Total Knee ReplacementNCT02655809
Physica KR Fluoroscopy Study
A study testing Fluoroscopic examination in people with Total Knee Replacement, run by Limacorporate S.p.a at 1 site in United Kingdom.
Trial summary
The aim of this study is to assess the in vivo kinematics and range of motion of a single-surgeon clinical series of TKA performed with a fixed-bearing cruciate retaining total knee arthroplasty that has a roll-back mechanism and compare it with the kinematic of the normal healthy knee. Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- Fluoroscopic examination
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2015to Nov 2018
- 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 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patientsoperated in The Royal Bournemouth Hospital NHS Foundation Trust and who has received a Physica KR implant
- Patients achieving a ROM ≥ 100° at 6 week follow-up in the Physica KR clinical trial (K-06 Study protocol 30/10/2013 v 1.0);
- Patients affected by primary or secondary OA before surgery;
- Patients with an appropriate intial fixation and stability of the knee prosthesis;
- Patients with undamaged and functional collateral and posterior cruciate ligaments (no ligamentous imbalance or pain);
- 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 a ROM < 100° at 6-week follow-up in Physica KR clinical trial (K-06- Study protocol 30/10/2013 v 1.0);
- Patients affected by rheumatoid arthritis;
- Patients with malalignment or axial malrotation of the knee prosthesis;
- Patients who had or have planned a surgery on their uninvolved knee within a year;
- Muscular insufficiency or absence of muscoligamentous 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;
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- Patients who have neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device;
- 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 preoperative visit, excluding the Physica KR clinical trial (K-06 Study protocol 30/10/2013 v 1.0);
- Female patients who are pregnant, nursing, or planning a pregnancy.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Bournemouth Hospital
Bournemouth, Dorset, BH7 7DW
About this study
Official title: Physica KR: In Vivo Kinematic Analysis of a Novel Total Knee Replacement Implant
The aim of this study is to assess the in vivo kinematics and range of motion of a single-surgeon clinical series of TKA performed with a fixed-bearing cruciate retaining total knee arthroplasty that has a roll-back mechanism and compare it with the kinematic of the normal healthy knee.
Patients would be evaluated by fluoroscopic examination during weight bearing activities (lounging, kneeling and stairs climbing).
- Conditions
- Total Knee Replacement
- Being tested
- Fluoroscopic examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoroscopic examinationRadiation
| Study group | Role | What they receive |
|---|---|---|
| Physica KR | Other | Patients who have received a Physica KR total knee implant. Receives: Radiation: Fluoroscopic examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the roll-back mechanism by measuring the contact point between tibia and femur components in millimeters
Using a software to replicate the movement using 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 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study startJun 2015
- Primary completionNov 2018
- Study completionNov 2018
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Limacorporate S.p.a
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02655809
- Sponsor's protocol ID
- K-07
- Status last verified
- Sep 2020
- First submitted
- 8 Jan 2016
- Last updated
- 19 Oct 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physica KR: In Vivo Kinematic Analysis of a Novel Total Knee Replacement Implant
- ClinicalTrials.gov ID
- NCT02655809
- Acronym / sponsor ID
- K-07
- Conditions
- Total Knee Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Limacorporate S.p.aIndustry (pharma, biotech, devices)
- Study start
- Jun 2015 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 14 Jan 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 assess the in vivo kinematics and range of motion of a single-surgeon clinical series of TKA performed with a fixed-bearing cruciate retaining total knee arthroplasty that has a roll-back mechanism and compare it with the kinematic of the normal healthy knee.
Patients would be evaluated by fluoroscopic examination during weight bearing activities (lounging, kneeling and stairs climbing).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physica KR | Other | Radiation: Fluoroscopic examinationPatients who have received a Physica KR total knee implant. |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patientsoperated in The Royal Bournemouth Hospital NHS Foundation Trust and who has received a Physica KR implant
- Patients achieving a ROM ≥ 100° at 6 week follow-up in the Physica KR clinical trial (K-06 Study protocol 30/10/2013 v 1.0);
- Patients affected by primary or secondary OA before surgery;
- Patients with an appropriate intial fixation and stability of the knee prosthesis;
- Patients with undamaged and functional collateral and posterior cruciate ligaments (no ligamentous imbalance or pain);
Key exclusion criteria (10 listed)
- Patients with a ROM < 100° at 6-week follow-up in Physica KR clinical trial (K-06- Study protocol 30/10/2013 v 1.0);
- Patients affected by rheumatoid arthritis;
- Patients with malalignment or axial malrotation of the knee prosthesis;
- Patients who had or have planned a surgery on their uninvolved knee within a year;
- Muscular insufficiency or absence of muscoligamentous supporting structures required for adequate soft tissue balance;
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 |
|---|---|---|
| Fluoroscopic examination | Radiation | Physica KR |
Primary outcome
Assessment of the roll-back mechanism by measuring the contact point between tibia and femur components in millimeters
Time frame: 6 months after surgery
Using a software to replicate the movement using 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 19 Oct 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluoroscopic examination in people with Total Knee Replacement, run by Limacorporate S.p.a at 1 site in United Kingdom.
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 7 inclusion and 10 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 19 Oct 2020. 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 United Kingdom. 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 by measuring the contact point between tibia and femur components in millimeters (time frame: 6 months after surgery). 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 19 Oct 2020.