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

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ClinicalTrials.gov Identifier: NCT00588861
Recruitment Status : Terminated (Study was terminated due to insufficient data and lack of patient follow-up)
First Posted : January 9, 2008
Results First Posted : January 26, 2012
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet ( Biomet Orthopedics, LLC )

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Hip Traumatic Arthritis of Hip Device: Answer® hip stem Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Acetabular Shell Using Simplex® or Palacos® Bone Cement
Study Start Date : September 2002
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Answer® hip stem with Simplex Cement
Femoral stem replacement with Answer® hip stem & Simplex Bone Cement
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® hip stem with Palacos Cement
Femoral stem replacement with Answer® hip stem & Palacos Bone Cement
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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Harris Hip Score Pain [ Time Frame: Pre-Operative, 6 months, 1 year, 2 year, 4 year, 6 year, 8 year, 10 year ]
    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."



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00588861


Locations
United States, Indiana
Biomet Orthopedics, LLC
Warsaw, Indiana, United States, 46581
Sponsors and Collaborators
Biomet Orthopedics, LLC
Investigators
Study Director: Ken Beres, MD Zimmer Biomet

Responsible Party: Biomet Orthopedics, LLC
ClinicalTrials.gov Identifier: NCT00588861     History of Changes
Other Study ID Numbers: 101-U-011
First Posted: January 9, 2008    Key Record Dates
Results First Posted: January 26, 2012
Last Update Posted: January 27, 2017
Last Verified: January 2012

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases