OsteoarthritisAttune-RSANCT02323386
Kinematic Analysis of a PS, FB Primary Total Knee Arthroplasty (ATTUNE Knee System) Using Dynamic RSA
A study testing Primary Total Knee Arthroplasty (ATTUNE Knee System) in people with Osteoarthritis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
Background: Across the European Union there are 535,000 Total Knee Arthroplasty (TKA)per year. Statistics indicate that for patients over 60 year old approximately one out of 20 will require corrective reoperations within 10 years after surgery. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Primary Total Knee Arthroplasty (ATTUNE Knee System)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2015to Sep 2016
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe radiographic osteoarthritis (Kellgren-Lawrence grade >3)
- Patients scheduled for a primary TKA
- Willing to take part in study and providing HIPAA authorization
Who cannot join
- Previous corrective osteotomy on the affected lower limb
- Post-traumatic arthritis
- Severe preoperative valgus deformity (Hip Knee Ankle angle>10°)
- BMI>40 kg/m2
- Rheumatoid arthritis
- Chronic inflammatory joint diseases
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- Patients with a pre-pathological abnormal gait (amputated, neuromuscular disorders, poliomyelitis, developmental dysplasia of the hip)
- Severe ankle osteoarthritis (Kellgren-Lawrence>3)
- Severe hip osteoarthritis (Kellgren-Lawrence>3)
- Previous total hip or ankle replacement
- Unwilling to take part in study and providing HIPAA authorization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anatomo-functional Correlation Between Intra-operative Passive Kinematics Recorded by Navigation and Post-operative Kinematics Analyzed by Dynamic Weight Bearing RSA of the Operated Knee.
Background: Across the European Union there are 535,000 Total Knee Arthroplasty (TKA)per year. Statistics indicate that for patients over 60 year old approximately one out of 20 will require corrective reoperations within 10 years after surgery. However, for patients younger than 60 years, approximately one out of 10 will require revision total knee arthroplasty within 10 years of surgery. As the number of younger patients is increasing, there has been a shift in focus in total Knee Replacement (TKR) outcome, with post-operative function and implant longevity being the important issues for quality of patient care. Furthermore, it has been reported that up to 25% of patients are not satisfied with the functional results of their TKA. In vivo the gold standard for obtaining reliable 3D measurements is RSA. However these are often static, because of even most advanced x-ray film exchanger limit the number of pictures taken to less than 10 per second. Our dynamic RSA technique allows producing real time x-ray video of TKA in weight-bearing (WB) conditions with active muscle contraction.
The purpose of this study is to investigate the effect of a new implant design on the post-operative active knee kinematics, focusing on mid-flexion instability of the joint. A prospective randomized study will be performed on a new implant: the DePuy ATTUNETM fixed-bearing (FB) posterior-stabilized (PS) knee prosthesis.
Read the detailed description
The main goal of this study is to investigate the effect of a new implant design on the postoperative active knee kinematics on mid-flexion instability of the joint. Data will be collected during the surgery with a Computer Assisted Surgery system and in the post operative follow up phase using the dynamic RSA focusing. A prospective study will be performed on a new implant: the DePuy ATTUNETM fixed-bearing (FB) posterior-stabilized (PS) knee prosthesis.
Kinematic tests will be performed to analyze femoral rotation patterns and translation patterns of the medial and femoral condyle respect to the tibial plateau during different daily life motor tasks.
Despite reportedly good implant survival rates, not all patients are fully satisfied after total knee arthroplasty (TKA). One of the most debated topics in TKA is the effectiveness of the prosthesis to reproduce physiological kinematics at the replaced knee, usually expressed in terms of patterns of joint rotation in the three anatomical planes, of the functional axis, and of the tibio-femoral contact points on the medial and lateral condyles, that is, femoral roll-back.
Implant design can influence final kinematic results. The mid-flexion instability may be the cause of joint instability, paradoxical femoral rollback, surgical variation.
Recently an improved implant design of fixed bearing PS DePuy implant has been anticipated to early users. This implant has been claimed to reduce midflexion instability and improve joint kinematics, because of a particular multiradius shape of the condylar surface.
For intra-operative kinematic acquisition, a commercial navigation system (BLUIGS, Orthokey Italia srl, Firenze, Italy) with a dedicated software for kinematic tests will be used.
