Cementless Alumina-Alumina Total Hip and Hybrid

• Sponsor: Encore Medical, L.P. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00764530
• Collaborator: (none)
• Enrollment: 342
• Locations: 3
• Arms: 2
• Duration (Months): 134
• Patients Per Site: 114
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis; Osteoarthritis; Post-traumatic Arthritis; Avascular Necrosis	Device: Alumina/Alumina; Device: Standard	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 342 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Keramos Ceramic/Ceramic Total Hip System
• Study Start Date: Nov 1, 2003
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Investigational CeramTec Acetabular Alumina Insert and CeramTec Alumina head used with Foundation Porous Coated Acetabular Shell.	Device: Alumina/Alumina; CeramTec Acetabular Alumina Insert and CeramTec Alumina head used with Foundation Porous Coated Acetabular Shell
Active Comparator: Control Device Foundation Porous Coated Acetabular Shell with Polyethylene Insert with the CeramTec Alumina head.	Device: Standard; Foundation Porous Coated Acetabular Shell with Polyethylene Insert with the CeramTec Alumina head

Outcome Measures

Primary Outcome Measures

1. Alumina/Alumina articulation will perform as well as the alumina/polyethylene. [5 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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

Sponsors and Collaborators

• Encore Medical, L.P.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Sponsor company home page

Publications

None provided.

• Responsible Party: Encore Medical, L.P.
• ClinicalTrials.gov Identifier: NCT00764530
• Other Study ID Numbers: Study 100
• First Posted: Oct 2, 2008
• Last Update Posted: Jul 28, 2017
• Last Verified: Jul 1, 2017

• Additional relevant MeSH terms: Arthritis; Necrosis

Study Results

No Results Posted as of Jul 28, 2017