GonarthrosisDePuyAttuneNCT02251535
In-vivo Comparison of Different Levels of Femoral Rollback in a Primary Total Knee Arthroplasty
A study testing ATTUNE® Knee System and PFC® SIGMA® Knee System in people with Gonarthrosis, run by Prof. Dr. Carsten Perka at 1 site in Germany.
Trial summary
Retrospective non-randomized in-vivo comparison of different levels of femoral rollback in the ATTUNE total knee arthroplasiy system (rotating platform CR high level roll back vs. rotating platform CR low level roll back) on the basis of fluoroscopic and marker-based motion capture evaluation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gonarthrosis
- What is being tested?
- ATTUNE® Knee System and PFC® SIGMA® Knee System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2014to Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gender: Both, male and female
- MinimumAge: 18 Years
- Osteoarthritis Kellgren Grad lll or lV
- Mechanical leg axis between 10'valgus and 10' varus
- Tibial slope between 0' and 10'
- BMI< 40, participation consent
Who cannot join
- Multidirectional instability of the knee
- connective tissue diseases (Marfan syndrome, Ehlers-Danlos syndrome, scleroderma)
- Nervous system diseases (Parkinson, multiple sclerosis, Peripheral neuropathy)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charité University Medicine Berlin Center for Musculoskeletal Surgery Department of Orthopaedics
Berlin, State of Berlin, 10117
About this study
Official title: Retrospective Non-randomized In-vivo Comparison of Different Levels of Femoral Rollback in the ATTUNE Total Knee Arthroplasiy System on the Basis of Fluoroscopic and Marker-based Motion Capture Evaluation.
Retrospective non-randomized in-vivo comparison of different levels of femoral rollback in the ATTUNE total knee arthroplasiy system (rotating platform CR high level roll back vs. rotating platform CR low level roll back) on the basis of fluoroscopic and marker-based motion capture evaluation. How do different levels of intra-operatively observed femoral rollback correlate to postoperative kinematics under weight bearing conditions? Does the modified design of the Attune Knee System influence the extent of the femoral rollback compared to the PFC Sigma Knee System? Does the femoral rollback maintain over a period of 12 months follow up or is it reduced by, for example, remodelling of the posterior cruciate ligament?
Read the detailed description
Postoperative knee pain is one of the most challenging problems following total knee arthroplasty. Of all the possible complications, the patella-femoral joint is an important cause of postoperative knee pain and prosthetic failure. Nägerl et al. observed that the tibia slides along the femoral surface when the knee is flexed [Nagerlet al., 2009]. Beside the stabilization of the flexion gap, the main task of the posterior cruciate ligament is to initiate the femoral rollback to reduce the patellofemoral pressure. Vice versa, Heyse et al. could show that the patello-femoral pressure rises with the nsuffictency of the posterior cruciate ligament [Heyse et al., 2010]. Pandit et al. measured the physiological rollback in healthy knees and following implantation of currently available TKA. They could show that bonventional TKA are not able to restore the rollback in the natural tibio-femoral joint [Pandit et al., 2005]. Thus it would be important to see if the knee stability in joint replacement reaches the one found in intact or reconstructed knees after surgery. To mimic the femoral rollback a new prosthesis has recently been developed and is about to be introduced to be a new option for total knee arthroplasty. The "Attune Knee System" (DePuy, Warsaw, USA) also has a reduced femoral flange to reduce the patella-femoral contact pressure. The increased rotational stability, the reduced femoral flange and the femoral rollback of the "Attune Knee System" are intended to decrease postoperative knee pain. Different levels of femoral rollback were observed intra-operatively between the Attune and PFC Sigma system. Yoshiya et al. could show the relation