Degenerative Joint Diseasee-plusNCT01551472
Post Market Study of the 3DKnee™ With E-plus Insert
An observational study of Degenerative Joint Disease and Osteoarthritis, run by Encore Medical, L.P. at 6 sites in United States.
Trial summary
The purpose of this study is to evaluate the use and efficacy of the 3DKnee™ System using Vitamin E UHMWPE tibial inserts for total knee replacement surgery. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Degenerative Joint Disease, Osteoarthritis, Traumatic Arthritis
- What is being tested?
- 3DKnee™ System with Vitamin E UHMWPE Tibial Inserts
- Type of treatment
- Medical device
- How many people
- 175 participants
- Where
- 6 sitesUnited States
- Study dates
- Apr 2012to Jan 2022
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects must be diagnosed with either osteoarthritis or traumatic arthritis and be candidates for a primary total knee arthroplasty. They must also meet the indications for use for the 3DKnee system with the vitamin E tibial insert.
Who may be able to join
- Subject must be a candidate for a total primary knee replacement.
- Subject must have knee joint disease related to degenerative joint disease, including osteoarthritis or traumatic arthritis
- Subject has a BMI ≤ 40.00 kg/m2
- Subject is likely to be available for evaluation for the duration of the study
- Subject is able and willing to sign the informed consent and follow study procedures
- Subject is not pregnant
- Subject must be between age 40 and age 75 at the time of consent
Who cannot join
- Subject has had a prior total or uni-knee replacement on this knee in the past (no revisions allowed in study)
- Subject has avascular necrosis of the femoral condyles, post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities or rheumatoid arthritis
- Subject has an active cancer or is a survivor for <5 years except for squamous cell or basal cell skin cancer
- Subject has a chronic disease(s) where, in the opinion of the investigator, the disease will interfere with the patient's ability to follow the protocol
- Subject is currently a documented substance abuser (alcohol or other addictions)
- Subject has an infection, or history of infection (within the last 3 months), acute or chronic, local or systemic
Show all 15Show fewer
- Subject has a history of muscular, neurological or vascular deficiencies which compromise the affected extremity
- Subject has a BMI > 40.00 kg/m2
- Subject has loss of ligamentous structures
- Subject has high levels of physical activity and is unwilling to modify levels of physical activity commensurate with recommendations
- 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
- Subject is pregnant
- Subject has known materials sensitivity (to metals)
- Subject is younger than 40 years (<40) or older than 75 years (>75) at the time of consent
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
New Mexico Orthopedics
Albuquerque, New Mexico, 87106
Texas Institute for Hip and Knee Surgery
Austin, Texas, 78751
Orthopaedic Surgery Specialists
Burbank, California, 91505
St. Peter's Bone & Joint Surgery
City of Saint Peters, Missouri, 63376
Institute for Orthopaedic Surgery and Sports Medicine
Fort Myers, Florida, 33919
Orthopedic Specialists of North County
Oceanside, California, 92056
About this study
Official title: Prospective Multicenter Open Label Study Examining the Mid- and Long-term Safety and Efficacy of the 3DKnee™ System With Vitamin E UHMWPE Tibial Inserts (3DKnee™ With E-plus Insert)
The purpose of this study is to evaluate the use and efficacy of the 3DKnee™ System using Vitamin E UHMWPE tibial inserts 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. Currently available prosthetic designs accomplish these goals and the surgery has been defined as one of the most successful operations available to improve the quality of life for patients with DJD. This study will evaluate subjects who are candidates for a total knee replacement and meet the indications for use criteria for the 3DKnee™ System with vitamin E UHMWPE tibial inserts (VE).
- Being tested
- 3DKnee™ System with Vitamin E UHMWPE Tibial Inserts
- Medical subject headings
- Joint Diseases, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3DKnee™ System with Vitamin E UHMWPE Tibial InsertsDevice
This device is part of a total knee replacement system utilized in treating patients who are candidates for primary cemented total knee arthroplasty or revision arthroplasty where bone loss is minimal and the collateral ligaments are intact. It is intended to aid the surgeon in relieving the patient of knee pain and restoring knee joint function.
| Study group | Role | What they receive |
|---|---|---|
| 3DKnee™ with e-plus Insert | Subjects who meet the indications for use criteria for the 3DKnee™ System with vitamin E UHMWPE tibial inserts (VE) and who are candidates for a primary knee arthroplasty. Receives: Device: 3DKnee™ System with Vitamin E UHMWPE Tibial Inserts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the Vitamin E UHMWPE as part of the total knee system, measured by Knee Society Score Evaluation and total number of radiologic failures of the device.
The (American) Knee Society Score has both an objective and a functional component. The objective score takes into account pain, flexion, stability, alignment, extension lag and flexion contracture. Overall success will be defined as a KSS score ≥ 80 at two years.
Radiolucencies have been defined as two types, with one type being more common than the other. In the case of physiologic radiolucency, which is the most common type of radiolucency seen, there is a narrow line present that is well-defined around the prosthesis. This line is surrounded by a radio-dense line and tends to consolidate (disappear) within the first year. The second type of radiolucency, the pathologic radiolucency, is rarer and is associated with loosening and infection. It is a progressive, poorly defined radiolucency that is more than 2 mm thick and without a radiolucent line.
Measured: 2 year
Secondary outcomes (5)
Change in Knee Society Score from pre-surgery to 10 years
The Knee Society Score includes a knee rating and function score. This evaluation covers the knee rating score with three main parameters of pain, stability and range of motion and that flexion contracture, extension lag and misalignment should be dealt with as deductions. Thus, 100 points will be obtained by a well-aligned knee with no pain, 125 degrees of motion, and negligible anteroposterior and mediolateral instability. 50 points are allotted for pain, 25 for stability, and 25 for range of motion. Grading for KS Score: Excellent (90-100), Good (80-90), Fair (70-79) and Poor (<70).
