Cementless Alumina-Alumina Total Hip and Hybrid

Encore Medical

Status: Completed

Conditions: Osteoarthritis; Avascular Necrosis; Post-traumatic Arthritis; Rheumatoid Arthritis

Treatments: Device: Standard; Device: Alumina/Alumina

Study type: Interventional

Funder types: Industry

Identifiers

NCT00764530

Study 100

Details and patient eligibility

About

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.

Enrollment: 342 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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342 participants in 2 patient groups

Investigational

Experimental group

Description:

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

Treatment:

Device: Alumina/Alumina

Control Device

Active Comparator group

Description:

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

Treatment:

Device: Standard