Osteoarthritis, KneeNCT02276118
Outcome Comparison of Two Total Knee Arthroplasty Systems: e.Motion-Pro Versus Genesis II
A study testing device: e.motion PS Pro and device : Genesis II in people with Osteoarthritis, Knee, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Recently, E.Motion-PS-Pro (B.Braun-Aesculap, Tuttlingen, Germany), a new mobile bearing knee system with a unique ball and socket post-cam mechanism was developed for use in total knee arthroplasty. Read more about this study
- Who is it for?
- Ages Up to 79 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- device: e.motion PS Pro and device : Genesis II
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2014to Dec 2015
- Phase
- Interventional
- 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 Up to 79 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients who are decided to undergo total knee arthroplasty with diagnosis of primary osteoarthritis
Who cannot join
- the diagnosis other than primary osteoarthritis
- previous history of infection or trauma requiring surgical treatment on the knee which will receive total knee arthroplasty
- patients of 80 years or older
- patients with systemic diseases that can affect functional outcomes of TKA
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Joint Reconstruction Center, Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Tae Kyun Kim, MD, PhD, 82-31-787-7196, osktk@snubh.org
Tae Kyun Kim, MD, PhD
About this study
Official title: Comparisons of Prosthesis Fitness, Early Recovery Patterns, Functional Outcomes and Patient Satisfaction Between E.Motion-Pro, a New Mobile Bearing System and Genesis II, an Established Successful System
Recently, E.Motion-PS-Pro (B.Braun-Aesculap, Tuttlingen, Germany), a new mobile bearing knee system with a unique ball and socket post-cam mechanism was developed for use in total knee arthroplasty. This study aims to determine (1) whether the use of E.Motion-PS-Pro improves prosthesis fitness for the femur and tibia in terms of under- or over-hang incidence compared to an established successful prosthesis, Genesis II (Smith \& Nephew, Memphis, U.S.A.), (2) whether patients with this new prosthesis experience less pain and faster wound healing in early recovery phase, (3) whether patients with E.Motion-Pro reach functional plateaus faster than patients with Genesis II and the functional plateaus of patients with E.Motion-Pro are higher than those of patients with Genesis II.
Read the detailed description
Total knee arthroplasty (TKA) is a satisfactory treatment option for patients with advanced knee diseases that are intractable with other modalities in terms of pain relief, functional restoration, and deformity correction. Unfortunately, however, many patients have to go through a recovery period of several months during which they experience considerable pain and suffer from incompletely restored functions. In recent years, to improve the quality of life during early recovery period after TKA, great efforts have been made in multiple areas including the use of minimally invasive surgical technique, improved pain management protocols, and postoperative rehabilitation protocols. Nonetheless, this almost inevitable presence of painful and disabling recovery period is a major concern to patients scheduled for or considering TKA as a treatment option. Furthermore, this issue can become a more serious obstacle to very elderly patients who have to balance the benefits of remaining years with improved functions from replaced knees and the burden of recovery duration after TKA.
In theory, the use of a better fitting prosthesis with sound kinematic performance can shorten the duration of recovery period and improve the quality of life by reducing pain and facilitating functional recovery. Better fitting prostheses allegedly less involve prosthesis overhang at femoral condylar level, which can cause impingement symptoms and at anterior flange area, which can cause patellofemoral symptoms. Prosthesis providing better kinematic performance such as natural motion and joint stability throughout motion arc can reduce pain and discomfort in early recovery period and shorten the duration of recovery period.
Recently, E.Motion-PS-Pro (B.Braun-Aesculap, Tuttlingen, Germany), a new mobile bearing knee system with a unique ball and socket post-cam mechanism was developed. This new prosthesis was designed to achieve better prosthesis fitting, to minimize bone loss from box preparations for post-cam mechanism, to improve joint stability throughout motion arc, particularly in high flexion, and to reduce the risk for wear and fracture at the post by increasing contact area. If the intended design rationales work out well, this prosthesis shall reduce soft tissue impingement and provide better kinematic performances, which reduces pain and facilitates functional restoration.
