Total Knee ReplacementNCT04594447
Physica System KR Vs Physica System CR (K-20)
A study testing Physica Kinematic Retaining knee replacement and Physica Cruciate Retaining knee replacement in people with Total Knee Replacement, run by Limacorporate S.p.a at 1 site in United Kingdom.
Trial summary
Post-market, monocentric, randomised, open-label, parallel group, prospective study conducted in patients who have to perform a total knee replacement (TKR) with Physica KR or Physica CR system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- Physica Kinematic Retaining knee replacement and Physica Cruciate Retaining knee replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Sep 2021to 1 Apr 2024
- 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
- Males and females of any race requiring a total knee replacement and suitable for the use of one of the two configurations of the Physica system.
- Age ≥ 18 years old,
- Patients who are suffering from non-inflammatory degenerative joint disease (NIDJD): including knee osteoarthritis, post-traumatic knee arthritis, avascular necrosis; or patient who are suffering from inflammatory joint disease including rheumatoid arthritis.
- Suitable candidates for TKR who have undamaged and functional collateral ligaments
- Suitable candidates for TKR with Physica KR and CR who have an undamaged and functional posterior cruciate ligament.
- Patients who understand the conditions of the study and are willing and able to comply with the prescribed rehabilitation and to perform all scheduled follow-up visits.
- Patients who have signed the Ethics Committee/IRB approved study-specific Informed Consent Form prior to the surgery.
Who cannot join
- Patients with severe instability of the knee joint secondary to the absence of collateral ligament integrity and/or function.
- Patients with active or any suspected infection (on the affected knee or systemic)
- Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy
- Patients with significant bone loss on femoral or tibial joint side
- Current treatment for malignant and/or life-threatening nonmalignant disorders
- Patients with known incompatibility or allergy to the product materials, and/or metal hypersensitivity to implant materials
Show all 18Show fewer
- Patient with open epiphyses (immature patient with active bone growth).
- Vascular insufficiency of lower limbs severe enough to interfere with the study evaluation
- Patients with bone stock compromised by disease, infection or prior implantation that cannot provide adequate support and/or fixation to the prosthesis
- Patients with systemic or metabolic disorders leading to progressive bone deterioration which may impair fixation and stability of the implant
- Any concomitant disease and dependence that might affect the performance of the implanted prosthesis
- Any clinically significant pathology based on clinical history that the Investigator feels may affect the study evaluation (e.g. primary osteoporosis with significant bone loss, haemophilic disease, septicaemia, persistent acute or chronic osteomyelitis)
- 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
- Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint
- Any psychiatric illness that would prevent comprehension of the details and nature of the study
- Patients currently participating in any other surgical intervention studies or pain management studies
- 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: A Post-market,monocentric,randomised,open-label,parallel Group,prospective Clinical Study Evaluating the Functional Outcome of the Kinematic Physica KR Total Knee Replacement System Vs the Standard Physica CR Total Knee Replacement System
Post-market, monocentric, randomised, open-label, parallel group, prospective study conducted in patients who have to perform a total knee replacement (TKR) with Physica KR or Physica CR system.
Read the detailed description
The aim of the study is to evaluate the clinical, radiographic and PROMs outcomes of Total Knee Arthroplasty (TKA) with 2 Lima TKR design: Physica KR and Physica CR (randomization 1:1) from preoperative to 1-year follow-up.
- Conditions
- Total Knee Replacement
- Being tested
- Physica Kinematic Retaining knee replacement, Physica Cruciate Retaining knee replacement
- Keywords
- Physica KR, Physica CR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physica Kinematic Retaining knee replacementDevice
modular knee prosthesis with a Kinematic Retaining (KR) mechanism and posterior cruciate ligament (PCL) preservation
Physica Cruciate Retaining knee replacementDevice
modular knee prosthesis with posterior cruciate ligament (PCL) preservation
| Study group | Role | What they receive |
|---|---|---|
| Physica KR | Other | Subject that receive Physica Kinematic Retaining total Knee replacement system Receives: Device: Physica Kinematic Retaining knee replacement |
| Physica CR | Other | Subject that receive Physica Cruciate Retaining total Knee replacement system Receives: Device: Physica Cruciate Retaining knee replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford Knee Score (OKS)
Changes of the Oxford Knee Score (OKS) from preoperative (baseline) to 1 year after the implant of the Physica KR compared to Physica CR designs.
