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28 mm Ceramic-on-Ceramic Acetabular Cup Total Hip Replacement Study

Primary Purpose

Joint Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
28 mm ceramic head on ceramic acetabular liner.
28 mm ceramic head on polyethylene liner
Sponsored by
DePuy Orthopaedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Joint Diseases focused on measuring Joint Diseases, Non-Inflammatory Degenerative Joint Disease

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Non-inflammatory degenerative joint disease. Composite diagnoses of NIDJD include osteoarthritis, avascular necrosis, post-traumatic arthritis, slipped capital femoral epiphysis (SCFE), fracture of the pelvis, and developmental dysplasia. X-ray evaluation confirms the presence of NIDJD Femoral and acetabular bone stock is sufficient, regarding strength and shape, and is suitable to receive the implants. Individuals 20 to 75 years of age at the time of surgery Patients with a previous total hip replacement of the contralateral leg who have a pain rating of none or slight and who are at least one year post arthroplasty are eligible for participation in the study. Harris Hip Score of 70 or lower Pain at least Moderate Exclusion Criteria: Presence of a previous prosthetic hip replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.) in the hip joint to be operated. Previous Girdlestone procedure (resection arthroplasty) or surgical fusion of the hip to be operated. Acute femoral neck fracture. Above knee amputation of the contralateral and/or ipsilateral leg. Patients with bilateral degenerative joint disease requiring staged or simultaneous hip replacements. Patients with an existing total hip arthroplasty in the contralateral hip with a Harris Hip pain rating of mild, moderate, marked or totally disabled. Patients who have undergone total hip arthroplasties in their contralateral hips within the past 12 months. Patients with a known allergy to metal (e.g. jewelry). Skeletally immature patients (tibial and femoral epiphyses are not closed). Evidence of active infections that may spread to other areas of the body (e.g., osteomyelitis, pyogenic infection of the hip joint, overt infection, urinary tract infection, etc.). The presence of highly communicable disease or diseases that may limit follow-up (e.g., immuno-compromised conditions, hepatitis, active tuberculosis, etc.). Presence of known metastatic or neoplastic disease. Significant neurologic or musculoskeletal disorders or disease that may adversely affect gait or weight bearing, (e.g., muscular dystrophy, multiple sclerosis). Conditions that may interfere with the total hip arthroplasty's survival or outcome, (e.g., Paget's disease, Charcot's disease). Any patient believed to be unwilling or unable to comply with a rehabilitation program for a cementless total hip replacement or who indicates difficulty or inability to return for follow-up visits prescribed by the study protocol. Patient is known to be pregnant, a prisoner, mentally incompetent, and/or alcohol or drug abuser. Any systemic steroid therapy, excluding inhalers, within three months prior to surgery. Patients carrying the diagnosis of inflammatory degenerative arthritis (IDJD) to include the following composite diagnoses: rheumatoid arthritis, systemic lupus erythematosus, pigmented villonodular synovitis, juvenile rheumatory arthritis and other arthritic processes of inflammatory or autoimmune etiology. Patients requiring structural bone grafts in order to support the prosthetic component(s) or to shape the bone to receive the implant(s). Patients who refuse to provide consent to participate in the clinical investigation.

Sites / Locations

  • Colorado Joint Replacement
  • Cardinal Orthopaedic Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Delta Ceramax Ceramic-on-Ceramic Acetabular Cup System

Pinnacle™ Acetabular Cup with Marathon® Polyethylene

Arm Description

Total hip replacement with a 28 mm ceramic head and liner.

Total hip replacement with 28 mm ceramic head with a polyethylene liner.

Outcomes

Primary Outcome Measures

Harris Hip Total Score
The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon. A score of 91-100 is excellent, 81-90 is good, 71-80 is fair, 70 or below is poor. The patient records the following: pain level, need for assistance when walking, presence of a limp, distance able to walk, ability to put on shoes and socks, climb stairs, use public transportation and the length of time one is able to comfortably sit in a chair are all scored.

Secondary Outcome Measures

Complication Rates

Full Information

First Posted
September 13, 2005
Last Updated
December 18, 2013
Sponsor
DePuy Orthopaedics
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1. Study Identification

Unique Protocol Identification Number
NCT00208507
Brief Title
28 mm Ceramic-on-Ceramic Acetabular Cup Total Hip Replacement Study
Official Title
Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prosthesis Study (28mm)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DePuy Orthopaedics

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study is designed to evaluate artificial hips with a 28 mm ceramic head and a ceramic liner to determine whether they perform as well as artificial hips with a 28 mm ceramic head and a polyethylene liner.
Detailed Description
Total Hip Arthroplasty (THA) is the surgical reconstruction of the hip joint through replacement of the femoral head and the acetabular articulating surfaces with fixed prosthetic devices. The goals of THA are relief from pain, restoration of function, and correction of deformity. THA is one of the most common adult reconstructive procedures. Over the past 25 years, patients who have needed to have their hip joint replaced, either due to trauma or arthritic disease, typically have had their hip joint bone articular surfaces replaced with a metal hip stem, metal ball head (either stainless steel or chrome cobalt) and a plastic acetabular cup (metal/metal/plastic). While the basic device has remained essentially unchanged over that period, technological advancements in implant designs and materials, and improvements in surgical technique and instrumentation have made THA one of the most durable and successful procedures in medicine. Reproducible, high-quality, short-term and mid-term results are attained regularly, and total hip replacements commonly last 10 to 15 years and longer. The success of this procedure has allowed its expansion into a wider, and often younger and more active population. In spite of the improvements in THA, little change has occurred for the acetabular cup liner, which is usually made out of Ultra High Molecular Weight Polyethylene plastic (UHMWPe). Because it is plastic and inherently soft and somewhat pliable under load, the cup's articular surface must inevitability wear and produce debris. This biologic response is now thought to be a significant contributor to prosthetic component loosening, a primary failure mode of THR. UHMWPe also degrades with time in the body. As concerns about polyethylene wear and the associated untoward effects of the generated wear debris, and as THA continues to be used in younger and higher-demand patients with increasing life expectancies, interest in ceramic on ceramic total hip prosthesis has been renewed. An alumina ceramic-on-ceramic acetabular coupling has been employed as an alternative to metal/polyethylene couplings. This ceramic-on-ceramic coupling has many advantages, including the elimination of polyethylene from the device system, wear rates that are appreciably less than those experienced with metal/polyethylene couplings and reduced biologic reactivity. The potential benefits of an alumina ceramic/ceramic bearing are significant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Joint Diseases
Keywords
Joint Diseases, Non-Inflammatory Degenerative Joint Disease