between the posterior cruciate ligament with the femoral rollback [Yoshiya et al. 2005]. Therefore, one can hypothesize that different implant designs in combination with the tension of the PCL produce different extents of femoral rollback, ln order to test in-vivo knee kinematics in patients during active movements, we use motion capture, together with combinations of advanced techniques for assessing skeletal kinematics (including sARA [Ehrig et a1.2007], SCoRE [Ehrig et al.2011] \& ocsr [Taytor et at. 2005]), a novet non-invasive approach to evaluate dynamic tibio-femoral motion. The combination of these approaches is now able to provide the accuracy and sensitivity required to analyze movement patterns in a rapid, robust and therefore clinically viable manner. ln order to do so, highly advanced equipment is needed which is available in our laboratory in the Julius Wolff lnstitute. Here, we use an infra-red optical motion capture system (10 T20S cameras, Vicon, Oxford, UK; system accuracy \-0.3-0.5 mm), tracked at120Hz, as well as 2 force plates (AMTI 0R6, Watertown, MA, USA) in order to assess the external forces while performing active movements. With this methodology we are then able to measure the kinematics as well as kinetics in the knee joint [Boeth et al., 2013], especially different levels of femoral rollback in patients with ATTUNE implants, during activities of daily living including walking, jogging, stair ascending/descending, rise a chair, sit down. Furthermore lunge can also be performed with single plane fluoroscopy (BV Pulsera, Philips) with a frequency of 30 Hz. During these measurements, the different extents of femoral rollback in deep flexion (at 105'-125') under weight bearing condiiions will be assessed and compared to the Sigma PFC system. The contact point between the femoral component and the polyethylene inlay will be recorded and compared to standardized postoperative radiographs. Clear specification should be given to the subject in order to avoid unnecessary radiation, for this, at least 3 repetitions without radiation should be performed to guarantee a complete subject's understanding of the procedure. The final position of the foot on the sieps is marked to guarantee a standardization of the procedure. The height of the c-arm of the device is adjusted to the specific shank's height of the subject. During the analysis of the fluoroscopic assessment, model-based RSA software (MEDIS, Leiden, The Netherlands) is used to register CAD models of the meiallic implants to the fluoroscopic images, a registration accuracy of 0.6mm and 0.4' has been reported [Moewis elal.2012].
- Conditions
- Gonarthrosis
- Being tested
- ATTUNE® Knee System, PFC® SIGMA® Knee System
- Keywords
- kinematic analysis, femoral rollback, mobile bearing, cruciate retaining Primary Total Knee Arthroplasty
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATTUNE® Knee SystemDevice
PFC® SIGMA® Knee SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| test group 1 | Experimental | Retrospective test group 1 (n=10, ATTUNE® Knee System, rotating platform, cruciate retaining) with intraoperative high level rollback Receives: Device: ATTUNE® Knee System |
| test group 2 | Experimental | Retrospective test group 2 (n=10, ATTUNE® Knee System, rotating platform, cruciate retaining)with intraoperative low level rollback Receives: Device: ATTUNE® Knee System |
| control group | Experimental | Control group (n=10, PFC® SIGMA® Knee System, rotatinq platform, cruciate retaininq) Receives: Device: PFC® SIGMA® Knee System |
What is being measured
The primary outcome is the main question the study is designed to answer.
tibio-femoral anterior-posterior translation
We intend to collect tibio-femoral anterior-posterior translation during active movement in order to analyse the different extent of femoral rollback (fluoroscopy and gait analysis including lunge activity) at 12 months post operative. Therefore, the femoral rollback will be classified to high level (l) and low level (ll) according to intraoperatively documented findings and postoperative radiographs.
