Avascular Necrosis, Osteoarthritis, Hip, Rheumatoid Arthritis
Conditions
Keywords
Total Hip Arthroplasty, Total Hip Replacement, Minimally Invasive, Microplasty
Brief summary
The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Balance® Microplasty™ Hip System.
Interventions
None listed
Sponsors
Biomet Orthopedics, LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Harris Hip Score | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of revisions and removals | 5 Years |
Countries
United States
Outcome results
None listed