In the present study, the investigators will use a postoperative bi-planar imaging method in weight-bearing motor tasks with active muscle contraction , to determine the in vivo contact areas on the tibial articulating surface of a PS TKA during flexion of the knee.
The objective of the present study is to determine the contact areas and their movement through a 0-140° arc of motion in both the anteroposterior (AP) and ML directions. The cohort will also be compared with data of normal knee kinematics, as reported in current literature.
At 6 months follow-up, dynamic fluoroscopy will be used to analyze implant kinematics (i.e. stair descent, level-walking and non weight-bearing maximum knee flexion) and a simultaneous, real-time collection of ground reaction forces with a force platform will be performed. Clinical scores will be collected at that time and compared with all the data registered before surgery and during the follow up routinely made at 1 and 3 months after surgery.
A specifically developed device installed at the Rizzoli Orthopaedic Institute will be used to assess the kinematic of the knee at 9 months after surgery. This equipment is unique worldwide: it was specifically designed, built and certified for dynamic and static RSA evaluation of TKA. The purpose of this study is to investigate the effect of a new implant design on the post-operative active knee kinematics, focusing on mid-flexion instability of the joint. A prospective randomized study will be performed on a new implant: the DePuy ATTUNETM fixed-bearing (FB) posterior-stabilized (PS) knee prosthesis.
- Conditions
- Osteoarthritis
- Being tested
- Primary Total Knee Arthroplasty (ATTUNE Knee System)
- Keywords
- Dynamic RSA, Knee, Total Knee Arthroplasty, Kinematic Analysis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Total Knee Arthroplasty (ATTUNE Knee System)Device
The patient will undergo primary Total Knee ArthroplastY use ATTUNE Knee System. During surgery a navigation system will be used to record preoperative joint kinematics under different tests. During the test the 6 degrees of freedom (DOF) of the joint will be computed and shown to the surgeon; these are the femoral rotation and translation pattern against flexion ranges. Navigation system will be also used to monitor the implant positioning and possible surgical bias. Dynamic RSA will be used to analyze the in vivo kinematics of the prosthesis at 6 months follow-up.
The above mentioned motion tests will be performed 3 times. The first 2 will be executed to gain comfort with the experimental set-up with no X-ray exposure. During the last data is collected.
| Study group | Role | What they receive |
|---|---|---|
| ATTUNE knee system | Experimental | The patients will undergo primary Total Knee Arthroplasty (ATTUNE knee system) Receives: Device: Primary Total Knee Arthroplasty (ATTUNE Knee System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the femoral rotations and translations during weight-bearing motor tasks with active muscle contraction: step descent, full flexion movement, level walking.
The joint kinematic was acquired using the dynamic RSA technique. The rotations (angular degree) and translations (millimeter) were evaluated using the Euler decomposition and the Low-point algorithm.
Measured: 9 months
Secondary outcomes (2)
Correlation of clinical reported results (KSS, Oxford, SF36, WOMAC) and patients' subjective satisfaction using a visual analogue scale (VAS) with kinematics differences and ground reaction forces.
KSS, OXFORD, SF36, WOMAC, VAS scores will be assessed and recorded pre-operatively and post operatively at 6 months after surgery
Measured: 9 months
Quantification the ground reaction forces during weight-bearing motor tasks with active muscle contraction: step descent, full flexion movement, level walking.
Forces (newton N)
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionJul 2015
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy International
- Responsible party
- Principal investigator, Stefano Zaffagnini, Istituto Ortopedico Rizzoli
- Investigators
- Maurilio Marcacci, MD, Principal investigator, Rizzoli Orthopaedic InstituteLaura Bragonzoni, SportScience, Study director, Alma Mater Studiorum - University of BolognaDanilo Danilo, MD, Study chair, Rizzoli Orthopaedic InstituteBontempi Marco, Physicist, Study director, Rizzoli Orthopaedic InstituteMaria Pia Neri, MD, Study chair, Rizzoli Orthopaedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02323386
- Sponsor's protocol ID
- 46/13
- Acronym
- Attune-RSA
- Status last verified
- May 2018
- First submitted
- 10 Dec 2014
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: The IPd are to be shared by papers
Publications
Di Paolo S, Agostinone P, Grassi A, Lucidi GA, Pinelli E, Bontempi M, Marchiori G, Bragonzoni L, Zaffagnini S. Dynamic Radiostereometry Evaluation of 2 Different Anterior Cruciate Ligament Reconstruction Techniques During a Single-Leg Squat. Orthop J Sports Med. 2021 Jul 15;9(7):23259671211011940. doi: 10.1177/23259671211011940. eCollection 2021 Jul.
