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

September 30, 2008
February 4, 2014
November 2003
March 2014   (final data collection date for primary outcome measure)
Alumina/Alumina articulation will perform as well as the alumina/polyethylene. [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00764530 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Cementless Alumina-Alumina Total Hip and Hybrid
Keramos Ceramic/Ceramic Total Hip System

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Rheumatoid Arthritis
  • Osteoarthritis
  • Post-traumatic Arthritis
  • Avascular Necrosis
  • Device: Alumina/Alumina
    CeramTec Acetabular Alumina Insert and CeramTec Alumina head used with Foundation Porous Coated Acetabular Shell
  • Device: Standard
    Foundation Porous Coated Acetabular Shell with Polyethylene Insert with the CeramTec Alumina head
  • Experimental: Investigational
    CeramTec Acetabular Alumina Insert and CeramTec Alumina head used with Foundation Porous Coated Acetabular Shell.
    Intervention: Device: Alumina/Alumina
  • Active Comparator: Control Device
    Foundation Porous Coated Acetabular Shell with Polyethylene Insert with the CeramTec Alumina head.
    Intervention: Device: Standard
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
342
November 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00764530
Study 100
No
Encore Medical, L.P.
Encore Medical, L.P.
Not Provided
Not Provided
Encore Medical, L.P.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP