Rheumatoid ArthritisNCT00764530
Cementless Alumina-Alumina Total Hip and Hybrid
A study testing Alumina/Alumina and Standard in people with Rheumatoid Arthritis and Osteoarthritis, run by Encore Medical, L.P. at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis
- What is being tested?
- Alumina/Alumina and Standard
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 342 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2003to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 25Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Charleston Orthopaedic Assoc.
Charleston, South Carolina, 29414
Mark Newman, Inc.
Newport Beach, California, 92663
Advanced Orthopaedic Centers
Richmond, Virginia, 23294
About this study
Official title: Keramos Ceramic/Ceramic Total Hip System
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.
- Being tested
- Alumina/Alumina, Standard
- Medical subject headings
- Arthritis, Rheumatoid, Osteoarthritis, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alumina/AluminaDevice
CeramTec Acetabular Alumina Insert and CeramTec Alumina head used with Foundation Porous Coated Acetabular Shell
StandardDevice
Foundation Porous Coated Acetabular Shell with Polyethylene Insert with the CeramTec Alumina head
| Study group | Role | What they receive |
|---|---|---|
| Investigational | Experimental | CeramTec Acetabular Alumina Insert and CeramTec Alumina head used with Foundation Porous Coated Acetabular Shell. Receives: Device: Alumina/Alumina |
| Control Device | Active comparator | Foundation Porous Coated Acetabular Shell with Polyethylene Insert with the CeramTec Alumina head. Receives: Device: Standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alumina/Alumina articulation will perform as well as the alumina/polyethylene.
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2008 (estimated)
- Study startNov 2003
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- Encore Medical, L.P.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764530
- Sponsor's protocol ID
- Study 100
- Status last verified
- Jul 2017
- First submitted
- 30 Sep 2008
- Last updated
- 28 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Keramos Ceramic/Ceramic Total Hip System
- ClinicalTrials.gov ID
- NCT00764530
- Acronym / sponsor ID
- Study 100
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- Encore Medical, L.P.Industry (pharma, biotech, devices)
- Study start
- Nov 2003
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 2 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational | Experimental | Device: Alumina/AluminaCeramTec Acetabular Alumina Insert and CeramTec Alumina head used with Foundation Porous Coated Acetabular Shell. |
| Control Device | Active comparator | Device: StandardFoundation Porous Coated Acetabular Shell with Polyethylene Insert with the CeramTec Alumina head. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (25 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alumina/AluminaCeramTec Acetabular Alumina Insert and CeramTec Alumina head used with Foundation Porous Coated Acetabular Shell | Device | Investigational |
| StandardFoundation Porous Coated Acetabular Shell with Polyethylene Insert with the CeramTec Alumina head | Device | Control Device |
Primary outcome
Alumina/Alumina articulation will perform as well as the alumina/polyethylene.
Time frame: 5 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2017.
- Sponsor company home pageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alumina/Alumina and Standard in people with Rheumatoid Arthritis and Osteoarthritis, run by Encore Medical, L.P. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alumina/Alumina articulation will perform as well as the alumina/polyethylene. (time frame: 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2017; AzTrials last refreshed its copy on 7 Nov 2026.