OsteoarthritisEPIKNCT01464632
Post-Market Study of the EPIK Knee System
An observational study of Osteoarthritis and Post Traumatic Degenerative Disease, run by Encore Medical, L.P. at 1 site in United States.
Trial summary
The purpose of this study is to determine the short-term (2 yr) and midterm (5 yr) cumulative revision rates of the EPIK™ Uni-compartmental Knee System. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Osteoarthritis, Post Traumatic Degenerative Disease
- What is being tested?
- EPIK™ uni-compartmental knee
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to May 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients who are between 18 years of age and 60 years of age at time of consent and have one side of the knee joint affected by compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures or deformity.
Who may be able to join
- Meet the indications for use of the EPIK Uni-compartmental knee system
- Must be a primary surgery
- Have a primary diagnosis of OA in the medial knee compartment
- Have active and passive flexion > 90º
- Have a fixed flexion contracture < 10º
- Have an intact ACL and PCL
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- Be a primary, unilateral surgery
- Have BMI ≤ 35.00
- Must not have infection (or history of infection within last 3 months), chronic or acute, local or systemic
- Must not be pregnant
- Be willing and able to sign the informed consent
- Be willing to follow study procedures, including all follow up visits
- Be over 18 years of age (≥ 18) and 60 years or younger (≤ 60) at time of consent
Who cannot join
- Prior total or uni-knee arthroplasty (must be a primary surgery)
- Patello-femoral joint symptoms
- Bilateral surgical procedures
- BMI > 35.00
- Muscular, neurological or vascular deficiencies which compromise the affected extremity
- Insufficient bone quality which may affect the stability of the implant
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- Infection (or history of infection within last 3 months), chronic or acute, local or systemic
- Is younger than 18 years of age (<18) or over 60 (>60) years of age
- Mental conditions that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements
- High levels of physical activity (ex. Competitive sports, heavy physical labor)
- Documented (active) alcohol or drug addictions
- Loss of ligamentous structures
- Prisoner
- Metals sensitivity
- Subject is pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Open Label Study of the Short-and Midterm Safety and Efficacy of the EPIK Uni-Compartmental Knee System in Community Practice
The purpose of this study is to determine the short-term (2 yr) and midterm (5 yr) cumulative revision rates of the EPIK™ Uni-compartmental Knee System.
Read the detailed description
Medial uni-compartmental knee replacement (UKA) has been used for over 40 years to treat osteoarthritis (OA) of the knee. It is becoming more widely accepted as a treatment for early stage OA of the knee in order to preserve bony and ligamentous structures. The majority of the subjects who have received this knee are older (over 65 yrs) however, it is being used increasingly more frequently in younger individuals who have uni-compartmental knee disease so that bone may be spared in case the need arises in the future for a total knee arthroplasty. The study will take place at two sites within the United States and be managed by the Clinical Affairs Department at DJO Surgical in Austin, TX. The study will include only subjects who meet the indications for use criteria for the EPIK™ Uni-compartmental Knee System and who are candidates for UKA. Investigators will enroll up to 60 subjects at each of 2 sites within the United States, for a total of 100 subjects maximum.
- Being tested
- EPIK™ uni-compartmental knee
- Keywords
- medial knee replacement
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPIK™ uni-compartmental kneeDevice
Also called EPIK
This device is intended for partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity, or revision of previous arthroplasty.
| Study group | Role | What they receive |
|---|---|---|
| Primary | Post Market Study Receives: Device: EPIK™ uni-compartmental knee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revision Rate Post Surgery
To determine the number of revisions that occur to total knee replacements after receiving the uni-compartmental knee replaceement.
Measured: 5 years
Secondary outcomes (1)
Revision rate post surgery
To determine the number of revisions that occur to total knee replacements after receiving the uni-compartmental knee replaceement.
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 posted3 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionMay 2012
- Study completionMay 2012
Why it stopped: Unable to enroll any study participants.
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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Encore Medical, L.P.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christina M Sheely, D.O., Principal investigator, Hill Country Sports Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01464632
- Sponsor's protocol ID
- PS-707
- Acronym
- EPIK
- Status last verified
- May 2012
- First submitted
- 2 Nov 2011
- Last updated
- 16 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open Label Study of the Short-and Midterm Safety and Efficacy of the EPIK Uni-Compartmental Knee System in Community Practice
- ClinicalTrials.gov ID
- NCT01464632
- Acronym / sponsor ID
- EPIK / PS-707
- Keywords
- medial knee replacement
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Unable to enroll any study participants.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Encore Medical, L.P.Industry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 3 Nov 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 determine the short-term (2 yr) and midterm (5 yr) cumulative revision rates of the EPIK™ Uni-compartmental Knee System.
Detailed description
Medial uni-compartmental knee replacement (UKA) has been used for over 40 years to treat osteoarthritis (OA) of the knee. It is becoming more widely accepted as a treatment for early stage OA of the knee in order to preserve bony and ligamentous structures. The majority of the subjects who have received this knee are older (over 65 yrs) however, it is being used increasingly more frequently in younger individuals who have uni-compartmental knee disease so that bone may be spared in case the need arises in the future for a total knee arthroplasty. The study will take place at two sites within the United States and be managed by the Clinical Affairs Department at DJO Surgical in Austin, TX. The study will include only subjects who meet the indications for use criteria for the EPIK™ Uni-compartmental Knee System and who are candidates for UKA. Investigators will enroll up to 60 subjects at each of 2 sites within the United States, for a total of 100 subjects maximum.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary | – | Device: EPIK™ uni-compartmental kneePost Market Study |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients who are between 18 years of age and 60 years of age at time of consent and have one side of the knee joint affected by compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures or deformity.
Key inclusion criteria (13 listed)
- Meet the indications for use of the EPIK Uni-compartmental knee system
- Must be a primary surgery
- Have a primary diagnosis of OA in the medial knee compartment
- Have active and passive flexion > 90º
- Have a fixed flexion contracture < 10º
Key exclusion criteria (15 listed)
- Prior total or uni-knee arthroplasty (must be a primary surgery)
- Patello-femoral joint symptoms
- Bilateral surgical procedures
- BMI > 35.00
- 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 |
|---|---|---|
| EPIK™ uni-compartmental kneeAlso: EPIKThis device is intended for partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity, or revision of previous arthroplasty. | Device | Primary |
Primary outcome
Revision Rate Post Surgery
Time frame: 5 years
To determine the number of revisions that occur to total knee replacements after receiving the uni-compartmental knee replaceement.
1 secondary outcome
Revision rate post surgery
Time frame: 2 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 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.
Christina M Sheely, D.O. principal investigator
Hill Country Sports Medicine
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 Degenerative Disease, 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 13 inclusion and 15 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: withdrawn, as of the sponsor's last update on 16 May 2012. 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 withdrawn before enrolling participants, so there are no results.
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?
Revision Rate Post Surgery (time frame: 5 years). 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 16 May 2012.