Cementless Alumina-Alumina Total Hip and Hybrid
This study is ongoing, but not recruiting participants.
Sponsor:
Encore Medical, L.P.
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis Osteoarthritis Post-traumatic Arthritis Avascular Necrosis |
Device: Alumina/Alumina Device: Standard |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Keramos Ceramic/Ceramic Total Hip System |
Resource links provided by NLM:
Further study details as provided by Encore Medical, L.P.:
Primary Outcome Measures:
- Alumina/Alumina articulation will perform as well as the alumina/polyethylene. [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]
| Enrollment: | 342 |
| Study Start Date: | November 2003 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00764530
Locations
| United States, California | |
| Mark Newman, Inc. | |
| Newport Beach, California, United States, 92663 | |
| United States, South Carolina | |
| Charleston Orthopaedic Assoc. | |
| Charleston, South Carolina, United States, 29414 | |
| United States, Virginia | |
| Advanced Orthopaedic Centers | |
| Richmond, Virginia, United States, 23294 | |
Sponsors and Collaborators
Encore Medical, L.P.
More Information
Additional Information:
No publications provided
| Responsible Party: | Encore Medical, L.P. |
| ClinicalTrials.gov Identifier: | NCT00764530 History of Changes |
| Other Study ID Numbers: | Study 100 |
| Study First Received: | September 30, 2008 |
| Last Updated: | November 2, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Necrosis Osteonecrosis Osteoarthritis Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes Bone Diseases |
ClinicalTrials.gov processed this record on May 16, 2013