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Delta Ceramax Ceramic-on-Ceramic Acetabular Cup System
Arm Type
Active Comparator
Arm Description
Total hip replacement with a 28 mm ceramic head and liner.
Arm Title
Pinnacle™ Acetabular Cup with Marathon® Polyethylene
Arm Type
Active Comparator
Arm Description
Total hip replacement with 28 mm ceramic head with a polyethylene liner.
Intervention Type
Device
Intervention Name(s)
28 mm ceramic head on ceramic acetabular liner.
Other Intervention Name(s)
Delta Ceramax™ 28 mm Ceramic-on-Ceramic Acetabular Cup
Intervention Description
Total hip replacement with 28 mm ceramic head on ceramic liner articulation
Intervention Type
Device
Intervention Name(s)
28 mm ceramic head on polyethylene liner
Other Intervention Name(s)
Detla Ceramax 28 mm ceramic femoral head and Marathon polyethylene liner.
Intervention Description
Total hip replacement with 28 mm ceramic head on a polyethylene liner articulation.
Primary Outcome Measure Information:
Title
Harris Hip Total Score
Description
The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon. A score of 91-100 is excellent, 81-90 is good, 71-80 is fair, 70 or below is poor. The patient records the following: pain level, need for assistance when walking, presence of a limp, distance able to walk, ability to put on shoes and socks, climb stairs, use public transportation and the length of time one is able to comfortably sit in a chair are all scored.
Time Frame
6 weeks, 6, 12 months and last follow up at 24 months or greater
Secondary Outcome Measure Information:
Title
Complication Rates
Time Frame
On-going to end of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Non-inflammatory degenerative joint disease. Composite diagnoses of NIDJD include osteoarthritis, avascular necrosis, post-traumatic arthritis, slipped capital femoral epiphysis (SCFE), fracture of the pelvis, and developmental dysplasia. X-ray evaluation confirms the presence of NIDJD Femoral and acetabular bone stock is sufficient, regarding strength and shape, and is suitable to receive the implants. Individuals 20 to 75 years of age at the time of surgery Patients with a previous total hip replacement of the contralateral leg who have a pain rating of none or slight and who are at least one year post arthroplasty are eligible for participation in the study. Harris Hip Score of 70 or lower Pain at least Moderate Exclusion Criteria: Presence of a previous prosthetic hip replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.) in the hip joint to be operated. Previous Girdlestone procedure (resection arthroplasty) or surgical fusion of the hip to be operated. Acute femoral neck fracture. Above knee amputation of the contralateral and/or ipsilateral leg. Patients with bilateral degenerative joint disease requiring staged or simultaneous hip replacements. Patients with an existing total hip arthroplasty in the contralateral hip with a Harris Hip pain rating of mild, moderate, marked or totally disabled. Patients who have undergone total hip arthroplasties in their contralateral hips within the past 12 months. Patients with a known allergy to metal (e.g. jewelry). Skeletally immature patients (tibial and femoral epiphyses are not closed). Evidence of active infections that may spread to other areas of the body (e.g., osteomyelitis, pyogenic infection of the hip joint, overt infection, urinary tract infection, etc.). The presence of highly communicable disease or diseases that may limit follow-up (e.g., immuno-compromised conditions, hepatitis, active tuberculosis, etc.). Presence of known metastatic or neoplastic disease. Significant neurologic or musculoskeletal disorders or disease that may adversely affect gait or weight bearing, (e.g., muscular dystrophy, multiple sclerosis). Conditions that may interfere with the total hip arthroplasty's survival or outcome, (e.g., Paget's disease, Charcot's disease). Any patient believed to be unwilling or unable to comply with a rehabilitation program for a cementless total hip replacement or who indicates difficulty or inability to return for follow-up visits prescribed by the study protocol. Patient is known to be pregnant, a prisoner, mentally incompetent, and/or alcohol or drug abuser. Any systemic steroid therapy, excluding inhalers, within three months prior to surgery. Patients carrying the diagnosis of inflammatory degenerative arthritis (IDJD) to include the following composite diagnoses: rheumatoid arthritis, systemic lupus erythematosus, pigmented villonodular synovitis, juvenile rheumatory arthritis and other arthritic processes of inflammatory or autoimmune etiology. Patients requiring structural bone grafts in order to support the prosthetic component(s) or to shape the bone to receive the implant(s). Patients who refuse to provide consent to participate in the clinical investigation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Politi, MD
Organizational Affiliation
Cardinal Orthopaedic Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Douglas Dennis, MD
Organizational Affiliation
Colorado Joint Replacement
Official's Role
Principal Investigator
Facility Information:
Facility Name
Colorado Joint Replacement
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Cardinal Orthopaedic Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States

12. IPD Sharing Statement

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28 mm Ceramic-on-Ceramic Acetabular Cup Total Hip Replacement Study

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