Cementless Alumina-Alumina Total Hip and Hybrid

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Encore Medical, L.P.

ClinicalTrials.gov Identifier:

NCT00764530

First received: September 30, 2008

Last updated: November 2, 2011

Last verified: November 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	September 30, 2008
Last Updated Date	November 2, 2011
Start Date ^ICMJE	November 2003
Estimated Primary Completion Date	March 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 1, 2008)	Alumina/Alumina articulation will perform as well as the alumina/polyethylene. [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00764530 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Cementless Alumina-Alumina Total Hip and Hybrid
Official Title ^ICMJE	Keramos Ceramic/Ceramic Total Hip System
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Condition ^ICMJE	Rheumatoid Arthritis Osteoarthritis Post-traumatic Arthritis Avascular Necrosis
Intervention ^ICMJE	Device: Alumina/Alumina CeramTec Acetabular Alumina Insert and CeramTec Alumina head used with Foundation Porous Coated Acetabular Shell Device: Standard Foundation Porous Coated Acetabular Shell with Polyethylene Insert with the CeramTec Alumina head
Study Arm (s)	Experimental: Investigational CeramTec Acetabular Alumina Insert and CeramTec Alumina head used with Foundation Porous Coated Acetabular Shell. Intervention: Device: Alumina/Alumina Active Comparator: Control Device Foundation Porous Coated Acetabular Shell with Polyethylene Insert with the CeramTec Alumina head. Intervention: Device: Standard
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	342
Estimated Completion Date	November 2014
Estimated Primary Completion Date	March 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00764530
Other Study ID Numbers ^ICMJE	Study 100
Has Data Monitoring Committee	No
Responsible Party	Encore Medical, L.P.
Study Sponsor ^ICMJE	Encore Medical, L.P.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Encore Medical, L.P.
Verification Date	November 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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