Cementless Alumina-Alumina Total Hip and Hybrid

NCT ID: NCT00764530

Last Updated: 2017-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 342 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-11-30
• Study Completion Date: 2015-01-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Investigational

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

Group Type: EXPERIMENTAL

Alumina/Alumina

Intervention Type: DEVICE

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

Control Device

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

Group Type: ACTIVE_COMPARATOR

Standard

Intervention Type: DEVICE

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

Interventions

Alumina/Alumina

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

Intervention Type: DEVICE

Standard

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Encore Medical, L.P.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mark Newman, Inc.

Newport Beach, California, United States

Charleston Orthopaedic Assoc.

Charleston, South Carolina, United States

Advanced Orthopaedic Centers

Richmond, Virginia, United States

Countries

United States

Related Links

http://www.djosurgical.com

Sponsor company home page

Other Identifiers

Study 100

Identifier Type: -

Identifier Source: org_study_id