Specifically designed and developed to assess function and pain after TKR surgery. Responses to each question ranges from 0-4 with a range of a possible overall score from 0-48. A score of 0 is the worst possible outcome while a score of 48 is the best possible outcome.
Measured: Baseline to 1 year FU
Secondary outcomes (10)
30-second Chair Stand Test (30 CST)
Functional changes in 30-second Chair Stand Test (30 CST) from pre-operative (baseline) to 1 year after the implant of the Physica KR compared to Physica CR designs.
Measured: Baseline to 1 year FU
40 metre fast paced walk test
Functional changes in 40 metre fast paced walk test from preoperative (baseline) to 1 year after the implant of the Physica KR compared to Physica CR designs.
Measured: Baseline to 1 year FU
Knee injury and Osteoarthritis Outcome Score (KOOS)
Changes in the Knee injury and Osteoarthritis Outcome Score (KOOS) from pre-operative (baseline) to 1 year after the implant of the Physica KR compared to Physica CR designs.
KOOS is a 42-item self-administered self-explanatory questionnaire that covers five patient-relevant dimensions: Pain, Other Disease-Specific Symptoms, Active Daily Living Function, Sport and Recreation Function, and knee-related Quality of Life. A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems
Measured: Baseline to 1 year FU
Medical Outcomes Survey Short Form-36 (SF-36) RAND SF-36
Changes in 36-Item Short Form Health Survey (SF-36) outcome from pre-operative (baseline) to 1 year after the implant.
This questionnaire includes 8 scales of differing domains of health: physical functioning, bodily pain, role-physical, general health, vitality, role emotional, social functioning, and mental health. Each scale is scored on a 0 to 100 scale with a 100 representing the best score possible.
Measured: Baseline to 1 year FU
Forgotten Joint Score (FJS)
Changes in the Forgotten Joint Score (FJS) from pre-operative (baseline) to 1 year after the implant of the Physica KR compared to Physica CR designs.
It comprises measures for the assessment of joint-specific patient-reported outcome and focus on patients' awareness of a specific joint in everyday life. It consists of 12 questions and is scored using a 5-point Likert response format (never-almost never-seldom- sometimes-mostly) with the raw scores transformed onto a 0-100 point scale. High scores indicate good outcome.
Measured: Baseline to 1 year FU
Range of Motion (ROM)
Changes in the Range of Motion (ROM) from pre-operative (baseline) to 1 year after the implant of the Physica KR compared to Physica CR designs.
Measured: Baseline to 1 year FU
Knee Society Score (KSS)
Changes in the Knee Society Score (KSS) from pre-operative (baseline) to 1 year after the implant of the Physica KR compared to Physica CR designs.
KSS is divided into two components to assess the knee clinically through the physical examination, and to assess the individual's functionality . The maximum score of 100 points that is the best outcome.
Measured: Baseline to 1 year FU
Radiographic evaluation
Radiographic implant evaluation and stability assessment of the Physica KR compared to Physica CR designs at baseline and 1 year after the implant.
Measured: Baseline to 1 year FU
Serious Adverse Event (SAE) incidence
Changes Incidence, type and severity of all device-related Serious Adverse Events (SAEs) at intra-operatively, at discharge, 6 months and 1 year after the implant.
Measured: Baseline to 1 year FU
Adverse Event (AE) device related incidence
Incidence, type and severity of all device-related Adverse Events (AEs) at intraoperatively, at discharge, 6 months and 1 year after the implant
Measured: Baseline to 1 year FU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start30 Sep 2021
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Why it stopped: Problems with enrollement
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Limacorporate S.p.a
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04594447
- Sponsor's protocol ID
- K-20
- Status last verified
- Mar 2025
- First submitted
- 14 Oct 2020
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-market,monocentric,randomised,open-label,parallel Group,prospective Clinical Study Evaluating the Functional Outcome of the Kinematic Physica KR Total Knee Replacement System Vs the Standard Physica CR Total Knee Replacement System
- ClinicalTrials.gov ID
- NCT04594447
- Acronym / sponsor ID
- K-20
- Conditions
- Total Knee Replacement
- Keywords
- Physica KR, Physica CR
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Problems with enrollement
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Limacorporate S.p.aIndustry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 20 Oct 2020 (actual)
- 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.
