Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Acetabular Shell Using Simplex® or Palacos® Bone Cement
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Osteoarthritis, Hip
- Sponsor
- Biomet Orthopedics, LLC
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Harris Hip Score
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to document the clinical outcomes of several devices used in total hip replacement, including the Answer® hip stem, the Ranawat/Burnstein® acetabular shell, and Simplex® or Palacos® bone cement.
Detailed Description
The purpose of this study is to document the clinical outcomes of several devices used in total hip replacement, including the Answer® hip stem, the Ranawat/Burnstein® acetabular shell, and Simplex® or Palacos® bone cement. It was desirable to see if there were any differences in the outcomes of two different types of bone cement in application.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Noninflammatory 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 using other techniques
Exclusion Criteria
- •Infection, sepsis, and osteomyelitis
Outcomes
Primary Outcomes
Harris Hip Score
Time Frame: 10 Years Post-Operative
The Harris Hip Score is detailed below as a range. 100 being the highest score, and 0 being the lowest score. 90-100 is considered "Excellent." 80-89 is considered "Good." 70-79 is considered "Fair." Less than 70 is considered "Poor."
Secondary Outcomes
- Harris Hip Score Pain(Pre-Operative, 6 months, 1 year, 2 year, 4 year, 6 year, 8 year, 10 year)