Total Knee ReplacementNCT01274546
Long Term Foundation Knee Study
An observational study of Total Knee Replacement, run by Encore Medical, L.P. at 2 sites in United States.
Trial summary
The purpose of this study is to obtain long-term (10+ yrs) clinical and patient outcomes data on patients who received the cruciate-retaining Foundation Knee system during or prior to the year 2000. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- cruciate-retaining Foundation Knee system
- Type of treatment
- Medical device
- How many people
- 43 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2010to Jul 2012
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study will include only subjects who received the cruciate-retaining Foundation Knee System during or before the year 2000 and who voluntarily consent to take part in this study.
Who may be able to join
- Subject must have received a cruciate-retaining Foundation Knee system during or prior to the year 2000.
- Surgery must have been a primary knee replacement.
- Subject must have received only one primary knee replacement per hospitalization
- Subject must have had a primary diagnosis of osteoarthritis of the operative knee.
- Subject is able and willing to sign the informed consent document
Who cannot join
- Subject must not have had any previous knee implants (unicondylar or total joint replacements)
- Subject has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
- Subject is a prisoner
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Charleston Orthopaedic Assoc.
Charleston, South Carolina, 29414
Study site
Scottsdale, Arizona, 85251
About this study
Official title: A Long-term, Multicenter Follow Up Study of the Cruciate-retaining Foundation Knee System
The purpose of this study is to obtain long-term (10+ yrs) clinical and patient outcomes data on patients who received the cruciate-retaining Foundation Knee system during or prior to the year 2000.
- Conditions
- Total Knee Replacement
- Being tested
- cruciate-retaining Foundation Knee system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cruciate-retaining Foundation Knee systemDevice
subjects who received the cruciate-retaining Foundation Knee system greater than or equal to 10 years ago and still maintain the original device in their knee.
| Study group | Role | What they receive |
|---|---|---|
| "In Office" | These subjects will come into the office to perform the consenting process, and complete all evaluations required at the only visit in the study. Receives: Device: cruciate-retaining Foundation Knee system | |
| "Telephone Arm" | These subjects will be consented over the phone and give a verbal consent to participate. They will complete all aspects of the study over the phone except for the knee society score evaluation and the x-ray. Receives: Device: cruciate-retaining Foundation Knee system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivorship of the Device
The subject meets the inclusion/exclusion of the study and has a Foundation Knee that has survived without revision to date.
Measured: Single visit
Secondary outcomes (6)
Knee Society Score Evaluation
The knee society score includes both a subjective and a function score. The subjective score includes pain, stability and range of motion. The function score includes values for walking distance and climbing stairs.
Measured: Single visit
Short Form - 36
SF-36 quality of life assessment questionnaire.
Measured: Single Visit
Oxford Knee Score Assessment
Questionnaire
Measured: Single visit
WOMAC Osteoarthritis Index
Questionnaire
Measured: Single visit
Range of Motion
Physician measurements of the subjects range of motion on the operated knee.
Measured: Single visit
Radiographic failure
Radiographic failure is defined as a shift in the position of the component >3mm or 3 degrees or a >2mm radiolucency completely around the prosthesis.
Measured: Single visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2011 (estimated)
- Study startAug 2010
- Primary completionMay 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ReplacementStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Encore Medical, L.P.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard J Friedman, M.D., Principal investigator, Charleston Orthopedic AssociationJoseph A Longo III, M.D., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01274546
- Sponsor's protocol ID
- PS-705
- Status last verified
- Aug 2012
- First submitted
- 10 Jan 2011
- Last updated
- 7 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term, Multicenter Follow Up Study of the Cruciate-retaining Foundation Knee System
- ClinicalTrials.gov ID
- NCT01274546
- Acronym / sponsor ID
- PS-705
- Conditions
- Total Knee Replacement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Encore Medical, L.P.Industry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 11 Jan 2011 (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 obtain long-term (10+ yrs) clinical and patient outcomes data on patients who received the cruciate-retaining Foundation Knee system during or prior to the year 2000.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "In Office" | – | Device: cruciate-retaining Foundation Knee systemThese subjects will come into the office to perform the consenting process, and complete all evaluations required at the only visit in the study. |
| "Telephone Arm" | – | Device: cruciate-retaining Foundation Knee systemThese subjects will be consented over the phone and give a verbal consent to participate. They will complete all aspects of the study over the phone except for the knee society score evaluation and the x-ray. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will include only subjects who received the cruciate-retaining Foundation Knee System during or before the year 2000 and who voluntarily consent to take part in this study.
Key inclusion criteria (5 listed)
- Subject must have received a cruciate-retaining Foundation Knee system during or prior to the year 2000.
- Surgery must have been a primary knee replacement.
- Subject must have received only one primary knee replacement per hospitalization
- Subject must have had a primary diagnosis of osteoarthritis of the operative knee.
- Subject is able and willing to sign the informed consent document
Key exclusion criteria (3 listed)
- Subject must not have had any previous knee implants (unicondylar or total joint replacements)
- Subject has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
- Subject is a prisoner
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 |
|---|---|---|
| cruciate-retaining Foundation Knee systemsubjects who received the cruciate-retaining Foundation Knee system greater than or equal to 10 years ago and still maintain the original device in their knee. | Device | "In Office", "Telephone Arm" |
Primary outcome
Survivorship of the Device
Time frame: Single visit
The subject meets the inclusion/exclusion of the study and has a Foundation Knee that has survived without revision to date.
6 secondary outcomes
Knee Society Score Evaluation
Time frame: Single visit
Short Form - 36
Time frame: Single Visit
Oxford Knee Score Assessment
Time frame: Single visit
WOMAC Osteoarthritis Index
Time frame: Single visit
Range of Motion
Time frame: Single visit
Radiographic failure
Time frame: Single visit
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 7 Aug 2012.
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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.
Richard J Friedman, M.D. principal investigator
Charleston Orthopedic Association
Joseph A Longo III, M.D. principal investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Replacement, run by Encore Medical, L.P. at 2 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 5 inclusion and 3 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 7 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Survivorship of the Device (time frame: Single visit). 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 7 Aug 2012; AzTrials last refreshed its copy on 31 Oct 2026.