PubMed 34350300
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomo-functional Correlation Between Intra-operative Passive Kinematics Recorded by Navigation and Post-operative Kinematics Analyzed by Dynamic Weight Bearing RSA of the Operated Knee.
- ClinicalTrials.gov ID
- NCT02323386
- Acronym / sponsor ID
- Attune-RSA / 46/13
- Conditions
- Osteoarthritis
- Keywords
- Dynamic RSA, Knee, Total Knee Arthroplasty, Kinematic Analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Collaborators
- DePuy International
- Study start
- Jan 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 23 Dec 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.
Background: Across the European Union there are 535,000 Total Knee Arthroplasty (TKA)per year. Statistics indicate that for patients over 60 year old approximately one out of 20 will require corrective reoperations within 10 years after surgery. However, for patients younger than 60 years, approximately one out of 10 will require revision total knee arthroplasty within 10 years of surgery. As the number of younger patients is increasing, there has been a shift in focus in total Knee Replacement (TKR) outcome, with post-operative function and implant longevity being the important issues for quality of patient care. Furthermore, it has been reported that up to 25% of patients are not satisfied with the functional results of their TKA. In vivo the gold standard for obtaining reliable 3D measurements is RSA. However these are often static, because of even most advanced x-ray film exchanger limit the number of pictures taken to less than 10 per second. Our dynamic RSA technique allows producing real time x-ray video of TKA in weight-bearing (WB) conditions with active muscle contraction.
The purpose of this study is to investigate the effect of a new implant design on the post-operative active knee kinematics, focusing on mid-flexion instability of the joint. A prospective randomized study will be performed on a new implant: the DePuy ATTUNETM fixed-bearing (FB) posterior-stabilized (PS) knee prosthesis.
Detailed description
The main goal of this study is to investigate the effect of a new implant design on the postoperative active knee kinematics on mid-flexion instability of the joint. Data will be collected during the surgery with a Computer Assisted Surgery system and in the post operative follow up phase using the dynamic RSA focusing. A prospective study will be performed on a new implant: the DePuy ATTUNETM fixed-bearing (FB) posterior-stabilized (PS) knee prosthesis.
Kinematic tests will be performed to analyze femoral rotation patterns and translation patterns of the medial and femoral condyle respect to the tibial plateau during different daily life motor tasks.
Despite reportedly good implant survival rates, not all patients are fully satisfied after total knee arthroplasty (TKA). One of the most debated topics in TKA is the effectiveness of the prosthesis to reproduce physiological kinematics at the replaced knee, usually expressed in terms of patterns of joint rotation in the three anatomical planes, of the functional axis, and of the tibio-femoral contact points on the medial and lateral condyles, that is, femoral roll-back.
Implant design can influence final kinematic results. The mid-flexion instability may be the cause of joint instability, paradoxical femoral rollback, surgical variation.
Recently an improved implant design of fixed bearing PS DePuy implant has been anticipated to early users. This implant has been claimed to reduce midflexion instability and improve joint kinematics, because of a particular multiradius shape of the condylar surface.
For intra-operative kinematic acquisition, a commercial navigation system (BLUIGS, Orthokey Italia srl, Firenze, Italy) with a dedicated software for kinematic tests will be used.
In the present study, the investigators will use a postoperative bi-planar imaging method in weight-bearing motor tasks with active muscle contraction , to determine the in vivo contact areas on the tibial articulating surface of a PS TKA during flexion of the knee.
The objective of the present study is to determine the contact areas and their movement through a 0-140° arc of motion in both the anteroposterior (AP) and ML directions. The cohort will also be compared with data of normal knee kinematics, as reported in current literature.