Therefore, the current investigators aim to determine (1) whether the use of E.Motion-PS-Pro improves prosthesis fitness for the femur and tibia in terms of under- or over-hang incidence compared to an established successful prosthesis, Genesis II (Smith \& Nephew, Memphis, U.S.A.), (2) whether patients with this new prosthesis experience less pain and faster wound healing in early recovery phase, (3) whether patients with E.Motion-Pro reach functional plateaus faster than patients with Genesis II and the functional plateaus of patients with E.Motion-Pro are higher than those of patients with Genesis II. The investigators hypothesize that (1) E.Motion-Pro reduces the incidence of prosthesis under- or over-hang, (2) patients with E.Motion-Pro experience less pain and faster wound healing in early recovery phase, and (3) patients with E.Motion-Pro reach functional plateau faster and the functional outcomes at 1 year are better in patients with E.Motion-Pro than those with Genesis II.
- Conditions
- Osteoarthritis, Knee
- Being tested
- device: e.motion PS Pro, device : Genesis II
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
device: e.motion PS ProDevice
patients will undergo total knee arthroplasty with e.motion PS Pro implant
device : Genesis IIDevice
patients will undergo total knee arthroplasty with Genesis II implant
| Study group | Role | What they receive |
|---|---|---|
| e.motion PS Pro group | Experimental | the patients who receives total knee arthroplasty with the e.motion PS pro prosthesis Receives: Device: device: e.motion PS Pro |
| Genesis II group | Active comparator | the patients who receives total knee arthroplasty with the Genesis II prosthesis Receives: Device: device : Genesis II |
What is being measured
The primary outcome is the main question the study is designed to answer.
prosthesis fit
Component fitness will be evaluated by whether there is overhang (too wide or big) or underhang (too narrow or small) more than 2 mm at any of three sites: condyle, junction, and anterior flange
Measured: from the start to end of surgery (expected average of 90 minutes)
pain level during gait at 3 months after surgery
Pain levels will be evaluated by asking how much pain patients feel during weight bearing gait at 3 months in 0-10 visual analog scale (0-no pain and 10-maximum pain)
Measured: at 3 months after surgery
knee swelling (circumference measured at the knee) at 3 months
Knee swelling will be evaluated by measuring the leg circumference at the knee level (mid-patella), and the measured circumference will be compared with the preoperative circumference
Measured: at 3 months after surgery
flexion contracture and maximum flexion at 3 months
Flexion contracture and further flexion will be measured by a single investigator using a 38-cm clinical goniometer with patients supine
Measured: at 3 months after surgery
the new American Knee Society (AKS) score at 6 months
Patients will be evaluated at 6 months using the new scoring system of American Knee Society. The American Knee Society scoring system evaluates multiple aspects of outcomes: 1) Objective knee indicators (maximum points 80) - alignment (25), mediolateral (ML) stability (15), anteroposterior (AP) stability (10), range of motion (ROM) (30); 2) Knee score (maximum points 80) - symptoms (25), patient satisfaction (40), and expectation (15); 3) Function score (maximum points 100) - walking \& standing (30), standard activities (30), advanced activities (25), discretionary knee activities (15)
Measured: at 6 months after surgery
Secondary outcomes (10)
whether balanced gaps were achieved
Balanced gap achievement will be called when flexion-extension and medio-lateral gaps are not beyond 2 mm difference
Measured: from the start to end of surgery (expected average of 90 minutes)
tourniquet time
Tourniquet time will be measured as the duration in minutes from the point making skin incision to deflating tourniquet to check whether arterial bleeders are after implant fixation
Measured: from the start to end of surgery (expected average of 90 minutes)
blood volume drained via a vacuum drainage in the subcutaneous tissue
blood volume drained via a vacuum drainage will be measured as the total amount drained from the end of surgery to removal of vacuum drainage in mL.
Measured: from the end of surgery to removal of vacuum drainage (usually at 2 days after surgery)
hemoglobin drop on postoperative 2 and 5 days
hemoglobin drop on the 2nd and 5th postoperative days will be evaluated by subtracting hemoglobin level on the 2nd or 5th day from the preoperative level.
Measured: at 2 and 5 days after surgery
pain level during motion arc exercise at 2 and 6 weeks
Pain levels during motion arc exercise will be evaluated at 2 and 6 weeks using 0-10 Visual Analogue Scale.
