Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Shell Using Simplex® or Palacos® Bone Cement
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...
Brief Summary
Official Title: “Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Acetabular Shell Using Simplex® or Palacos® Bone Cement”
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.
- Study Type: Interventional
- Study Design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: May 2010
Detailed Clinical Trial 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.Intervention(s) in this Clinical Trial
- Device: Answer® hip stem
- Total hip replacement using Palacos® bone cement, the Answer® hip stem and the Ranawat/Burnstein® acetabular shell.
- Device: Answer® hip stem
- Total hip replacement using Simplex® bone cement, the Answer® hip stem and the Ranawat/Burnstein® acetabular shell.
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: Answer Stem with Simplex Cement
- Active Comparator: Answer Stem with Palacos Cement
Outcome Measures for this Clinical Trial
Primary Measures
- Harris Hip Score
- Time Frame: 10 Years Post-Operative
Safety Issue?: No
- Time Frame: 10 Years Post-Operative
Secondary Measures
- Harris Hip Score Pain
- Time Frame: Pre-Operative, 6 months, 1 year, 2 year, 4 year, 6 year, 8 year, 10 year
Safety Issue?: No
- Time Frame: Pre-Operative, 6 months, 1 year, 2 year, 4 year, 6 year, 8 year, 10 year
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Biomet Orthopedics, LLC Industry
Overall Clinical Trial Officials and Contacts
Ken Beres, MD Study Director Biomet, Inc.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00588861
Study ID Number: 101-U-011
ClinicalTrials.gov Identifier: NCT00588861
Health Authority: United States: Institutional Review Board
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00588861
