Osteoarthritis, KneeNCT03048201
Physica System Total Knee Replacement Registry Study
A study testing Physica Kinematic Retaining Knee System, Physica Cruciate Retaining Knee System and Physica Posterior Stabilized Knee System in people with Osteoarthritis, Knee and Traumatic Arthritis, run by Limacorporate S.p.a at 5 sites in United States.
Trial summary
The primary objective of this study is to obtain long-term implant survivorship (out to 10 years) and to assess clinical, patient-reported outcome measures, and radiographic data for the commercially available Physica system. For ancillary arm, from baseline to 5-year follow-up. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Traumatic Arthritis, Avascular Necrosis
- What is being tested?
- Physica Kinematic Retaining Knee System, Physica Cruciate Retaining Knee System and Physica Posterior Stabilized Knee System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 5 sitesUnited States
- Study dates
- 24 Mar 2017to Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 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 configurations of the Physica system
- Age> 22 (skeletally mature)
- Patients who are suffering from non-inflammatory degenerative joint disease (NIDJD):
- including knee osteoarthritis, post-traumatic knee arthritis; or patients who are suffering from inflammatory arthritis; or patients that need correction of a functional deformity
- Suitable candidates for TKR who have undamaged and functional collateral ligaments
- Suitable candidates for TKR with Physica KR, CR, who have an undamaged and functional posterior cruciate ligament; or Physica LMC with or without a functioning posterior cruciate ligament or Physica PS with an absent or not-functioning posterior cruciate ligament and/or severe antero-posterior instability of the knee joint
- 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 (unicompartimental, bicompartimental 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 non-malignant disorders
- Patients with known incompatibility or allergy to the product materials, and/or metal hypersensitivity to implant materials
Show all 17Show fewer
- 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
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Federica Azzimonti contact
5 sites in 1 country
United States5 sites, 3 recruiting
- Recruiting
Rush Castle Orthopaedics
Aurora, Illinois, 60504
Mark Schinsky, MD, 630-978-3800
Renee Bergstrom, +1-630-978-3800
- Recruiting
The Orthopedics Clinic
Daytona Beach, Florida, 32117
Mark Gillespy, MD, 386-255-4596
Sherri Zicker, +1-386-255-4596
- Completed
Joint Reconstructive Specialist
Oklahoma City, Oklahoma, 73159
- Recruiting
Eisenhower Desert Orthopedics Center - Harry and Diane Rinker Bldg
Rancho Mirage, California, 92270
Izzy Nunez, 760-766-2540, inunez@eisenhowerhealth.org
Wendy Monaco, 7607662540, wmonaco@eisenhowerhealth.org
- Completed
Syracuse Orthopedic Specialists
Syracuse, New York, 13214
About this study
Official title: Post-market Registry Study on the Physica System Total Knee Replacement
The primary objective of this study is to obtain long-term implant survivorship (out to 10 years) and to assess clinical, patient-reported outcome measures, and radiographic data for the commercially available Physica system. For ancillary arm, from baseline to 5-year follow-up.
Read the detailed description
This is a post-market registry study; the study device is FDA cleared and used according to the intended use.
This is a multi-centre, prospective, non-randomized study.
Subjects will be implanted with one of the following configurations of the Physica system: Physica KR (Kinematic Retaining), Physica CR (Cruciate Retaining) or Physica PS (Posterior Stabilized). The assignment of any patient involved in the study is determined by the aetiology preoperatively evaluated by the Investigator and falls within current practice. The decision to use a specific prosthesis design is decided by the Investigators independently and clearly separated from the decision to include the patient in the study.
For the ancillary subgroup, investigators currently contributing to the primary patient group can also enroll additional patients to the ancillary subgroup. 3 existing sites and 2 additional sites are planned to be added to contribute to the additional 300 patients to be enrolled. These patients will follow the same study schedules as the main study, but follow-up is only up to 5 years.
Baseline measurements (pre-operative clinical analysis and radiographic analysis at 6-week FU) will serve as internal control term during the assessment of post-surgery data out to 10 years.