Measured: at 2 and 6 weeks after surgery
knee swelling at 2 and 6 weeks
knee swelling will be evaluated at 2 and 6 weeks by noting the leg circumference at the mid-patella level
Measured: at 2 and 6 weeks after surgery
need for walking aid at 6 weeks
Whether patients still need a walking aid (yes/no) will be noted at 6 weeks
Measured: at 6 weeks after surgery
patient satisfaction with early recovery pattern at 3 months
Patient satisfaction with early recovery pattern will be evaluated at 3 month using a 0-4 Likert scales (0-disappointed, 1-less satisfactory than expected, 2 - as expected, 3- more satisfactory than expected, 4 - extremely satisfactory)
Measured: at 3months after surgery
flexion contracture and further flexion at 6 weeks, and 6, 12, 24 months
Motion arc will be evaluated in extension deficit (flexion contracture) and maximum flexion at 6 weeks, 6 months, 12 months, and 2 years
Measured: at 6 weeks, and 6, 12, 24 months after surgery
patient satisfaction with replaced knees at 12 and 24 months
Patients will be evaluated for their satisfaction with replaced knees at 12 and 24 months after surgery with 0-4 Likert scale and 0-10 Visual analogue scale.
Measured: at 12 and 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tae Kyun Kim, MD, PhD, Study chair, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02276118
- Sponsor's protocol ID
- E-1406/254-001
- Status last verified
- Jul 2014
- First submitted
- 19 Oct 2014
- Last updated
- 27 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparisons of Prosthesis Fitness, Early Recovery Patterns, Functional Outcomes and Patient Satisfaction Between E.Motion-Pro, a New Mobile Bearing System and Genesis II, an Established Successful System
- ClinicalTrials.gov ID
- NCT02276118
- Acronym / sponsor ID
- E-1406/254-001
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 27 Oct 2014 (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.
Recently, E.Motion-PS-Pro (B.Braun-Aesculap, Tuttlingen, Germany), a new mobile bearing knee system with a unique ball and socket post-cam mechanism was developed for use in total knee arthroplasty. This study aims to determine (1) whether the use of E.Motion-PS-Pro improves prosthesis fitness for the femur and tibia in terms of under- or over-hang incidence compared to an established successful prosthesis, Genesis II (Smith \& Nephew, Memphis, U.S.A.), (2) whether patients with this new prosthesis experience less pain and faster wound healing in early recovery phase, (3) whether patients with E.Motion-Pro reach functional plateaus faster than patients with Genesis II and the functional plateaus of patients with E.Motion-Pro are higher than those of patients with Genesis II.
Detailed description
Total knee arthroplasty (TKA) is a satisfactory treatment option for patients with advanced knee diseases that are intractable with other modalities in terms of pain relief, functional restoration, and deformity correction. Unfortunately, however, many patients have to go through a recovery period of several months during which they experience considerable pain and suffer from incompletely restored functions. In recent years, to improve the quality of life during early recovery period after TKA, great efforts have been made in multiple areas including the use of minimally invasive surgical technique, improved pain management protocols, and postoperative rehabilitation protocols. Nonetheless, this almost inevitable presence of painful and disabling recovery period is a major concern to patients scheduled for or considering TKA as a treatment option. Furthermore, this issue can become a more serious obstacle to very elderly patients who have to balance the benefits of remaining years with improved functions from replaced knees and the burden of recovery duration after TKA.
In theory, the use of a better fitting prosthesis with sound kinematic performance can shorten the duration of recovery period and improve the quality of life by reducing pain and facilitating functional recovery. Better fitting prostheses allegedly less involve prosthesis overhang at femoral condylar level, which can cause impingement symptoms and at anterior flange area, which can cause patellofemoral symptoms. Prosthesis providing better kinematic performance such as natural motion and joint stability throughout motion arc can reduce pain and discomfort in early recovery period and shorten the duration of recovery period.
Recently, E.Motion-PS-Pro (B.Braun-Aesculap, Tuttlingen, Germany), a new mobile bearing knee system with a unique ball and socket post-cam mechanism was developed. This new prosthesis was designed to achieve better prosthesis fitting, to minimize bone loss from box preparations for post-cam mechanism, to improve joint stability throughout motion arc, particularly in high flexion, and to reduce the risk for wear and fracture at the post by increasing contact area. If the intended design rationales work out well, this prosthesis shall reduce soft tissue impingement and provide better kinematic performances, which reduces pain and facilitates functional restoration.
