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OpenTrials
Completed

NCT Number: NCT00764530

Cementless Alumina-Alumina Total Hip and Hybrid

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mark Newman, Inc., Newport Beach, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alumina/Alumina

Device

CeramTec Acetabular Alumina Insert and CeramTec Alumina head used with Foundation Porous Coated Acetabular Shell

Standard

Device

Foundation Porous Coated Acetabular Shell with Polyethylene Insert with the CeramTec Alumina head

Primary outcomes

  1. Alumina/Alumina articulation will perform as well as the alumina/polyethylene.

    Time frame: 5 year

Sponsors and collaborators

Lead sponsor

Encore Medical, L.P.

Industry

Registry information

Official study title

Keramos Ceramic/Ceramic Total Hip System

Important dates

Study start
2003
Primary completion
2015
Study completion
2015
First posted
Oct 2, 2008
Registry last updated
Jul 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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