- Conditions
- Osteoarthritis, Knee, Traumatic Arthritis, Avascular Necrosis, Degenerative Joint Disease of Knee, Rheumatoid Arthritis, Deformity of Knee
- Being tested
- Physica Kinematic Retaining Knee System, Physica Cruciate Retaining Knee System, Physica Posterior Stabilized Knee System, Physica Cruciate Retaining Knee System with LMC Liner
- Keywords
- Physica KR, Physica CR, Physica PS, Kinematic Retaining, Cruciate Retaining, Posterior Stabilized, Physica System
- Medical subject headings
- Osteoarthritis, Knee, Osteonecrosis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physica Kinematic Retaining Knee SystemDevice
Modular total knee prosthesis with a Kinematic Retaining mechanism and posterior cruciate ligament (PCL) preservation
Physica Cruciate Retaining Knee SystemDevice
Total knee prosthesis with posterior cruciate ligament (PCL) preservation
Physica Posterior Stabilized Knee SystemDevice
Total knee prosthesis that sacrifices the posterior cruciate ligament (PCL) and replaces the functionality of the PCL with a post-cam mechanism.
Physica Cruciate Retaining Knee System with LMC LinerDevice
Total knee prosthesis with posterior cruciate ligament (PCL) preservation
| Study group | Role | What they receive |
|---|---|---|
| Physica KR | Other | Subjects that receive the Physica Kinematic Retaining Knee System Receives: Device: Physica Kinematic Retaining Knee System |
| Physica CR | Other | Subjects that receive the Physica Cruciate Retaining Knee System Receives: Device: Physica Cruciate Retaining Knee System |
| Physica PS | Other | Subjects that receive the Physica Posterior Stabilized Knee System Receives: Device: Physica Posterior Stabilized Knee System |
| Physica CR with LMC Liner | Other | Subjects that receive the Physica Cruciate Retaining Knee System with LMC Liner Receives: Device: Physica Cruciate Retaining Knee System with LMC Liner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Survivorship
The primary endpoint is the definition of the implant survivorship of the study device to 10 years after the total knee replacement surgery.
Measured: 10 years
Secondary outcomes (3)
American Knee Society Score (KSS) 2011
Clinical performance assessment measured by overall pain and functionality from baseline to 10-year follow-up
Measured: 10 years
Patient-Reported Outcome Measures (PROMs)
Patient-Reported Outcome Measures (PROMs) including patient satisfaction achievement from baseline to 10-year follow-up
Measured: 10 years
Radiographic Evaluation
- Radiographic implant evaluation and stability assessment from baseline to 10-year follow-up
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start24 Mar 2017
- Primary completionMar 2030 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Non-randomised
- Intervention model
- Single group
- Model description
- Subjects will receive a commercially available Physica system total knee replacement in one of 3 different configurations: KR (Kinematic Retaining), CR (Cruciate Retaining) and PS (Posterior Stabilized). The assignment of any patient involved in the study is determined by the aetiology preoperatively evaluated by the Investigator and falls within current practice.
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Limacorporate S.p.a
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fabiana Pavan, Study director, Limacorporate S.p.a
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03048201
- Sponsor's protocol ID
- K-11
- Status last verified
- Mar 2023
- First submitted
- 7 Feb 2017
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Registry Study on the Physica System Total Knee Replacement
- ClinicalTrials.gov ID
- NCT03048201
- Acronym / sponsor ID
- K-11
- Conditions
- Osteoarthritis, Knee, Traumatic Arthritis, Avascular Necrosis, Degenerative Joint Disease of Knee, Rheumatoid Arthritis, Deformity of Knee
- Keywords
- Physica KR, Physica CR, Physica PS, Kinematic Retaining, Cruciate Retaining, Posterior Stabilized, Physica System
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Limacorporate S.p.aIndustry (pharma, biotech, devices)
- Study start
- 24 Mar 2017 (actual)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 9 Feb 2017 (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 primary objective of this study is to obtain long-term implant survivorship (out to 10 years) and to assess clinical, patient-reported outcome measures, and radiographic data for the commercially available Physica system. For ancillary arm, from baseline to 5-year follow-up.
