System Diseases Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases |
ClinicalTrials.gov processed this record on February 27, 2015