Degenerative Joint DiseaseNCT00819481
Post-Market Study of the 3DKnee™ System
An observational study of Degenerative Joint Disease and Osteoarthritis, run by Encore Medical, L.P. at 8 sites in United States.
Trial summary
The purpose of this study is to evaluate the use and efficacy of the 3DKnee™ System for total knee replacement surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Joint Disease, Osteoarthritis, Rheumatoid Arthritis
- What is being tested?
- 3DKnee™ System
- Type of treatment
- Medical device
- How many people
- 229 participants
- Where
- 8 sitesUnited States
- Study dates
- Feb 2009to Oct 2018
- 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: Patients who are over 18 years of age and are candidates for a primary total knee replacement.
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
- Have knee joint disease related to one or more of the following
- degenerative joint disease, including osteoarthritis or traumatic arthritis
- Avascular necrosis of the femoral condyles
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
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- Moderate valgus, varus, or flexion deformities
- Rheumatoid arthritis
- 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)
- Infection, or history of infection, acute or chronic, local or systemic
- Alcoholism or other addictions
- Muscular, neurological or vascular deficiencies which compromise the affected extremity
- Obesity
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- Insufficient bone quality
- Loss of ligamentous structures
- High levels of physical activity
- 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
8 sites in 1 country.
8 sites in 1 country
United States8 sites
OrthoMaryland
Baltimore, Maryland, 21209
Leslie Orthopedics and Sports Medicine
Camdenton, Missouri, 65020
St. Peter's Bone & Joint Surgery
City of Saint Peters, Missouri, 63376
Center for Excellence
Fresno, California, 93710
Texas Center for Joint Replacement
Plano, Texas, 75093
Longo Orthopedics
Scottsdale, Arizona, 85251
Metro Orthopedics and Sports Therapy
Silver Spring, Maryland, 20910
Rimrock Orthopedics
St. George, Utah, 84790
About this study
Official title: Post-Market Study of the 3DKnee™ System Protocol No. PS -- 700
The purpose of this study is to evaluate the use and efficacy of the 3DKnee™ System for total knee replacement surgery.
Read the detailed description
Total knee replacement surgery is widely accepted as effective treatment for degenerative joint disease (DJD), osteoarthritis and rheumatoid arthritis. Relief of patient pain and return of mobility are the primary goals that can be accomplished by this surgery. The purpose of this study is to evaluate the use and efficacy of the 3DKnee™ System for total knee replacement surgery. The study will take place at multiple sites across the United States and be managed by the Encore Medical Clinical Affairs Department. The study will include only patients who meet the indications for use criteria for the 3DKnee™ System and who are candidates for primary knee arthroplasty.
- Being tested
- 3DKnee™ System
- Keywords
- Total knee replacement
- Medical subject headings
- Joint Diseases, Osteoarthritis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3DKnee™ SystemDevice
Total knee replacement joint for subjects with knee osteoarthritis and willing to participate in the study.
| Study group | Role | What they receive |
|---|---|---|
| 3DKnee | Post Market Study Receives: Device: 3DKnee™ System |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of total knee system
Measured: 2 year
Secondary outcomes (5)
change in Knee Society Score
Measured: 5 year
change in pain from pre-op to post-op
Measured: 5 year
patient satisfaction
Measured: 5 year
change in WOMAC Osteoarthritis Index from pre-surgery
Measured: 5 year
change in Oxford Knee Score from pre-surgery
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 posted9 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionJan 2014
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Joint DiseaseStudies 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
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Encore Medical, L.P.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John W. McAllister, M.D., Principal investigator, St. Peter's Bone and Joint SurgeryBarry J Waldman, M.D., Principal investigator, OrthoMaryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00819481
- Sponsor's protocol ID
- PS - 700
- Status last verified
- Feb 2017
- First submitted
- 8 Jan 2009
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Study of the 3DKnee™ System Protocol No. PS -- 700
- ClinicalTrials.gov ID
- NCT00819481
- Acronym / sponsor ID
- PS - 700
- Keywords
- Total knee replacement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Encore Medical, L.P.Industry (pharma, biotech, devices)
- Study start
- Feb 2009 (actual)
- Primary completion
- Jan 2014 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 9 Jan 2009 (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 3DKnee™ System for total knee replacement surgery.
Detailed description
Total knee replacement surgery is widely accepted as effective treatment for degenerative joint disease (DJD), osteoarthritis and rheumatoid arthritis. Relief of patient pain and return of mobility are the primary goals that can be accomplished by this surgery. The purpose of this study is to evaluate the use and efficacy of the 3DKnee™ System for total knee replacement surgery. The study will take place at multiple sites across the United States and be managed by the Encore Medical Clinical Affairs Department. The study will include only patients who meet the indications for use criteria for the 3DKnee™ System and who are candidates for primary knee arthroplasty.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3DKnee | – | Device: 3DKnee™ SystemPost Market Study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are over 18 years of age and are candidates for a primary total knee replacement.
Key inclusion criteria (11 listed)
- This must be a primary knee replacement on this knee.
- Patient is over 18 years of age or older
- Have knee joint disease related to one or more 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 (13 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)
- Infection, or history of infection, acute or chronic, local or systemic
- 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 |
|---|---|---|
| 3DKnee™ SystemTotal knee replacement joint for subjects with knee osteoarthritis and willing to participate in the study. | Device | 3DKnee |
Primary outcome
efficacy of total knee system
Time frame: 2 year
5 secondary outcomes
change in Knee Society Score
Time frame: 5 year
change in pain from pre-op to post-op
Time frame: 5 year
patient satisfaction
Time frame: 5 year
change in WOMAC Osteoarthritis Index from pre-surgery
Time frame: 5 year
change in Oxford Knee Score from pre-surgery
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 16 Mar 2021.
- 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.
John W. McAllister, M.D. principal investigator
St. Peter's Bone and Joint Surgery
Barry J Waldman, M.D. principal investigator
OrthoMaryland
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Joint Disease and Osteoarthritis, run by Encore Medical, L.P. at 8 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 11 inclusion and 13 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 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
efficacy of total 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 16 Mar 2021.