Status:
COMPLETED
A Clinical Investigation of the Balance® Microplasty™ Hip System
Lead Sponsor:
Biomet Orthopedics, LLC
Conditions:
Osteoarthritis, Hip
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Balance® Microplasty™ Hip System.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00699088
Start Date
January 1 2005
End Date
March 1 2013
Last Update
June 21 2017
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Chicago
Chicago, Illinois, United States, 60640
2
Allegheny Health- Orthopedic Division
Pittsburgh, Pennsylvania, United States, 15212
3
Orthopedic Specialty Clinic
Fredericksburg, Virginia, United States, 22401
4
Orthopaedic & Sports Medicine Clinic of Monroe
Monroe, Wisconsin, United States, 53566