Therefore, the current investigators aim to determine (1) whether the use of E.Motion-PS-Pro improves prosthesis fitness for the femur and tibia in terms of under- or over-hang incidence compared to an established successful prosthesis, Genesis II (Smith \& Nephew, Memphis, U.S.A.), (2) whether patients with this new prosthesis experience less pain and faster wound healing in early recovery phase, (3) whether patients with E.Motion-Pro reach functional plateaus faster than patients with Genesis II and the functional plateaus of patients with E.Motion-Pro are higher than those of patients with Genesis II. The investigators hypothesize that (1) E.Motion-Pro reduces the incidence of prosthesis under- or over-hang, (2) patients with E.Motion-Pro experience less pain and faster wound healing in early recovery phase, and (3) patients with E.Motion-Pro reach functional plateau faster and the functional outcomes at 1 year are better in patients with E.Motion-Pro than those with Genesis II.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| e.motion PS Pro group | Experimental | Device: device: e.motion PS Prothe patients who receives total knee arthroplasty with the e.motion PS pro prosthesis |
| Genesis II group | Active comparator | Device: device : Genesis IIthe patients who receives total knee arthroplasty with the Genesis II prosthesis |
Who may qualify
- Ages
- Up to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients who are decided to undergo total knee arthroplasty with diagnosis of primary osteoarthritis
Key exclusion criteria (4 listed)
- the diagnosis other than primary osteoarthritis
- previous history of infection or trauma requiring surgical treatment on the knee which will receive total knee arthroplasty
- patients of 80 years or older
- patients with systemic diseases that can affect functional outcomes of TKA
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 |
|---|---|---|
| device: e.motion PS Propatients will undergo total knee arthroplasty with e.motion PS Pro implant | Device | e.motion PS Pro group |
| device : Genesis IIpatients will undergo total knee arthroplasty with Genesis II implant | Device | Genesis II group |
Primary outcome
prosthesis fit
Time frame: from the start to end of surgery (expected average of 90 minutes)
Component fitness will be evaluated by whether there is overhang (too wide or big) or underhang (too narrow or small) more than 2 mm at any of three sites: condyle, junction, and anterior flange
pain level during gait at 3 months after surgery
Time frame: at 3 months after surgery
Pain levels will be evaluated by asking how much pain patients feel during weight bearing gait at 3 months in 0-10 visual analog scale (0-no pain and 10-maximum pain)
knee swelling (circumference measured at the knee) at 3 months
Time frame: at 3 months after surgery
Knee swelling will be evaluated by measuring the leg circumference at the knee level (mid-patella), and the measured circumference will be compared with the preoperative circumference
flexion contracture and maximum flexion at 3 months
Time frame: at 3 months after surgery
Flexion contracture and further flexion will be measured by a single investigator using a 38-cm clinical goniometer with patients supine
the new American Knee Society (AKS) score at 6 months
Time frame: at 6 months after surgery
Patients will be evaluated at 6 months using the new scoring system of American Knee Society. The American Knee Society scoring system evaluates multiple aspects of outcomes: 1) Objective knee indicators (maximum points 80) - alignment (25), mediolateral (ML) stability (15), anteroposterior (AP) stability (10), range of motion (ROM) (30); 2) Knee score (maximum points 80) - symptoms (25), patient satisfaction (40), and expectation (15); 3) Function score (maximum points 100) - walking \& standing (30), standard activities (30), advanced activities (25), discretionary knee activities (15)
10 secondary outcomes
whether balanced gaps were achieved
Time frame: from the start to end of surgery (expected average of 90 minutes)
tourniquet time
Time frame: from the start to end of surgery (expected average of 90 minutes)
blood volume drained via a vacuum drainage in the subcutaneous tissue
Time frame: from the end of surgery to removal of vacuum drainage (usually at 2 days after surgery)
hemoglobin drop on postoperative 2 and 5 days
Time frame: at 2 and 5 days after surgery
pain level during motion arc exercise at 2 and 6 weeks
Time frame: at 2 and 6 weeks after surgery
knee swelling at 2 and 6 weeks
Time frame: at 2 and 6 weeks after surgery
need for walking aid at 6 weeks
Time frame: at 6 weeks after surgery
patient satisfaction with early recovery pattern at 3 months
Time frame: at 3months after surgery
flexion contracture and further flexion at 6 weeks, and 6, 12, 24 months
Time frame: at 6 weeks, and 6, 12, 24 months after surgery
patient satisfaction with replaced knees at 12 and 24 months
Time frame: at 12 and 24 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2014.
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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.
Tae Kyun Kim, MD, PhD study chair
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing device: e.motion PS Pro and device : Genesis II in people with Osteoarthritis, Knee, run by Seoul National University Hospital at 1 site in South Korea.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 27 Oct 2014. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tae Kyun Kim, MD, PhD (82-31-787-7196, osktk@snubh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prosthesis fit (time frame: from the start to end of surgery (expected average of 90 minutes)). The study lists 5 primary outcomes in all. 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 27 Oct 2014.