Measured: at 12 months post operative
Secondary outcomes (4)
quality of life
We intend to collect the following secondary objective data pre operatively and '12 months post operative:
- PKIP
Measured: at 12 months post operative
quality of life
We intend to collect the following secondary objective data pre operatively and '12 months post operative:
- KOOS
Measured: at 12 months post operative
quality of life
We intend to collect the following secondary objective data pre operatively and '12 months post operative:
- WOMAC
Measured: at 12 months post operative
quality of life
We intend to collect the following secondary objective data pre operatively and '12 months post operative:
- SF 36
Measured: at 12 months post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2014 (estimated)
- Study startJul 2014
- Primary completionApr 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GonarthrosisStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Carsten Perka
- Sponsor type
- University, hospital or other
- Collaborators
- Julius Wolff Institute
- Responsible party
- Sponsor-investigator, Prof. Dr. Carsten Perka, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02251535
- Sponsor's protocol ID
- DePuy ECO257107
- Acronym
- DePuyAttune
- Status last verified
- Sep 2014
- First submitted
- 23 Sep 2014
- Last updated
- 29 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Non-randomized In-vivo Comparison of Different Levels of Femoral Rollback in the ATTUNE Total Knee Arthroplasiy System on the Basis of Fluoroscopic and Marker-based Motion Capture Evaluation.
- ClinicalTrials.gov ID
- NCT02251535
- Acronym / sponsor ID
- DePuyAttune / DePuy ECO257107
- Conditions
- Gonarthrosis
- Keywords
- kinematic analysis, femoral rollback, mobile bearing, cruciate retaining Primary Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Prof. Dr. Carsten PerkaUniversity, hospital or other
- Collaborators
- Julius Wolff Institute
- Study start
- Jul 2014
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 29 Sep 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.
Retrospective non-randomized in-vivo comparison of different levels of femoral rollback in the ATTUNE total knee arthroplasiy system (rotating platform CR high level roll back vs. rotating platform CR low level roll back) on the basis of fluoroscopic and marker-based motion capture evaluation. How do different levels of intra-operatively observed femoral rollback correlate to postoperative kinematics under weight bearing conditions? Does the modified design of the Attune Knee System influence the extent of the femoral rollback compared to the PFC Sigma Knee System? Does the femoral rollback maintain over a period of 12 months follow up or is it reduced by, for example, remodelling of the posterior cruciate ligament?
Detailed description
Postoperative knee pain is one of the most challenging problems following total knee arthroplasty. Of all the possible complications, the patella-femoral joint is an important cause of postoperative knee pain and prosthetic failure. Nägerl et al. observed that the tibia slides along the femoral surface when the knee is flexed [Nagerlet al., 2009]. Beside the stabilization of the flexion gap, the main task of the posterior cruciate ligament is to initiate the femoral rollback to reduce the patellofemoral pressure. Vice versa, Heyse et al. could show that the patello-femoral pressure rises with the nsuffictency of the posterior cruciate ligament [Heyse et al., 2010]. Pandit et al. measured the physiological rollback in healthy knees and following implantation of currently available TKA. They could show that bonventional TKA are not able to restore the rollback in the natural tibio-femoral joint [Pandit et al., 2005]. Thus it would be important to see if the knee stability in joint replacement reaches the one found in intact or reconstructed knees after surgery. To mimic the femoral rollback a new prosthesis has recently been developed and is about to be introduced to be a new option for total knee arthroplasty. The "Attune Knee System" (DePuy, Warsaw, USA) also has a reduced femoral flange to reduce the patella-femoral contact pressure. The increased rotational stability, the reduced femoral flange and the femoral rollback of the "Attune Knee System" are intended to decrease postoperative knee pain. Different levels of femoral rollback were observed intra-operatively between the Attune and PFC Sigma system. Yoshiya et al. could show the relation between the posterior cruciate ligament with the femoral rollback [Yoshiya et al. 2005]. Therefore, one can hypothesize that different implant designs in combination with the tension of the PCL produce different extents of femoral rollback, ln order to test in-vivo knee kinematics in patients during active movements, we use motion capture, together with combinations of advanced techniques for assessing skeletal kinematics (including sARA [Ehrig et a1.2007], SCoRE [Ehrig et al.2011] \& ocsr [Taytor et at. 