Total Knee ReplacementNCT02706990
Fluoroscopic Analysis of Total Knee Replacement With a Kinematic Retaining or a Posterior Stabilized Design
A study testing Physica KR and Physica PS in people with Total Knee Replacement, run by Limacorporate S.p.a at 1 site in Italy.
Trial summary
The aim of this study is to evaluate the in vivo kinematics of TKA performed with two different prosthesis: a kinematic retaining (Physica KR) and a posterior-stabilized (Physica PS) design by means of fluoroscopic analysis during activities of daily living (rising from a chair, stairs climbing, leg extension). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- Physica KR and Physica PS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2016to Mar 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients submitted to Total knee arthroplasty (TKA) with Physica KR or PS;
- Patients with an appropriate initial fixation and stability of the knee prosthesis;
- Patients achieving a minimum flexion of 100° or a Knee Society Score (KSS) ≥ 65 (fair/good postoperative outcome) at 6-month follow-up;
- Patients affected by primary or secondary Osteoarthritis (OA) before surgery;
- Patients who understand the requirements of the study and are willing and able to comply with activities required for fluoroscopic examination;
- Patients who have signed the Ethics Committee approved study-specific Informed Consent Form.
Who cannot join
- Patients with misalignment or axial malrotation of the knee prosthesis;
- Patients not able to achieve a minimum flexion of 100° or with a KSS Knee Score ≤ 65 points at 6-month follow-up;
- Patients who had or have planned a surgery on their uninvolved knee within a year;
- Muscular insufficiency or absence of muscololigamentous supporting structures required for adequate soft tissue balance;
- Patients who have significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery and evaluation;
- Patients who have neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device;
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- Any psychiatric illness that would prevent comprehension of the details and nature of the study;
- Participation in any experimental drug/device study within the 6 months prior to the screening visit
- Female patients who are pregnant, nursing, or planning a pregnancy due to x-rays exposition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In Vivo Kinematic Analysis of Total Knee Replacement With a Kinematic Retaining or a Posterior Stabilized Design During Activities of Daily Living
The aim of this study is to evaluate the in vivo kinematics of TKA performed with two different prosthesis: a kinematic retaining (Physica KR) and a posterior-stabilized (Physica PS) design by means of fluoroscopic analysis during activities of daily living (rising from a chair, stairs climbing, leg extension). In comparison with asymptomatic knee. Patterns of femoral rollback will be analyzed to assess if they are motor-task dependent and correlated with clinical outcomes.
- Conditions
- Total Knee Replacement
- Being tested
- Physica KR, Physica PS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physica KRDevice
Kinematic retaining total knee implant
Physica PSDevice
Posterior stabilized total knee implant
| Study group | Role | What they receive |
|---|---|---|
| Physica KR | Other | Patients who have received a Physica KR total knee implant. Receives: Device: Physica KR |
| Physica PS | Other | Patients who have received a Physica PS total knee implant. Receives: Device: Physica PS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the roll-back mechanism measured with the tibio-femoral contact points at different degrees of flexion
Using a software to replicate the movement using Computer-aided design (CAD) models. The movement is studied and the distance made by the femur on the tibia is calculated giving the information of the roll back.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ReplacementStudies of the same condition, open and under way.
- More trials run by Limacorporate S.p.aThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Limacorporate S.p.a
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luca Marega, MD, Principal investigator, Ospedale San Camillo, Trento
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02706990
- Sponsor's protocol ID
- K-10
- Status last verified
- Sep 2016
- First submitted
- 7 Mar 2016
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Kinematic Analysis of Total Knee Replacement With a Kinematic Retaining or a Posterior Stabilized Design During Activities of Daily Living
- ClinicalTrials.gov ID
- NCT02706990
- Acronym / sponsor ID
- K-10
- Conditions
- Total Knee Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Limacorporate S.p.aIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 11 Mar 2016 (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 aim of this study is to evaluate the in vivo kinematics of TKA performed with two different prosthesis: a kinematic retaining (Physica KR) and a posterior-stabilized (Physica PS) design by means of fluoroscopic analysis during activities of daily living (rising from a chair, stairs climbing, leg extension). In comparison with asymptomatic knee. Patterns of femoral rollback will be analyzed to assess if they are motor-task dependent and correlated with clinical outcomes.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physica KR | Other | Device: Physica KRPatients who have received a Physica KR total knee implant. |
| Physica PS | Other | Device: Physica PSPatients who have received a Physica PS total knee implant. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients submitted to Total knee arthroplasty (TKA) with Physica KR or PS;
- Patients with an appropriate initial fixation and stability of the knee prosthesis;
- Patients achieving a minimum flexion of 100° or a Knee Society Score (KSS) ≥ 65 (fair/good postoperative outcome) at 6-month follow-up;
- Patients affected by primary or secondary Osteoarthritis (OA) before surgery;
- Patients who understand the requirements of the study and are willing and able to comply with activities required for fluoroscopic examination;
Key exclusion criteria (9 listed)
- Patients with misalignment or axial malrotation of the knee prosthesis;
- Patients not able to achieve a minimum flexion of 100° or with a KSS Knee Score ≤ 65 points at 6-month follow-up;
- Patients who had or have planned a surgery on their uninvolved knee within a year;
- Muscular insufficiency or absence of muscololigamentous supporting structures required for adequate soft tissue balance;
- Patients who have significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery and evaluation;
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 |
|---|---|---|
| Physica KRKinematic retaining total knee implant | Device | Physica KR |
| Physica PSPosterior stabilized total knee implant | Device | Physica PS |
Primary outcome
Assessment of the roll-back mechanism measured with the tibio-femoral contact points at different degrees of flexion
Time frame: 6 months
Using a software to replicate the movement using Computer-aided design (CAD) models. The movement is studied and the distance made by the femur on the tibia is calculated giving the information of the roll back.
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 7 Mar 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.
Luca Marega, MD principal investigator
Ospedale San Camillo, Trento
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physica KR and Physica PS in people with Total Knee Replacement, run by Limacorporate S.p.a 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 6 inclusion and 9 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 7 Mar 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 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?
Assessment of the roll-back mechanism measured with the tibio-femoral contact points at different degrees of flexion (time frame: 6 months). 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 7 Mar 2017.