Post-market, monocentric, randomised, open-label, parallel group, prospective study conducted in patients who have to perform a total knee replacement (TKR) with Physica KR or Physica CR system.
Detailed description
The aim of the study is to evaluate the clinical, radiographic and PROMs outcomes of Total Knee Arthroplasty (TKA) with 2 Lima TKR design: Physica KR and Physica CR (randomization 1:1) from preoperative to 1-year follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physica KR | Other | Device: Physica Kinematic Retaining knee replacementSubject that receive Physica Kinematic Retaining total Knee replacement system |
| Physica CR | Other | Device: Physica Cruciate Retaining knee replacementSubject that receive Physica Cruciate Retaining total Knee replacement system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females of any race requiring a total knee replacement and suitable for the use of one of the two configurations of the Physica system.
- Age ≥ 18 years old,
- Patients who are suffering from non-inflammatory degenerative joint disease (NIDJD): including knee osteoarthritis, post-traumatic knee arthritis, avascular necrosis; or patient who are suffering from inflammatory joint disease including rheumatoid arthritis.
- Suitable candidates for TKR who have undamaged and functional collateral ligaments
- Suitable candidates for TKR with Physica KR and CR who have an undamaged and functional posterior cruciate ligament.
Key exclusion criteria (18 listed)
- Patients with severe instability of the knee joint secondary to the absence of collateral ligament integrity and/or function.
- Patients with active or any suspected infection (on the affected knee or systemic)
- Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy
- Patients with significant bone loss on femoral or tibial joint side
- Current treatment for malignant and/or life-threatening nonmalignant disorders
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 Kinematic Retaining knee replacementmodular knee prosthesis with a Kinematic Retaining (KR) mechanism and posterior cruciate ligament (PCL) preservation | Device | Physica KR |
| Physica Cruciate Retaining knee replacementmodular knee prosthesis with posterior cruciate ligament (PCL) preservation | Device | Physica CR |
Primary outcome
Oxford Knee Score (OKS)
Time frame: Baseline to 1 year FU
Changes of the Oxford Knee Score (OKS) from preoperative (baseline) to 1 year after the implant of the Physica KR compared to Physica CR designs. Specifically designed and developed to assess function and pain after TKR surgery. Responses to each question ranges from 0-4 with a range of a possible overall score from 0-48. A score of 0 is the worst possible outcome while a score of 48 is the best possible outcome.
10 secondary outcomes
30-second Chair Stand Test (30 CST)
Time frame: Baseline to 1 year FU
40 metre fast paced walk test
Time frame: Baseline to 1 year FU
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline to 1 year FU
Medical Outcomes Survey Short Form-36 (SF-36) RAND SF-36
Time frame: Baseline to 1 year FU
Forgotten Joint Score (FJS)
Time frame: Baseline to 1 year FU
Range of Motion (ROM)
Time frame: Baseline to 1 year FU
Knee Society Score (KSS)
Time frame: Baseline to 1 year FU
Radiographic evaluation
Time frame: Baseline to 1 year FU
Serious Adverse Event (SAE) incidence
Time frame: Baseline to 1 year FU
Adverse Event (AE) device related incidence
Time frame: Baseline to 1 year FU
Results and safety
The study was stopped early (reason given: Problems with enrollement). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: No
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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 Physica Kinematic Retaining knee replacement and Physica Cruciate Retaining knee replacement 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 18 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: stopped early, as of the sponsor's last update on 10 Mar 2025. 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 was stopped early (reason given: Problems with enrollement). Results are not available in the source record.
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?
Oxford Knee Score (OKS) (time frame: Baseline to 1 year FU). 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 10 Mar 2025; AzTrials last refreshed its copy on 29 Oct 2026.