800 Participants Needed

Total Knee Replacement for Osteoarthritis

Recruiting at 2 trial locations
LS
FP
FA
Overseen ByFederica Azzimonti
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Limacorporate S.p.a
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the long-term performance of different knee replacement systems for individuals with osteoarthritis, a condition causing joint pain and stiffness. It evaluates how well these knee implants perform over time, focusing on patient experiences and X-ray results. Participants may receive one of four knee systems, including the Physica Cruciate Retaining Knee System, each designed to meet various needs during total knee replacement surgery. Suitable candidates have osteoarthritis or similar joint issues and are considering a total knee replacement. As an unphased trial, this study offers patients the chance to contribute to valuable research that could enhance future knee replacement options.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Physica system is safe for total knee replacement?

Research shows that the Physica knee systems are safe and achieve high patient satisfaction. Studies on the Physica Kinematic Retaining Knee System report a 99.4% success rate, indicating that almost all implants functioned well without needing replacement. Patients experienced significant improvements in knee function and pain relief.

The Physica Cruciate Retaining Knee System and its version with an LMC Liner have demonstrated similar positive outcomes. Patients reported less pain and improved movement after receiving the implant.

Early studies on the Physica Posterior Stabilized Knee System indicate good performance, with many patients returning to activities they enjoyed before their knee issues. The research suggests these systems are well-tolerated, with no major safety concerns.

Overall, studies have positively received these treatments, and the evidence suggests they are safe options for those considering knee replacement surgery.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these Physica knee systems because they offer tailored solutions for total knee replacement in osteoarthritis patients. Unlike traditional knee implants, the Physica Cruciate Retaining (CR) System and its variant with LMC Liner are designed to preserve the knee's natural ligaments, potentially enhancing stability and function. The Physica Kinematic Retaining (KR) System aims to mimic the natural movement of the knee, providing a more natural feel for patients. Meanwhile, the Physica Posterior Stabilized (PS) System offers increased stability for those who need it. Each option provides a unique approach to addressing the specific needs of patients, potentially leading to better outcomes and greater satisfaction.

What evidence suggests that this trial's treatments could be effective for osteoarthritis?

Research shows that the different Physica knee systems studied in this trial hold promise for people with osteoarthritis. Participants may receive the Physica Cruciate Retaining Knee System, which studies reveal significantly improves knee function, leading to better patient outcomes. Another option is the Physica Kinematic Retaining Knee System, which also demonstrates impressive improvements and a 99.4% success rate, indicating that most implants last long without needing replacement. Participants may also receive the Physica Posterior Stabilized Knee System, for which results indicate good patient-reported outcomes and functional performance. Overall, these systems receive positive feedback for enhancing knee function and patient satisfaction.12467

Who Is on the Research Team?

FP

Fabiana Pavan

Principal Investigator

Limacorporate S.p.a

Are You a Good Fit for This Trial?

This trial is for adults over 22 with knee issues like osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or deformities needing a total knee replacement. Candidates must be able to follow the study's rehab program and attend all visits. Exclusions include poor bone quality, active infections, certain past surgeries or conditions affecting bone health, pregnancy, and severe instability of the knee.

Inclusion Criteria

I have arthritis or need surgery to correct a knee deformity.
My knee's side ligaments are healthy and working well.
I am a candidate for knee replacement and my knee's condition matches the specific requirements.
See 4 more

Exclusion Criteria

I have significant bone loss in my leg joints.
My leg circulation problems could affect the study's tests.
Any psychiatric illness that would prevent comprehension of the details and nature of the study
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Subjects are implanted with one of the configurations of the Physica system: Physica KR, Physica CR, or Physica PS

Surgery and immediate post-operative period

Follow-up

Participants are monitored for implant survivorship, clinical performance, and patient-reported outcomes

