Rheumatoid ArthritisNCT00764803
3DKnee™ System vs. the MJS Knee System
An observational study of Rheumatoid Arthritis and Traumatic Arthritis, run by Encore Medical, L.P. at 1 site in United States.
Trial summary
The purpose of this study is to compare the survivorship and efficacy of the Encore 3DKnee™ system with that of the Encore MJS™ Knee System in a group of 600 patients for whom data collection is already under way. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Traumatic Arthritis, Joint Disease Secondary to Osteoarthritis
- What is being tested?
- Encore 3DKnee™ system and Encore MJS™ Knee System
- Type of treatment
- Medical device
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Dec 2009
- Phase
- Observational
- 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
Study population: Individuals who meet either the indications for use of the 3DKnee or the MJS knee system. Subjects must also meet the inclusion/exclusion criteria.
Who may be able to join
- This must be a primary knee replacement on this knee.
- Patient is over 18 years of age or older
- Patients must have one of the following
- rheumatoid or traumatic arthritis OR
- joint disease secondary to osteoarthritis
- Patient is likely to be available for evaluation for the duration of the study
- Able and willing to sign the informed consent and follow study procedures
- Patient is not pregnant
Who cannot join
- Is younger than 18 years of age
- If there has been a total knee replacement on this knee in the past (no revisions allowed in study)
- Overt infection
- Alcoholism or other addictions
- Muscular, neurological or vascular deficiencies which compromise the affected extremity
- Obesity
Show all 11Show fewer
- Marked bone loss
- Materials sensitivity
- Prisoner
- Mental conditions that may interfere with the patient's ability to give an informed consent or willingness to fulfill the study requirements
- Patient is pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-Market Study: The Efficacy of the 3DKnee™ System vs. the MJS Knee System
The purpose of this study is to compare the survivorship and efficacy of the Encore 3DKnee™ system with that of the Encore MJS™ Knee System in a group of 600 patients for whom data collection is already under way.
Read the detailed description
The purpose of this study is to compare the survivorship and efficacy of the Encore 3DKnee™ system with that of the Encore MJS™ Knee System in a group of 600 patients for whom data collection is already under way. Approximately 300 patients have already received the MJS™ knee system and data, as described below, has been collected for these patients over a period of two years. A second group of 300 patients will receive the Encore 3DKnee™ system over the next two years, and equivalent data will be collected for these individuals. A portion of the data has been collected over the past year, and now we would like to obtain permission from the patients to analyze these data as well as collect an additional year of data.
- Being tested
- Encore 3DKnee™ system, Encore MJS™ Knee System
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Encore 3DKnee™ systemDevice
Subjects with rheumatoid arthritis, traumatic arthritis or osteoarthritis who were implanted with the Encore 3DKnee™ system and willing to participate in the study.
Encore MJS™ Knee SystemDevice
Subjects with rheumatoid arthritis, traumatic arthritis or osteoarthritis who were implanted with the Encore MJS™ Knee system and willing to participate in the study.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Subjects who meet the indications for use and are implanted with the Encore MJS™ Knee System. Receives: Device: Encore MJS™ Knee System | |
| 1 | Subjects who meet the indications for and are implanted with the Encore 3DKnee™ system. Receives: Device: Encore 3DKnee™ system |
What is being measured
The primary outcome is the main question the study is designed to answer.
The survivorship and efficacy of the Encore 3DKnee™ system with that of the Encore MJS™ Knee System
Measured: 2 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 startJan 2008
- Primary completionNov 2009
- Study completionDec 2009
Why it stopped: Corporate decision to discontinue distribution of MJS Knee.
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Encore Medical, L.P.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- D. Kevin Lester, M.D., Principal investigator, Center for Excellence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764803
- Sponsor's protocol ID
- PS - 702
- Status last verified
- Mar 2010
- First submitted
- 30 Sep 2008
- Last updated
- 11 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Study: The Efficacy of the 3DKnee™ System vs. the MJS Knee System
- ClinicalTrials.gov ID
- NCT00764803
- Acronym / sponsor ID
- PS - 702
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Corporate decision to discontinue distribution of MJS Knee.
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Encore Medical, L.P.Industry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2009 (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.
The purpose of this study is to compare the survivorship and efficacy of the Encore 3DKnee™ system with that of the Encore MJS™ Knee System in a group of 600 patients for whom data collection is already under way.
Detailed description
The purpose of this study is to compare the survivorship and efficacy of the Encore 3DKnee™ system with that of the Encore MJS™ Knee System in a group of 600 patients for whom data collection is already under way. Approximately 300 patients have already received the MJS™ knee system and data, as described below, has been collected for these patients over a period of two years. A second group of 300 patients will receive the Encore 3DKnee™ system over the next two years, and equivalent data will be collected for these individuals. A portion of the data has been collected over the past year, and now we would like to obtain permission from the patients to analyze these data as well as collect an additional year of data.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | – | Device: Encore MJS™ Knee SystemSubjects who meet the indications for use and are implanted with the Encore MJS™ Knee System. |
| 1 | – | Device: Encore 3DKnee™ systemSubjects who meet the indications for and are implanted with the Encore 3DKnee™ system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who meet either the indications for use of the 3DKnee or the MJS knee system. Subjects must also meet the inclusion/exclusion criteria.
Key inclusion criteria (8 listed)
- This must be a primary knee replacement on this knee.
- Patient is over 18 years of age or older
- Patients must have one of the following
- Patient is likely to be available for evaluation for the duration of the study
- Able and willing to sign the informed consent and follow study procedures
Key exclusion criteria (11 listed)
- Is younger than 18 years of age
- If there has been a total knee replacement on this knee in the past (no revisions allowed in study)
- Overt infection
- Alcoholism or other addictions
- Muscular, neurological or vascular deficiencies which compromise the affected extremity
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 |
|---|---|---|
| Encore 3DKnee™ systemSubjects with rheumatoid arthritis, traumatic arthritis or osteoarthritis who were implanted with the Encore 3DKnee™ system and willing to participate in the study. | Device | 1 |
| Encore MJS™ Knee SystemSubjects with rheumatoid arthritis, traumatic arthritis or osteoarthritis who were implanted with the Encore MJS™ Knee system and willing to participate in the study. | Device | 2 |
Primary outcome
The survivorship and efficacy of the Encore 3DKnee™ system with that of the Encore MJS™ Knee System
Time frame: 2 year
Results and safety
The study was stopped early (reason given: Corporate decision to discontinue distribution of MJS Knee.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2010.
- 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.
D. Kevin Lester, M.D. principal investigator
Center for Excellence
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Traumatic Arthritis, run by Encore Medical, L.P. at 1 site 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 8 inclusion and 11 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: stopped early, as of the sponsor's last update on 11 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Corporate decision to discontinue distribution of MJS Knee.). Results are not available in the source record.
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?
The survivorship and efficacy of the Encore 3DKnee™ system with that of the Encore MJS™ Knee System (time frame: 2 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 11 Mar 2010.