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Status:

COMPLETED

Cementless Alumina-Alumina Total Hip and Hybrid

Lead Sponsor:

Encore Medical, L.P.

Conditions:

Rheumatoid Arthritis

Osteoarthritis

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

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.

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

November 1 2003

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2015

Estimated Enrollment :

342 Patients enrolled

Trial Details

Trial ID

NCT00764530

Start Date

November 1 2003

End Date

January 1 2015

Last Update

July 28 2017

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Mark Newman, Inc.

Newport Beach, California, United States, 92663

2

Charleston Orthopaedic Assoc.

Charleston, South Carolina, United States, 29414

3

Advanced Orthopaedic Centers

Richmond, Virginia, United States, 23294