Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Shell Using Simplex® or Palacos® Bone Cement

This study has been terminated.
(Study was terminated due to insufficient data and lack of patient follow-up)
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier:
NCT00588861
First received: December 19, 2007
Last updated: January 12, 2012
Last verified: January 2012

December 19, 2007
January 12, 2012
September 2002
May 2010   (final data collection date for primary outcome measure)
Harris Hip Score [ Time Frame: 10 Years Post-Operative ] [ Designated as safety issue: No ]
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."
Clinical outcomes including Harris Hip Score [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00588861 on ClinicalTrials.gov Archive Site
Harris Hip Score Pain [ Time Frame: Pre-Operative, 6 months, 1 year, 2 year, 4 year, 6 year, 8 year, 10 year ] [ Designated as safety issue: No ]
Harris Hip Score Pain is detailed below as mean score for the Harris Hip Score Pain question. 44 being the highest score, and 0 being the lowest score. 44 is considered "None/Ignores." 40 is considered "Slight/Occasional." 30 is considered "Mild." 20 is considered "Moderate." 10 is considered "Marked." 0 is considered "Totally Disabled."
Not Provided
Not Provided
Not Provided
 
Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Shell Using Simplex® or Palacos® Bone Cement
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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Osteoarthritis, Hip
  • Traumatic Arthritis of Hip
  • Device: Answer® hip stem
    Total hip replacement using Palacos® bone cement, the Answer® hip stem and the Ranawat/Burnstein® acetabular shell.
    Other Names:
    • Answer Hip Stem
    • Simplex Bone Cement
  • Device: Answer® hip stem
    Total hip replacement using Simplex® bone cement, the Answer® hip stem and the Ranawat/Burnstein® acetabular shell.
    Other Names:
    • Answer Hip Stem
    • Palacos Bone Cement
  • Active Comparator: Answer Stem with Simplex Cement
    Intervention: Device: Answer® hip stem
  • Active Comparator: Answer Stem with Palacos Cement
    Intervention: Device: Answer® hip stem
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
400
May 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00588861
101-U-011
No
Biomet, Inc. ( Biomet Orthopedics, LLC )
Biomet Orthopedics, LLC
Not Provided
Study Director: Ken Beres, MD Biomet, Inc.
Biomet, Inc.
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP