OsteoarthritisNCT00764894
Foundation Knee Study - Retrospective
An observational study of Osteoarthritis and Post-traumatic Arthritis, run by Encore Medical, L.P. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the use and efficacy of the Encore Foundation Knee System in a group of 200 patients for whom data has already been collected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Post-traumatic Arthritis, Inflammatory Tissue Disorders
- What is being tested?
- Foundation Knee
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Feb 2011
- 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 the indications for use of the Foundation Knee device AND who meet the inclusion/exclusion criteria
Who may be able to join
- Have knee joint disease related to one or more of the following
- osteoarthritis
- post-traumatic arthritis
- inflammatory tissue disorders
- arthritis secondary to other diseases
- Avascular necrosis of the femoral condyles;
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- Skeletal maturity
- Less than 70 on the Knee Society Score (rating score)
- Sufficient bone stock, as judged by radiographs, to support primary knee implant
- Sufficient collateral ligaments to support the device, as judged by physician during stability testing (varus/valgus and flexion/extension) and less than 45 degree varus/valgus deformity and/or 90 degree flexion contracture
- 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
- No infection present
- No known materials sensitivity
Who cannot join
- Skeletal immaturity
- Greater than or equal to 70 on preoperative Knee Society Score (Rating Score)
- Post-patellectomy
- Insufficient bone quality which may affect implant stability
- Insufficient collateral ligaments, as judged by the physician. Greater than 45 degree varus/valgus deformity and/or 90 degree flexion contracture.
- Neurological conditions that might hinder patient's ability to follow study procedures (i.e., any that restrict physical activities such as Parkinson's Disease, Multiple Sclerosis, previous stroke which affects lower extremity)
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- Mental conditions that may interfere with ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the patient cannot understand the informed consent process, global dementia, prior strokes that interfere with the patient's cognitive abilities, senile dementia, and Alzheimer's Disease)
- Prisoners
- Conditions that place excessive demand on the implant (i.e. Charcot's joints, muscle deficiencies, refusal to modify postoperative physical activities, skeletal immaturity)
- Patient is pregnant
- Infection present
- Materials sensitivity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-Market Study of the Foundation Knee System
The purpose of this study is to evaluate the use and efficacy of the Encore Foundation Knee System in a group of 200 patients for whom data has already been collected.
- Conditions
- Osteoarthritis, Post-traumatic Arthritis, Inflammatory Tissue Disorders, Arthritis Secondary to Other Diseases, Avascular Necrosis of the Femoral Condyles
- Being tested
- Foundation Knee
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foundation KneeDevice
Subjects with degenerative joint disease (DJD), osteoarthritis or rheumatoid arthritis who received a primary Foundation Knee replacement and is willing to participate in the study.
| Study group | Role | What they receive |
|---|---|---|
| Foundation Knee | Retrospective data collection on 510(k) approved device Receives: Device: Foundation Knee |
What is being measured
The primary outcome is the main question the study is designed to answer.
The use and efficacy of the Encore Foundation 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 startOct 2007
- Primary completionFeb 2011
- Study completionFeb 2011
Why it stopped: Enrollment and data collection insufficient to continue study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Encore Medical, L.P.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Omar Hussamy, M.D., Principal investigator, Hussamy Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764894
- Sponsor's protocol ID
- PS - 701
- Status last verified
- Feb 2011
- First submitted
- 30 Sep 2008
- Last updated
- 9 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Study of the Foundation Knee System
- ClinicalTrials.gov ID
- NCT00764894
- Acronym / sponsor ID
- PS - 701
- Conditions
- Osteoarthritis, Post-traumatic Arthritis, Inflammatory Tissue Disorders, Arthritis Secondary to Other Diseases, Avascular Necrosis of the Femoral Condyles
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Enrollment and data collection insufficient to continue study.
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Encore Medical, L.P.Industry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (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 evaluate the use and efficacy of the Encore Foundation Knee System in a group of 200 patients for whom data has already been collected.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Foundation Knee | – | Device: Foundation KneeRetrospective data collection on 510(k) approved device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who meet the indications for use of the Foundation Knee device AND who meet the inclusion/exclusion criteria
Key inclusion criteria (15 listed)
- Have knee joint disease related to one or more of the following
- Skeletal maturity
- Less than 70 on the Knee Society Score (rating score)
- Sufficient bone stock, as judged by radiographs, to support primary knee implant
- Sufficient collateral ligaments to support the device, as judged by physician during stability testing (varus/valgus and flexion/extension) and less than 45 degree varus/valgus deformity and/or 90 degree flexion contracture
Key exclusion criteria (12 listed)
- Skeletal immaturity
- Greater than or equal to 70 on preoperative Knee Society Score (Rating Score)
- Post-patellectomy
- Insufficient bone quality which may affect implant stability
- Insufficient collateral ligaments, as judged by the physician. Greater than 45 degree varus/valgus deformity and/or 90 degree flexion contracture.
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 |
|---|---|---|
| Foundation KneeSubjects with degenerative joint disease (DJD), osteoarthritis or rheumatoid arthritis who received a primary Foundation Knee replacement and is willing to participate in the study. | Device | Foundation Knee |
Primary outcome
The use and efficacy of the Encore Foundation Knee System
Time frame: 2 year
Results and safety
The study was stopped early (reason given: Enrollment and data collection insufficient to continue study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2011.
- 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.
Omar Hussamy, M.D. principal investigator
Hussamy Orthopedics
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 Osteoarthritis and Post-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 15 inclusion and 12 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 9 Feb 2011. 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: Enrollment and data collection insufficient to continue study.). 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 use and efficacy of the Encore Foundation 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 9 Feb 2011.