Measured: 10 year
Change in WOMAC Osteoarthritis Index from pre-surgery to 10 years
The Western Ontario McMaster Arthritis Index is a set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip. It can be self-administered. It assesses the pain, joint stiffness, physical, social \& emotional function of a person with osteoarthritis in determining the overall level of disability.
Measured: 10 year
Change in Oxford Knee Score from pre-surgery to 10 years
The Oxford Knee Score (OKS) is a patient-based outcomes measure consisting of 12 questions that is sensitive, simple and validated. It is based on a maximum score of 48.
Measured: 10 year
Change in response to Quality of Life questions from pre-surgery to 6 months and each year thereafter through 10 years
Measured: 10 years
6. Change in pain from pre-surgery to 6 months and each year thereafter through 10 years
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionJan 2022
- Study completionJan 2022
Why it stopped: Lack of sufficient enrollment
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
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Encore Medical, L.P.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- DJO Incorporated
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01551472
- Sponsor's protocol ID
- PS-706
- Acronym
- e-plus
- Status last verified
- Feb 2022
- First submitted
- 8 Mar 2012
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Open Label Study Examining the Mid- and Long-term Safety and Efficacy of the 3DKnee™ System With Vitamin E UHMWPE Tibial Inserts (3DKnee™ With E-plus Insert)
- ClinicalTrials.gov ID
- NCT01551472
- Acronym / sponsor ID
- e-plus / PS-706
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of sufficient enrollment
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Encore Medical, L.P.Industry (pharma, biotech, devices)
- Collaborators
- DJO Incorporated
- Study start
- Apr 2012 (actual)
- Primary completion
- Jan 2022 (actual)
- Study completion
- Jan 2022 (actual)
- First posted
- 12 Mar 2012 (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 using Vitamin E UHMWPE tibial inserts 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. Currently available prosthetic designs accomplish these goals and the surgery has been defined as one of the most successful operations available to improve the quality of life for patients with DJD. This study will evaluate subjects who are candidates for a total knee replacement and meet the indications for use criteria for the 3DKnee™ System with vitamin E UHMWPE tibial inserts (VE).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3DKnee™ with e-plus Insert | – | Device: 3DKnee™ System with Vitamin E UHMWPE Tibial InsertsSubjects who meet the indications for use criteria for the 3DKnee™ System with vitamin E UHMWPE tibial inserts (VE) and who are candidates for a primary knee arthroplasty. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects must be diagnosed with either osteoarthritis or traumatic arthritis and be candidates for a primary total knee arthroplasty. They must also meet the indications for use for the 3DKnee system with the vitamin E tibial insert.
Key inclusion criteria (7 listed)
- Subject must be a candidate for a total primary knee replacement.
- Subject must have knee joint disease related to degenerative joint disease, including osteoarthritis or traumatic arthritis
- Subject has a BMI ≤ 40.00 kg/m2
- Subject is likely to be available for evaluation for the duration of the study
- Subject is able and willing to sign the informed consent and follow study procedures
Key exclusion criteria (15 listed)
- Subject has had a prior total or uni-knee replacement on this knee in the past (no revisions allowed in study)
- Subject has avascular necrosis of the femoral condyles, post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities or rheumatoid arthritis
- Subject has an active cancer or is a survivor for <5 years except for squamous cell or basal cell skin cancer
- Subject has a chronic disease(s) where, in the opinion of the investigator, the disease will interfere with the patient's ability to follow the protocol
- Subject is currently a documented substance abuser (alcohol or other addictions)
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™ System with Vitamin E UHMWPE Tibial InsertsThis device is part of a total knee replacement system utilized in treating patients who are candidates for primary cemented total knee arthroplasty or revision arthroplasty where bone loss is minimal and the collateral ligaments are intact. It is intended to aid the surgeon in relieving the patient of knee pain and restoring knee joint function. | Device | 3DKnee™ with e-plus Insert |
Primary outcome
Efficacy of the Vitamin E UHMWPE as part of the total knee system, measured by Knee Society Score Evaluation and total number of radiologic failures of the device.
Time frame: 2 year
The (American) Knee Society Score has both an objective and a functional component. The objective score takes into account pain, flexion, stability, alignment, extension lag and flexion contracture. Overall success will be defined as a KSS score ≥ 80 at two years. Radiolucencies have been defined as two types, with one type being more common than the other. In the case of physiologic radiolucency, which is the most common type of radiolucency seen, there is a narrow line present that is well-defined around the prosthesis. This line is surrounded by a radio-dense line and tends to consolidate (disappear) within the first year. The second type of radiolucency, the pathologic radiolucency, is rarer and is associated with loosening and infection. It is a progressive, poorly defined radiolucency that is more than 2 mm thick and without a radiolucent line.
5 secondary outcomes
Change in Knee Society Score from pre-surgery to 10 years
Time frame: 10 year
Change in WOMAC Osteoarthritis Index from pre-surgery to 10 years
Time frame: 10 year
Change in Oxford Knee Score from pre-surgery to 10 years
Time frame: 10 year
Change in response to Quality of Life questions from pre-surgery to 6 months and each year thereafter through 10 years
Time frame: 10 years
6. Change in pain from pre-surgery to 6 months and each year thereafter through 10 years
Time frame: 10 years
Results and safety
The study was stopped early (reason given: Lack of sufficient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 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 6 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 7 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: stopped early, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 was stopped early (reason given: Lack of sufficient enrollment). 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?
Efficacy of the Vitamin E UHMWPE as part of the total knee system, measured by Knee Society Score Evaluation and total number of radiologic failures of the device. (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 31 Mar 2022.