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RecruitingNCT03048201Updated Mar 21, 2023

Physica System Total Knee Replacement Registry Study

An interventional study of Physica Kinematic Retaining Knee System and Physica Cruciate Retaining Knee System in Osteoarthritis, Knee, Traumatic Arthritis and Avascular Necrosis, sponsored by Limacorporate S.p.a. Recruiting at 5 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2023-03-21.

Sponsored by Limacorporate S.p.a (part of Enovis) · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2017; still recruiting 9 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
800
Allocation
Non-randomized
Ages
22 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • 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
03

In context

Osteoarthritis, Knee

3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.

This study's planned enrollment of 800 is above the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Limacorporate S.p.a is the lead sponsor of 31 studies on the registry; 12 are open to participants now.

First submitted before Limacorporate S.p.a became part of Enovis.

Browse Limacorporate S.p.a studies →All Enovis studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 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
  2. Age> 22 (skeletally mature)

  3. 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

  4. Suitable candidates for TKR who have undamaged and functional collateral ligaments
  5. 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
  6. 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
  7. Patients who have signed the Ethics Committee/IRB approved study-specific Form prior to the surgery

Exclusion criteria

Exclusion Criteria:

  1. Patients with severe instability of the knee joint secondary to the absence of collateral ligament integrity and/or function
  2. Patients with active or any suspected infection (on the affected knee or systemic)
  3. Previous partial knee replacement (unicompartimental, bicompartimental or patellofemoral joint replacement), patellectomy, high tibial osteotomy
  4. Patients with significant bone loss on femoral or tibial joint side
  5. Current treatment for malignant and/or life-threatening non-malignant disorders
  6. Patients with known incompatibility or allergy to the product materials, and/or metal to implant materials
  7. Vascular insufficiency of lower limbs severe enough to interfere with the study evaluation
  8. Patients with bone stock compromised by disease, infection or prior implantation that cannot provide adequate support and/or fixation to the prosthesis
  9. Patients with systemic or metabolic disorders leading to progressive bone deterioration which may impair fixation and stability of the implant
  10. Any concomitant disease and dependence that might affect the performance of the implanted prosthesis
  11. Any 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)
  12. Patients who have significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery and evaluation
  13. Patients who have neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device
  14. Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint
  15. Any psychiatric illness that would prevent comprehension of the details and nature of the study
  16. Patients currently participating in any other surgical intervention studies or pain management studies
  17. Female patients who are pregnant, nursing, or planning a pregnancy
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
800 participants (estimated)

Study arms

  • Other
    Physica KR

    Subjects that receive the Physica Kinematic Retaining Knee System

    Device: Physica Kinematic Retaining Knee System

  • Other
    Physica CR

    Subjects that receive the Physica Cruciate Retaining Knee System

    Device: Physica Cruciate Retaining Knee System

  • Other
    Physica PS

    Subjects that receive the Physica Posterior Stabilized Knee System

    Device: Physica Posterior Stabilized Knee System

  • Other
    Physica CR with LMC Liner

    Subjects that receive the Physica Cruciate Retaining Knee System with LMC Liner

    Device: Physica Cruciate Retaining Knee System with LMC Liner

Interventions

  • DevicePhysica Kinematic Retaining Knee System

    Modular total knee prosthesis with a Kinematic Retaining mechanism and posterior cruciate ligament (PCL) preservation

  • DevicePhysica Cruciate Retaining Knee System

    Total knee prosthesis with posterior cruciate ligament (PCL) preservation

  • DevicePhysica Posterior Stabilized Knee System

    Total knee prosthesis that sacrifices the posterior cruciate ligament (PCL) and replaces the functionality of the PCL with a post-cam mechanism.

  • DevicePhysica Cruciate Retaining Knee System with LMC Liner

    Total knee prosthesis with posterior cruciate ligament (PCL) preservation

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 10 years

Secondary outcomes

  1. American Knee Society Score (KSS) 2011

    Clinical performance assessment measured by overall pain and functionality from baseline to 10-year follow-up

    Time frame: 10 years

  2. Patient-Reported Outcome Measures (PROMs)

    Patient-Reported Outcome Measures (PROMs) including patient satisfaction achievement from baseline to 10-year follow-up

    Time frame: 10 years

  3. Radiographic Evaluation

    • Radiographic implant evaluation and stability assessment from baseline to 10-year follow-up

    Time frame: 10 years

07

Study locations

3 of 5 sites recruiting
  • Eisenhower Desert Orthopedics Center - Harry and Diane Rinker Bldg
    Rancho Mirage, California 92270, United States
    Recruiting
  • The Orthopedics Clinic
    Daytona Beach, Florida 32117, United States
    Recruiting
    • Mark Gillespy, MD · Contact386-255-4596
    • Sherri Zicker · Contact+1-386-255-4596
    • Mark Gillespy, MD · Principal investigator
  • Rush Castle Orthopaedics
    Aurora, Illinois 60504, United States
    Recruiting
    • Mark Schinsky, MD · Contact630-978-3800
    • Renee Bergstrom · Contact+1-630-978-3800
    • Mark Schinsky, MD · Principal investigator
  • Syracuse Orthopedic Specialists
    Syracuse, New York 13214, United States
    Completed

    Not enrolling at this site.

  • Joint Reconstructive Specialist
    Oklahoma City, Oklahoma 73159, United States
    Completed

    Not enrolling at this site.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2017 (actual). Primary completion is estimated for Mar 2030, 156 months after the start.

Of 140 industry-sponsored interventional studies with no phase under Osteoarthritis, Knee, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 34. This study's planned 156 months is above that.

Counting every sponsor, half of 1,251 studies reached it within 18 months; a quarter within 8 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 7, 2017
First posted
Feb 9, 2017
StartActual
Mar 24, 2017
Primary completionEst.
Mar 2030
CompletionEst.
Mar 2030
Last update
Mar 21, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03048201
Lead sponsor
Limacorporate S.p.a
Responsible party
Sponsor
First posted
Feb 9, 2017
Start date
Mar 24, 2017
Primary completion
Mar 2030 (estimated)
Completion
Mar 2030 (estimated)
Last update
Mar 21, 2023

Study contacts

Fabiana Pavan
Contact
Fabiana.Pavan@limacorporate.com
+390432945357
Federica Azzimonti
Contact
federica.azzimonti@limacorporate.com
Fabiana Pavan
study director · Limacorporate S.p.a

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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