2005]), a novet non-invasive approach to evaluate dynamic tibio-femoral motion. The combination of these approaches is now able to provide the accuracy and sensitivity required to analyze movement patterns in a rapid, robust and therefore clinically viable manner. ln order to do so, highly advanced equipment is needed which is available in our laboratory in the Julius Wolff lnstitute. Here, we use an infra-red optical motion capture system (10 T20S cameras, Vicon, Oxford, UK; system accuracy \-0.3-0.5 mm), tracked at120Hz, as well as 2 force plates (AMTI 0R6, Watertown, MA, USA) in order to assess the external forces while performing active movements. With this methodology we are then able to measure the kinematics as well as kinetics in the knee joint [Boeth et al., 2013], especially different levels of femoral rollback in patients with ATTUNE implants, during activities of daily living including walking, jogging, stair ascending/descending, rise a chair, sit down. Furthermore lunge can also be performed with single plane fluoroscopy (BV Pulsera, Philips) with a frequency of 30 Hz. During these measurements, the different extents of femoral rollback in deep flexion (at 105'-125') under weight bearing condiiions will be assessed and compared to the Sigma PFC system. The contact point between the femoral component and the polyethylene inlay will be recorded and compared to standardized postoperative radiographs. Clear specification should be given to the subject in order to avoid unnecessary radiation, for this, at least 3 repetitions without radiation should be performed to guarantee a complete subject's understanding of the procedure. The final position of the foot on the sieps is marked to guarantee a standardization of the procedure. The height of the c-arm of the device is adjusted to the specific shank's height of the subject. During the analysis of the fluoroscopic assessment, model-based RSA software (MEDIS, Leiden, The Netherlands) is used to register CAD models of the meiallic implants to the fluoroscopic images, a registration accuracy of 0.6mm and 0.4' has been reported [Moewis elal.2012].
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| test group 1 | Experimental | Device: ATTUNE® Knee SystemRetrospective test group 1 (n=10, ATTUNE® Knee System, rotating platform, cruciate retaining) with intraoperative high level rollback |
| test group 2 | Experimental | Device: ATTUNE® Knee SystemRetrospective test group 2 (n=10, ATTUNE® Knee System, rotating platform, cruciate retaining)with intraoperative low level rollback |
| control group | Experimental | Device: PFC® SIGMA® Knee SystemControl group (n=10, PFC® SIGMA® Knee System, rotatinq platform, cruciate retaininq) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Gender: Both, male and female
- MinimumAge: 18 Years
- Osteoarthritis Kellgren Grad lll or lV
- Mechanical leg axis between 10'valgus and 10' varus
- Tibial slope between 0' and 10'
Key exclusion criteria (4 listed)
- Multidirectional instability of the knee
- connective tissue diseases (Marfan syndrome, Ehlers-Danlos syndrome, scleroderma)
- Nervous system diseases (Parkinson, multiple sclerosis, Peripheral neuropathy)
- Pregnancy
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 |
|---|---|---|
| ATTUNE® Knee System | Device | test group 1, test group 2 |
| PFC® SIGMA® Knee System | Device | control group |
Primary outcome
tibio-femoral anterior-posterior translation
Time frame: at 12 months post operative
We intend to collect tibio-femoral anterior-posterior translation during active movement in order to analyse the different extent of femoral rollback (fluoroscopy and gait analysis including lunge activity) at 12 months post operative. Therefore, the femoral rollback will be classified to high level (l) and low level (ll) according to intraoperatively documented findings and postoperative radiographs.
4 secondary outcomes
quality of life
Time frame: at 12 months post operative
quality of life
Time frame: at 12 months post operative
quality of life
Time frame: at 12 months post operative
quality of life
Time frame: at 12 months post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2014.
- Center for Musculoskeletal SurgeryLink provided by the sponsor.
- Julius Wolff Institute for Biomechanics and Musculoskeletal RegenerationLink 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ATTUNE® Knee System and PFC® SIGMA® Knee System in people with Gonarthrosis, run by Prof. Dr. Carsten Perka at 1 site in Germany.
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 6 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 29 Sep 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 Germany. 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 Georg N. Duda, Prof. (+49 30 450 559 079, georg.duda@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tibio-femoral anterior-posterior translation (time frame: at 12 months post operative). 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 29 Sep 2014.