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Cementless Alumina-Alumina Total Hip and Hybrid

Primary Purpose

Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alumina/Alumina
Standard
Sponsored by
Encore Medical, L.P.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with inflammatory tissue disorders (e.g. rheumatoid arthritis, lupus, etc), osteoarthritis, post-traumatic arthritis or secondary arthritis, or avascular necrosis.
  • Less than 70 on preoperative HHS score
  • Primary total hip replacement
  • Patient is likely to be available for evaluation for the duration of the study.

Exclusion Criteria:

  • Patients with physical conditions that would eliminate adequate implant support or prevent the use of an appropriately sized implant (e.g., tumor)
  • Previous surgery that has adversely affected bone stock (such as some hip pinning or some osteotomies) or prior total hip replacement.
  • Insufficient quality or quantity of bone resulting from conditions such as:

    • Cancer, where radiation has destroyed the available bonestock
    • Congenital dislocation
    • Metabolic bone disease of the upper femur or pelvis
    • Femoral osteotomy revision
    • Girdlestone revision
    • Active infection of the hip joint
    • Old or remote infection
    • Other conditions that lead to inadequate skeletal fixation
  • Neurological conditions that might hinder patient's ability to follow study procedures, e.g., to restrict physical activities (e.g., Severe Parkinson's, CVA on affected side)
  • Patient's mental condition that may interfere with his ability to give an informed consent or willingness to fulfill the required follow-up of the study

    • Mental illness
    • Senility
    • Drug Abuse
    • Alcoholism
  • Conditions that place excessive demands on the implant

    • Charcot's joints
    • Muscle deficiencies
    • Multiple joint disabilities
    • Refusal to modify postoperative physical activities
    • Skeletal immaturity
    • Obesity (50% over recorded body weight mass index)
  • Greater than or equal to 70 on preoperative HHS score

Sites / Locations

  • Mark Newman, Inc.
  • Charleston Orthopaedic Assoc.
  • Advanced Orthopaedic Centers

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Investigational

Control Device

Arm Description

CeramTec Acetabular Alumina Insert and CeramTec Alumina head used with Foundation Porous Coated Acetabular Shell.

Foundation Porous Coated Acetabular Shell with Polyethylene Insert with the CeramTec Alumina head.

Outcomes

Primary Outcome Measures

Alumina/Alumina articulation will perform as well as the alumina/polyethylene.

Secondary Outcome Measures

Full Information

First Posted
September 30, 2008
Last Updated
July 26, 2017
Sponsor
Encore Medical, L.P.
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1. Study Identification

Unique Protocol Identification Number
NCT00764530
Brief Title
Cementless Alumina-Alumina Total Hip and Hybrid
Official Title
Keramos Ceramic/Ceramic Total Hip System
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Encore Medical, L.P.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Evaluate the safety and efficacy of the CeramTec Acetabular Alumina Insert and CeramTec Alumina head when used with the Foundation Porous Coated Acetabular Shell and an Encore hip stem.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis, Avascular Necrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
342 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Investigational
Arm Type
Experimental
Arm Description
CeramTec Acetabular Alumina Insert and CeramTec Alumina head used with Foundation Porous Coated Acetabular Shell.
Arm Title
Control Device
Arm Type
Active Comparator
Arm Description
Foundation Porous Coated Acetabular Shell with Polyethylene Insert with the CeramTec Alumina head.
Intervention Type
Device
Intervention Name(s)
Alumina/Alumina
Intervention Description
CeramTec Acetabular Alumina Insert and CeramTec Alumina head used with Foundation Porous Coated Acetabular Shell
Intervention Type
Device
Intervention Name(s)
Standard
Intervention Description
Foundation Porous Coated Acetabular Shell with Polyethylene Insert with the CeramTec Alumina head
Primary Outcome Measure Information:
Title
Alumina/Alumina articulation will perform as well as the alumina/polyethylene.
Time Frame
5 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with inflammatory tissue disorders (e.g. rheumatoid arthritis, lupus, etc), osteoarthritis, post-traumatic arthritis or secondary arthritis, or avascular necrosis. Less than 70 on preoperative HHS score Primary total hip replacement Patient is likely to be available for evaluation for the duration of the study. Exclusion Criteria: Patients with physical conditions that would eliminate adequate implant support or prevent the use of an appropriately sized implant (e.g., tumor) Previous surgery that has adversely affected bone stock (such as some hip pinning or some osteotomies) or prior total hip replacement. Insufficient quality or quantity of bone resulting from conditions such as: Cancer, where radiation has destroyed the available bonestock Congenital dislocation Metabolic bone disease of the upper femur or pelvis Femoral osteotomy revision Girdlestone revision Active infection of the hip joint Old or remote infection Other conditions that lead to inadequate skeletal fixation Neurological conditions that might hinder patient's ability to follow study procedures, e.g., to restrict physical activities (e.g., Severe Parkinson's, CVA on affected side) Patient's mental condition that may interfere with his ability to give an informed consent or willingness to fulfill the required follow-up of the study Mental illness Senility Drug Abuse Alcoholism Conditions that place excessive demands on the implant Charcot's joints Muscle deficiencies Multiple joint disabilities Refusal to modify postoperative physical activities Skeletal immaturity Obesity (50% over recorded body weight mass index) Greater than or equal to 70 on preoperative HHS score
Facility Information:
Facility Name
Mark Newman, Inc.
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Charleston Orthopaedic Assoc.
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Advanced Orthopaedic Centers
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.djosurgical.com
Description
Sponsor company home page

Learn more about this trial

Cementless Alumina-Alumina Total Hip and Hybrid

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