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
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
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
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
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
We'll reach out to this number within 24 hrs