Detailed description
This is a post-market registry study; the study device is FDA cleared and used according to the intended use.
This is a multi-centre, prospective, non-randomized study.
Subjects will be implanted with one of the following configurations of the Physica system: Physica KR (Kinematic Retaining), Physica CR (Cruciate Retaining) or Physica PS (Posterior Stabilized). The assignment of any patient involved in the study is determined by the aetiology preoperatively evaluated by the Investigator and falls within current practice. The decision to use a specific prosthesis design is decided by the Investigators independently and clearly separated from the decision to include the patient in the study.
For the ancillary subgroup, investigators currently contributing to the primary patient group can also enroll additional patients to the ancillary subgroup. 3 existing sites and 2 additional sites are planned to be added to contribute to the additional 300 patients to be enrolled. These patients will follow the same study schedules as the main study, but follow-up is only up to 5 years.
Baseline measurements (pre-operative clinical analysis and radiographic analysis at 6-week FU) will serve as internal control term during the assessment of post-surgery data out to 10 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Subjects will receive a commercially available Physica system total knee replacement in one of 3 different configurations: KR (Kinematic Retaining), CR (Cruciate Retaining) and PS (Posterior Stabilized). The assignment of any patient involved in the study is determined by the aetiology preoperatively evaluated by the Investigator and falls within current practice.
| Arm | Type | Receives |
|---|---|---|
| Physica KR | Other | Device: Physica Kinematic Retaining Knee SystemSubjects that receive the Physica Kinematic Retaining Knee System |
| Physica CR | Other | Device: Physica Cruciate Retaining Knee SystemSubjects that receive the Physica Cruciate Retaining Knee System |
| Physica PS | Other | Device: Physica Posterior Stabilized Knee SystemSubjects that receive the Physica Posterior Stabilized Knee System |
| Physica CR with LMC Liner | Other | Device: Physica Cruciate Retaining Knee System with LMC LinerSubjects that receive the Physica Cruciate Retaining Knee System with LMC Liner |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males and females of any race requiring a total knee replacement and suitable for the use of one of the configurations of the Physica system
- Age> 22 (skeletally mature)
- Patients who are suffering from non-inflammatory degenerative joint disease (NIDJD):
- including knee osteoarthritis, post-traumatic knee arthritis; or patients who are suffering from inflammatory arthritis; or patients that need correction of a functional deformity
- Suitable candidates for TKR who have undamaged and functional collateral ligaments
Key exclusion criteria (17 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 (unicompartimental, bicompartimental 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 non-malignant 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 SystemModular total knee prosthesis with a Kinematic Retaining mechanism and posterior cruciate ligament (PCL) preservation | Device | Physica KR |
| Physica Cruciate Retaining Knee SystemTotal knee prosthesis with posterior cruciate ligament (PCL) preservation | Device | Physica CR |
| Physica Posterior Stabilized Knee SystemTotal knee prosthesis that sacrifices the posterior cruciate ligament (PCL) and replaces the functionality of the PCL with a post-cam mechanism. | Device | Physica PS |
| Physica Cruciate Retaining Knee System with LMC LinerTotal knee prosthesis with posterior cruciate ligament (PCL) preservation | Device | Physica CR with LMC Liner |
Primary outcome
Implant Survivorship
Time frame: 10 years
The primary endpoint is the definition of the implant survivorship of the study device to 10 years after the total knee replacement surgery.
3 secondary outcomes
American Knee Society Score (KSS) 2011
Time frame: 10 years
Patient-Reported Outcome Measures (PROMs)
Time frame: 10 years
Radiographic Evaluation
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- 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.
Federica Azzimonti contact
Fabiana Pavan study director
Limacorporate S.p.a
5 sites 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 System, Physica Cruciate Retaining Knee System and Physica Posterior Stabilized Knee System in people with Osteoarthritis, Knee and Traumatic Arthritis, run by Limacorporate S.p.a at 5 sites in United States.
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 8 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabiana Pavan (+390432945357, Fabiana.Pavan@limacorporate.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant Survivorship (time frame: 10 years). 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 21 Mar 2023.