At 6 months follow-up, dynamic fluoroscopy will be used to analyze implant kinematics (i.e. stair descent, level-walking and non weight-bearing maximum knee flexion) and a simultaneous, real-time collection of ground reaction forces with a force platform will be performed. Clinical scores will be collected at that time and compared with all the data registered before surgery and during the follow up routinely made at 1 and 3 months after surgery.
A specifically developed device installed at the Rizzoli Orthopaedic Institute will be used to assess the kinematic of the knee at 9 months after surgery. This equipment is unique worldwide: it was specifically designed, built and certified for dynamic and static RSA evaluation of TKA. The purpose of this study is to investigate the effect of a new implant design on the post-operative active knee kinematics, focusing on mid-flexion instability of the joint. A prospective randomized study will be performed on a new implant: the DePuy ATTUNETM fixed-bearing (FB) posterior-stabilized (PS) knee prosthesis.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ATTUNE knee system | Experimental | Device: Primary Total Knee Arthroplasty (ATTUNE Knee System)The patients will undergo primary Total Knee Arthroplasty (ATTUNE knee system) |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Severe radiographic osteoarthritis (Kellgren-Lawrence grade >3)
- Patients scheduled for a primary TKA
- Willing to take part in study and providing HIPAA authorization
Key exclusion criteria (11 listed)
- Previous corrective osteotomy on the affected lower limb
- Post-traumatic arthritis
- Severe preoperative valgus deformity (Hip Knee Ankle angle>10°)
- BMI>40 kg/m2
- Rheumatoid arthritis
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 |
|---|---|---|
| Primary Total Knee Arthroplasty (ATTUNE Knee System)The patient will undergo primary Total Knee ArthroplastY use ATTUNE Knee System. During surgery a navigation system will be used to record preoperative joint kinematics under different tests. During the test the 6 degrees of freedom (DOF) of the joint will be computed and shown to the surgeon; these are the femoral rotation and translation pattern against flexion ranges. Navigation system will be also used to monitor the implant positioning and possible surgical bias. Dynamic RSA will be used to analyze the in vivo kinematics of the prosthesis at 6 months follow-up. The above mentioned motion tests will be performed 3 times. The first 2 will be executed to gain comfort with the experimental set-up with no X-ray exposure. During the last data is collected. | Device | ATTUNE knee system |
Primary outcome
Evaluation of the femoral rotations and translations during weight-bearing motor tasks with active muscle contraction: step descent, full flexion movement, level walking.
Time frame: 9 months
The joint kinematic was acquired using the dynamic RSA technique. The rotations (angular degree) and translations (millimeter) were evaluated using the Euler decomposition and the Low-point algorithm.
2 secondary outcomes
Correlation of clinical reported results (KSS, Oxford, SF36, WOMAC) and patients' subjective satisfaction using a visual analogue scale (VAS) with kinematics differences and ground reaction forces.
Time frame: 9 months
Quantification the ground reaction forces during weight-bearing motor tasks with active muscle contraction: step descent, full flexion movement, level walking.
Time frame: 9 months
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 14 May 2018.
- Derived from this study: PubMed 34350300Di Paolo S, Agostinone P, Grassi A, Lucidi GA, Pinelli E, Bontempi M, Marchiori G, Bragonzoni L, Zaffagnini S. Dynamic Radiostereometry Evaluation of 2 Different Anterior Cruciate Ligament Reconstruction Techniques During a Single-Leg Squat. Orthop J Sports Med. 2021 Jul 15;9(7):23259671211011940. doi: 10.1177/23259671211011940. eCollection 2021 Jul.
- Individual participant dataSharing planned: No. The IPd are to be shared by papers
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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.
Maurilio Marcacci, MD principal investigator
Rizzoli Orthopaedic Institute
Laura Bragonzoni, SportScience study director
Alma Mater Studiorum - University of Bologna
Danilo Danilo, MD study chair
Rizzoli Orthopaedic Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary Total Knee Arthroplasty (ATTUNE Knee System) in people with Osteoarthritis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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 3 inclusion and 11 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 14 May 2018. 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 Italy. 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?
Evaluation of the femoral rotations and translations during weight-bearing motor tasks with active muscle contraction: step descent, full flexion movement, level walking. (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02323386, which also lists 1 linked publication.
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 14 May 2018.