Cementless Alumina-Alumina Total Hip and Hybrid

Rheumatoid Arthritis Clinical Trial

Official title:

Keramos Ceramic/Ceramic Total Hip System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00764530
• Other study ID #: Study 100
• Status: Completed
• Phase: N/A
• First received: September 30, 2008
• Last updated: July 26, 2017
• Start date: November 2003
• Est. completion date: January 2015

Study information

• Verified date: July 2017
• Source: Encore Medical, L.P.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 342
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Avascular Necrosis
• Necrosis
• Osteoarthritis
• Post-traumatic Arthritis
• Rheumatoid Arthritis

Intervention

Device:
• Alumina/Alumina
CeramTec Acetabular Alumina Insert and CeramTec Alumina head used with Foundation Porous Coated Acetabular Shell
• Standard
Foundation Porous Coated Acetabular Shell with Polyethylene Insert with the CeramTec Alumina head

Locations

Country	Name	City	State
United States	Charleston Orthopaedic Assoc.	Charleston	South Carolina
United States	Mark Newman, Inc.	Newport Beach	California
United States	Advanced Orthopaedic Centers	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Encore Medical, L.P.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alumina/Alumina articulation will perform as well as the alumina/polyethylene.		5 year

External Links

•   Sponsor company home page