Primary Total Knee ReplacementK-06NCT02118272
Clinical Study Evaluating the Outcomes of a New Knee System with a Physiological Rollback Mechanism
A study testing Physica KR in people with Primary Total Knee Replacement, run by Limacorporate S.p.a at 3 sites in 2 countries.
Trial summary
The aim of this study is to assess the clinical, radiographic and patient-reported outcome measures (PROMs) after total knee replacement with Physica KR, define the survivorship of the implants and identify possible risk factors that may lead to failure. Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Primary Total Knee Replacement
- What is being tested?
- Physica KR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 3 sitesin 2 countries
- Study dates
- May 2014to Nov 2021
- 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
- Male and females
- Age 22-80 years
- Any race
- Ambulatory patients
- Patients who have a medical condition with over 5 years of life expectancy
- Patients requiring knee prosthesis, suitable for the use of Physica KR
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- Patients with painful primary knee osteoarthritis
- Patients with painful secondary knee osteoarthritis
- Patients who are suffering from inflammatory arthritis (e.g. rheumatoid arthritis)
- Patients who have undamaged and functional collateral and posterior cruciate ligaments
- Patients with a flexion greater than or equal to 90° on the affected side
- Patients with a fixed flexion contracture less than 10°
- 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 approved study-specific Informed Consent Form prior to the surgery
Who cannot join
- Obese patients with BMI above 35 kg/m2 (severe obesity)
- Previous partial knee replacement (unilateral, bicompartimental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or femoral osteotomy in the affected knee
- Primary Total Knee Replacement (TKR) in the affected knee
- Varus or Valgus deformity greater than 20°
- Patients with a fixed flexion contracture greater than 10°
- Previous knee replacement on the contralateral side within the last year and whose outcome is achieving an KSS< 70 points
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- Patients with symptomatic OA of the hips, spine, ankles, if it can interfere with the evaluation of the target knee
- Patients with active or any suspected infection (on the affected knee or systemic)
- Muscular insufficiency or absence of muscoligamentous supporting structures required for adequate soft tissue balance
- Patients with known or suspicious metal hypersensitivity
- Recurrent medical history of severe allergic or immune-mediated reactions
- Vascular insufficiency of lower limbs severe enough to interfere with the study evaluation
- Current treatment or treatment within the previous 2 years before the screening visit for malignant and life-threatening non-malignant disorders
- Any clinically significant pathology based on clinical history that the Investigator feels may affect the study evaluation
- Any intercurrent chronic disease or condition that may interfere with the completion of the 5-year follow-up, such as liver disease, severe coronary disease, alcohol or drug abuse, disordered mental state, or other clinically significant condition
- 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
- Patients with systemic or metabolic disorders leading to progressive bone deterioration
- Patients who have a medical condition with less 5 years of life expectancy
- Previous organ transplant surgery
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United Kingdom2 sites
The Royal Bournemouth Hospital, NHS Foundation Trust
Bournemouth, Dorset, BH7 7DW
Dorset County Hospital NHS Foundation Trust
Dorchester, Dorset, DT1 2JY
About this study
Official title: A Multicentre, Prospective Clinical Study Evaluating the Outcomes of a New Knee System with a Physiological Rollback Mechanism
The aim of this study is to assess the clinical, radiographic and patient-reported outcome measures (PROMs) after total knee replacement with Physica KR, define the survivorship of the implants and identify possible risk factors that may lead to failure.
- Conditions
- Primary Total Knee Replacement
- Being tested
- Physica KR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physica KRDevice
| Study group | Role | What they receive |
|---|---|---|
| Physica KR | Other | Not described Receives: Device: Physica KR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Society Clinical Rating System (KSS)
Measured: From baseline to 5 year follow up
Secondary outcomes (6)
Knee injury and Osteoarthritis Outcome Score (KOOS)
Measured: From baseline to 5 year follow-up
Oxford Knee Score (OKS)
Measured: From baseline to 5 year follow-up
Satisfaction Visual Analogue Scale (VAS)
Measured: From baseline to 5 year follow-up
Survival rate of the implant
Measured: at 3 and 5 year follow-up
Incidence of AE/SAE, ADE/SADE
Measured: From baseline to 5 year follow-up
Forgotten Joint score (FJS)
Measured: From baseline to 5 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionNov 2021
- Study completionNov 2021
Why it stopped: Study concluded as per protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 156 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
- NCT02118272
- Sponsor's protocol ID
- K-06 Physica KR
- Acronym
- K-06
- Status last verified
- Mar 2025
- First submitted
- 11 Apr 2014
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- 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 Multicentre, Prospective Clinical Study Evaluating the Outcomes of a New Knee System with a Physiological Rollback Mechanism
- ClinicalTrials.gov ID
- NCT02118272
- Acronym / sponsor ID
- K-06 / K-06 Physica KR
- Conditions
- Primary Total Knee Replacement
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study concluded as per protocol
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Limacorporate S.p.aIndustry (pharma, biotech, devices)
- Study start
- May 2014 (actual)
- Primary completion
- Nov 2021 (actual)
- Study completion
- Nov 2021 (actual)
- First posted
- 21 Apr 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.
The aim of this study is to assess the clinical, radiographic and patient-reported outcome measures (PROMs) after total knee replacement with Physica KR, define the survivorship of the implants and identify possible risk factors that may lead to failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physica KR | Other | Device: Physica KR |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male and females
- Age 22-80 years
- Any race
- Ambulatory patients
- Patients who have a medical condition with over 5 years of life expectancy
Key exclusion criteria (23 listed)
- Obese patients with BMI above 35 kg/m2 (severe obesity)
- Previous partial knee replacement (unilateral, bicompartimental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or femoral osteotomy in the affected knee
- Primary Total Knee Replacement (TKR) in the affected knee
- Varus or Valgus deformity greater than 20°
- Patients with a fixed flexion contracture greater than 10°
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 KR | Device | Physica KR |
Primary outcome
Knee Society Clinical Rating System (KSS)
Time frame: From baseline to 5 year follow up
6 secondary outcomes
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: From baseline to 5 year follow-up
Oxford Knee Score (OKS)
Time frame: From baseline to 5 year follow-up
Satisfaction Visual Analogue Scale (VAS)
Time frame: From baseline to 5 year follow-up
Survival rate of the implant
Time frame: at 3 and 5 year follow-up
Incidence of AE/SAE, ADE/SADE
Time frame: From baseline to 5 year follow-up
Forgotten Joint score (FJS)
Time frame: From baseline to 5 year follow-up
Results and safety
The study was stopped early (reason given: Study concluded as per protocol). 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.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physica KR in people with Primary Total Knee Replacement, run by Limacorporate S.p.a at 3 sites in 2 countries.
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 14 inclusion and 23 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 3 sites in United Kingdom, 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 was stopped early (reason given: Study concluded as per protocol). 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?
Knee Society Clinical Rating System (KSS) (time frame: From baseline to 5 year follow up). 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.