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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Rheumatoid Arthritis; Avascular Necrosis; Post-traumatic Arthritis
• Intervention / Treatment: Device: Alumina/Alumina; Device: Standard

• Study Type: Interventional
• Enrollment (Actual): 342
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92663
      • Mark Newman, Inc.
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Charleston Orthopaedic Assoc.
  • Virginia
    • Richmond, Virginia, United States, 23294
      • Advanced Orthopaedic Centers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Alumina/Alumina articulation will perform as well as the alumina/polyethylene.	5 year

Collaborators and Investigators

• Sponsor: Encore Medical, L.P.

Publications and helpful links

Helpful Links

• Sponsor company home page

Study record dates

Study Major Dates

• Study Start: November 1, 2003
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: September 30, 2008
• First Submitted That Met QC Criteria: October 1, 2008
• First Posted (Estimate): October 2, 2008

Study Record Updates

• Last Update Posted (Actual): July 28, 2017
• Last Update Submitted That Met QC Criteria: July 26, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Joint Diseases; Musculoskeletal Diseases; Arthritis; Necrosis
• Other Study ID Numbers: Study 100