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

Primary Purpose

Osteoarthritis, Hip, Traumatic Arthritis of Hip

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Answer® hip stem
Answer® hip stem
Sponsored by
Biomet Orthopedics, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Hip

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Biomet Orthopedics, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Answer® hip stem with Simplex Cement

Answer® hip stem with Palacos Cement

Arm Description

Femoral stem replacement with Answer® hip stem & Simplex Bone Cement

Femoral stem replacement with Answer® hip stem & Palacos Bone Cement

Outcomes

Primary Outcome Measures

Harris Hip Score
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

Harris Hip Score Pain
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."

Full Information

First Posted
December 19, 2007
Last Updated
January 26, 2017
Sponsor
Biomet Orthopedics, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00588861
Brief Title
Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Shell Using Simplex® or Palacos® Bone Cement
Official Title
Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Acetabular Shell Using Simplex® or Palacos® Bone Cement
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated due to insufficient data and lack of patient follow-up
Study Start Date
September 2002 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biomet Orthopedics, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip, Traumatic Arthritis of Hip

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Answer® hip stem with Simplex Cement
Arm Type
Active Comparator
Arm Description
Femoral stem replacement with Answer® hip stem & Simplex Bone Cement
Arm Title
Answer® hip stem with Palacos Cement
Arm Type
Active Comparator
Arm Description
Femoral stem replacement with Answer® hip stem & Palacos Bone Cement
Intervention Type
Device
Intervention Name(s)
Answer® hip stem
Other Intervention Name(s)
Answer Hip Stem, Simplex Bone Cement
Intervention Description
Total hip replacement using Palacos® bone cement, the Answer® hip stem and the Ranawat/Burnstein® acetabular shell.
Intervention Type
Device
Intervention Name(s)
Answer® hip stem
Other Intervention Name(s)
Answer Hip Stem, Palacos Bone Cement
Intervention Description
Total hip replacement using Simplex® bone cement, the Answer® hip stem and the Ranawat/Burnstein® acetabular shell.
Primary Outcome Measure Information:
Title
Harris Hip Score
Description
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."
Time Frame
10 Years Post-Operative
Secondary Outcome Measure Information:
Title
Harris Hip Score Pain
Description
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."
Time Frame
Pre-Operative, 6 months, 1 year, 2 year, 4 year, 6 year, 8 year, 10 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ken Beres, MD
Organizational Affiliation
Zimmer Biomet
Official's Role
Study Director
Facility Information:
Facility Name
Biomet Orthopedics, LLC
City
Warsaw
State/Province
Indiana
ZIP/Postal Code
46581
Country
United States

12. IPD Sharing Statement

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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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