Total Knee ArthroplastyNCT02358434
ATTUNE TM Video-fluoroscopy Study
An observational study of Total Knee Arthroplasty, run by Dr. Renate List at 1 site in Switzerland.
Trial summary
The proposed study is a retrospective, observational study. A group of 5 subjects with the AttuneTM cruciate retaining (CR) fixed bearing total knee arthroplasty (TKA) are analysed during level walking, a deep knee bend, sitting down onto a chair, standing up from a chair and stair descent at least 12 months… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Observational use of fluoroscopy
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2015to Sep 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Prof. Dr. med. Carsten Perka will do the recruitment, since he is the surgeon that worked the most with this implant and therefore also has the biggest population of possibly eligible patients. Furthermore the patients already know and trust him, which could lead to a greater success in the recruitment as well. For these reasons the financial source DePuy Synthes, Johnson and Johnson, requires that the clinical collaborator Prof. Dr. med. Carsten Perka will do the recruitment. He works in the Charité in Berlin, Germany, where he does the recruitment.
Who may be able to join
- Unilateral TKA (ATTUNETM) due to osteoarthrosis (OA)
- Body mass index (BMI) ≤ 33
- Good clinical outcome, Knee injury and Osteoarthritis Outcome Score (KOOS) > 70
- No or very low Visual Analog Scale for Pain (VAS) < 2
- At least one year post-op
- Standardized general health survey score (SF-12) within the normal range for people in their age group
Who cannot join
- Actual significant problem on lower extremities
- Misaligned TKA
- Any other arthroplasty at the lower extremities
- Patient incapable to understand and sign informed consent
- Incapable of performing the motion tasks
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Institute for Biomechanics
Zurich, Canton of Zurich, 8093
About this study
Official title: Kinematics Analysis: Cruciate Retaining, Fixed Bearing Primary Total Knee Arthroplasty With the ATTUNE TM Knee System
The proposed study is a retrospective, observational study. A group of 5 subjects with the AttuneTM cruciate retaining (CR) fixed bearing total knee arthroplasty (TKA) are analysed during level walking, a deep knee bend, sitting down onto a chair, standing up from a chair and stair descent at least 12 months post-operatively, in terms of 3D fluoroscopic assessed tibio-femoral TKA motion as well as simultaneous skin marker assessed whole leg motion and ground reaction forces. The obtained information helps the manufacturer (DePuy) to evaluate, bring to market and advance the implant. Furthermore the information will be integrated in a model, which will be developed at the Center for Orthopaedic Engineering, University of Denver. By means of this model, different conditions such as the use of an advanced prosthesis design can be simulated and tested.
The objective of this study is in a first step to demonstrate the capability of data collection and analysis of level gait, deep knee bend, sitting down onto a chair, standing up from a chair and stair descent on a limited sample size of five subjects. Secondly to quantify and describe the three-dimensional kinematics for the cruciate retaining (CR), fixed bearing AttuneTM TKA during daily activities such as those mentioned.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Observational use of fluoroscopy
- Keywords
- Implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational use of fluoroscopyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between the knee flexion angle and the medial and lateral anterior-posterior translation of the condyles
The primary outcome of this pilot study is the relationship between the knee flexion angle and the medial and lateral anterior-posterior translation of the condyles during level walking, stair descent, standing up from a chair, sitting onto a chair and deep knee bend.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2015 (estimated)
- Study startJul 2015
- Primary completionMar 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Renate List
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Renate List, Institute for Biomechanics, ETH Zürich
- Investigators
- Renate List, PhD, Principal investigator, ETH Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358434
- Sponsor's protocol ID
- ATTUNE-2015
- Status last verified
- Jan 2017
- First submitted
- 4 Feb 2015
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinematics Analysis: Cruciate Retaining, Fixed Bearing Primary Total Knee Arthroplasty With the ATTUNE TM Knee System
- ClinicalTrials.gov ID
- NCT02358434
- Acronym / sponsor ID
- ATTUNE-2015
- Conditions
- Total Knee Arthroplasty
- Keywords
- Implant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Dr. Renate ListUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 9 Feb 2015 (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 proposed study is a retrospective, observational study. A group of 5 subjects with the AttuneTM cruciate retaining (CR) fixed bearing total knee arthroplasty (TKA) are analysed during level walking, a deep knee bend, sitting down onto a chair, standing up from a chair and stair descent at least 12 months post-operatively, in terms of 3D fluoroscopic assessed tibio-femoral TKA motion as well as simultaneous skin marker assessed whole leg motion and ground reaction forces. The obtained information helps the manufacturer (DePuy) to evaluate, bring to market and advance the implant. Furthermore the information will be integrated in a model, which will be developed at the Center for Orthopaedic Engineering, University of Denver. By means of this model, different conditions such as the use of an advanced prosthesis design can be simulated and tested.
The objective of this study is in a first step to demonstrate the capability of data collection and analysis of level gait, deep knee bend, sitting down onto a chair, standing up from a chair and stair descent on a limited sample size of five subjects. Secondly to quantify and describe the three-dimensional kinematics for the cruciate retaining (CR), fixed bearing AttuneTM TKA during daily activities such as those mentioned.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Prof. Dr. med. Carsten Perka will do the recruitment, since he is the surgeon that worked the most with this implant and therefore also has the biggest population of possibly eligible patients. Furthermore the patients already know and trust him, which could lead to a greater success in the recruitment as well. For these reasons the financial source DePuy Synthes, Johnson and Johnson, requires that the clinical collaborator Prof. Dr. med. Carsten Perka will do the recruitment. He works in the Charité in Berlin, Germany, where he does the recruitment.
Key inclusion criteria (6 listed)
- Unilateral TKA (ATTUNETM) due to osteoarthrosis (OA)
- Body mass index (BMI) ≤ 33
- Good clinical outcome, Knee injury and Osteoarthritis Outcome Score (KOOS) > 70
- No or very low Visual Analog Scale for Pain (VAS) < 2
- At least one year post-op
Key exclusion criteria (6 listed)
- Actual significant problem on lower extremities
- Misaligned TKA
- Any other arthroplasty at the lower extremities
- Patient incapable to understand and sign informed consent
- Incapable of performing the motion tasks
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 |
|---|---|---|
| Observational use of fluoroscopy | Radiation | – |
Primary outcome
Relationship between the knee flexion angle and the medial and lateral anterior-posterior translation of the condyles
Time frame: 3 hours
The primary outcome of this pilot study is the relationship between the knee flexion angle and the medial and lateral anterior-posterior translation of the condyles during level walking, stair descent, standing up from a chair, sitting onto a chair and deep knee bend.
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 26 Jan 2017.
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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.
Renate List, PhD principal investigator
ETH Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Arthroplasty, run by Dr. Renate List at 1 site in Switzerland.
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 6 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 26 Jan 2017. 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 Switzerland. 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?
Relationship between the knee flexion angle and the medial and lateral anterior-posterior translation of the condyles (time frame: 3 hours). 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 26 Jan 2017.