Cementless Alumina-Alumina Total Hip and Hybrid

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Encore Medical, L.P.
ClinicalTrials.gov Identifier:
NCT00764530
First received: September 30, 2008
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Osteoarthritis
Post-traumatic Arthritis
Avascular Necrosis
Device: Alumina/Alumina
Device: Standard
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Keramos Ceramic/Ceramic Total Hip System

Resource links provided by NLM:


Further study details as provided by Encore Medical, L.P.:

Primary Outcome Measures:
  • Alumina/Alumina articulation will perform as well as the alumina/polyethylene. [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]

Enrollment: 342
Study Start Date: November 2003
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Investigational
CeramTec Acetabular Alumina Insert and CeramTec Alumina head used with Foundation Porous Coated Acetabular Shell.
Device: Alumina/Alumina
CeramTec Acetabular Alumina Insert and CeramTec Alumina head used with Foundation Porous Coated Acetabular Shell
Active Comparator: Control Device
Foundation Porous Coated Acetabular Shell with Polyethylene Insert with the CeramTec Alumina head.
Device: Standard
Foundation Porous Coated Acetabular Shell with Polyethylene Insert with the CeramTec Alumina head

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00764530

Locations
United States, California
Mark Newman, Inc.
Newport Beach, California, United States, 92663
United States, South Carolina
Charleston Orthopaedic Assoc.
Charleston, South Carolina, United States, 29414
United States, Virginia
Advanced Orthopaedic Centers
Richmond, Virginia, United States, 23294
Sponsors and Collaborators
Encore Medical, L.P.
  More Information

Additional Information:
No publications provided

Responsible Party: Encore Medical, L.P.
ClinicalTrials.gov Identifier: NCT00764530     History of Changes
Other Study ID Numbers: Study 100
Study First Received: September 30, 2008
Last Updated: February 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Osteoarthritis
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 29, 2014