10 years

Ancillary Follow-up

Ancillary subgroup follow-up for clinical and radiographic assessments

5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Physica Cruciate Retaining Knee System
  • Physica Cruciate Retaining Knee System with LMC Liner
  • Physica Kinematic Retaining Knee System
  • Physica Posterior Stabilized Knee System
Trial Overview The Physica System Total Knee Replacement Registry Study aims to track long-term performance (up to 10 years) of different Physica knee implants in patients with various types of knee problems. It will collect data on implant survival rates as well as patient-reported outcomes and x-ray results.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: Physica PSExperimental Treatment1 Intervention
Group II: Physica KRExperimental Treatment1 Intervention
Group III: Physica CR with LMC LinerExperimental Treatment1 Intervention
Group IV: Physica CRExperimental Treatment1 Intervention

Physica Cruciate Retaining Knee System is already approved in European Union, United States, Canada for the following indications:

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Approved in European Union as Physica KR for:
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Approved in United States as Physica KR for:
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Approved in Canada as Physica KR for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Limacorporate S.p.a

Lead Sponsor

Trials
31
Recruited
3,300+

Published Research Related to This Trial

In a study of 44 patients (50 knees) who underwent JOURNEY II bi-cruciate stabilized total knee arthroplasty, a significant rotational mismatch (average of 3.2°) between the femoral and tibial components was found to negatively impact clinical outcomes, including patient satisfaction and functional activities.
The optimal cut-off for femorotibial rotational mismatch was determined to be 2.8°, indicating that maintaining proper alignment is crucial for achieving better results after surgery.
Rotational mismatch between femoral and tibial components should be avoided in JOURNEY II bi-cruciate stabilized total knee arthroplasty.Fujita, M., Matsumoto, T., Nakano, N., et al.[2022]
In a study of 113 knees undergoing bi-cruciate stabilized (BCS) total knee arthroplasty (TKA), key predictors of patient satisfaction included a high preoperative Knee injury and Osteoarthritis Outcome Score (KOOS) for daily activities, male sex, older age, and minimal medial joint laxity during flexion.
The findings suggest that maintaining proper stability of the medial compartment during the BCS TKA procedure is crucial for achieving high patient satisfaction post-surgery.
Preoperative and intraoperative factors contributing to patient satisfaction after bi-cruciate stabilized total knee arthroplasty.Inui, H., Taketomi, S., Yamagami, R., et al.[2022]
In a study of 104 knees undergoing bi-cruciate stabilized (BCS) total knee arthroplasty (TKA), key surgical factors such as medial joint laxity at 30° flexion and tibial alignment significantly influenced patient satisfaction, with a postoperative satisfaction score averaging 28.6 out of 40.
To enhance patient satisfaction after BCS TKA, surgeons should focus on maintaining stability in the medial compartment and avoid excessive external rotation and varus alignment of the tibia during the procedure.
Influence of surgical factors on patient satisfaction after bi-cruciate stabilized total knee arthroplasty: retrospective examination using multiple regression analysis.Inui, H., Taketomi, S., Yamagami, R., et al.[2021]

Citations

Physica System KR Vs Physica System CR (K-20)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 ...
Early outcomes using a 'kinematic retaining' total knee ...This prospective study examines the early clinical outcomes of 156 patients implanted with a novel 'kinematic-retaining' (KR) implant.
Mid-term outcomes of a kinematically designed cruciate ...Patients who received the kinematically-designed cruciate retaining TKA showed significant improvements in Knee Injury and Osteoarthritis Outcome Score for ...
Mid-term outcomes using a 'kinematic retaining' total knee ...This novel 'kinematic retaining' knee prosthesis has shown exceptional clinical and patient-reported improvements, with a remarkable 99.4% survivorship (95.5- ...
Short-term clinical outcomes of primary total knee ...In this study, we validated the effectiveness of the KR design and compared it with preexisting another cruciate retaining (CR) prosthesis, Persona CR® (Zimmer ...
Physica System Total Knee Replacement Registry StudyThe primary objective of this study is to obtain long-term implant survivorship (out to 10 years) and to assess clinical, patient-reported ...
Current Clinical TrialsThe 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 ...
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