Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Shell Using Simplex® or Palacos® Bone Cement
Information source: Biomet, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Degenerative Joint (Hip) Disease; Arthritis of the Hip Joint
Intervention: Answer® hip stem (Device); Answer® hip stem (Device)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Biomet Orthopedics, Inc.
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.
Clinical Details
Official title: Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Acetabular Shell Using Simplex® or Palacos® Bone Cement
Study design: Treatment, Non-Randomized, Open Label, Parallel Assignment
Primary outcome: Clinical outcomes including Harris Hip Score
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Biomet Orthopedics, Inc., Warsaw, Indiana 46581, United States
Additional Information
Starting date: September 2002
Ending date: September 2016
Last updated: January 2, 2008
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