Total Knee Replacement for Osteoarthritis

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Limacorporate S.p.a

Disqualifiers: Infections, Bone loss, Neurological disorders, others

Stay on Your Current Meds

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Physica Cruciate Retaining Knee System for total knee replacement?

Research suggests that the Physica KR implant, which retains the natural knee ligaments, may lead to better short-term functional outcomes and a more natural knee movement compared to conventional designs. This could result in improved range of motion and a more 'forgotten joint' feeling, meaning patients are less aware of their artificial joint. ^{1 2 3 4 5}

Is the Physica KR knee replacement system safe for humans?

The Physica KR knee replacement system has been studied for its functional outcomes and stability, showing good results in terms of knee movement and stability even when certain ligaments are not preserved. No specific safety concerns were reported in the studies reviewed. ^{1 6 7 8 9}

How does the Physica Knee System treatment for osteoarthritis differ from other treatments?

The Physica Knee System treatment for osteoarthritis is unique because it offers different designs like the Kinematic Retaining (KR) and Posterior Stabilized (PS) systems, which aim to improve knee function by either retaining or substituting the posterior cruciate ligament (PCL). This approach can lead to better functional outcomes and a more natural knee movement compared to conventional knee replacements. ^{1 4 5 10 11}

Research Team

Fabiana Pavan

Principal Investigator

Limacorporate S.p.a

Eligibility Criteria

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.

Exclusion Criteria

I have significant bone loss in my leg joints.

My leg circulation problems could affect the study's tests.

My bones are too weak to support a new implant due to disease, infection, or previous implants.

Trial Timeline

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

Treatment Details

Interventions

• Physica Cruciate Retaining Knee System (Prosthetic Device)
• Physica Cruciate Retaining Knee System with LMC Liner (Prosthetic Device)
• Physica Kinematic Retaining Knee System (Prosthetic Device)
• Physica Posterior Stabilized Knee System (Prosthetic Device)

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.

Participant Groups

Group I: Physica PS Experimental Treatment 1 Intervention

Subjects that receive the Physica Posterior Stabilized Knee System

Group II: Physica KR Experimental Treatment 1 Intervention

Subjects that receive the Physica Kinematic Retaining Knee System

Group III: Physica CR with LMC Liner Experimental Treatment 1 Intervention

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

Group IV: Physica CR Experimental Treatment 1 Intervention

Subjects that receive the Physica Cruciate Retaining Knee System

Physica Cruciate Retaining Knee System is already approved in Canada for the following indications:

Approved in Canada as Physica KR for:

• Primary osteoarthritis
• Post-traumatic arthritis
• Rheumatoid arthritis

Who Is Running the Clinical Trial?

Limacorporate S.p.a

Lead Sponsor

Trials

31

Recruited

3,300+

Findings from Research

In a study of 234 patients who underwent total knee arthroplasty, the Kinematics-Retaining (KR) implant showed significantly better functional outcomes at 36 months compared to the conventional Multigen Plus CR implant, particularly in active range of motion and Knee Society Scores (KSS).

While the KR implant demonstrated superior results in KSS scores, there were no significant differences in WOMAC scores or complication rates between the two implant types, suggesting that both implants are safe options for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of short-time functional outcomes after TKA between Multigen Plus CR and Physica KR prostheses. Lisý, P., Čabala, J., Hrubina, M., et al.[2023]

In a study of 671 patients who underwent primary total knee arthroplasty, there were no significant differences in patient-reported outcomes between cruciate-retaining (CR) and posterior-stabilized (PS) implants, indicating that retaining the posterior cruciate ligament does not affect patients' awareness of their artificial joint.

However, patients with constrained liners (CoN) showed significantly higher Forgotten Joint Scores (FJS-12) at one and two years post-surgery compared to those with non-constrained liners (NCoN), suggesting that the type of liner constraint may influence outcomes when the PCL is sacrificed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Retention of the Posterior Cruciate Ligament Lead to a More "Forgotten Joint" Following Total Knee Arthroplasty? Bieganowski, T., Fiedler, B., Singh, V., et al.[2022]

In a study of 39 patients one year after total knee arthroplasty, both the cruciate-retaining and anterior-stabilized prosthetic designs exhibited similar kinematic patterns during movement, indicating that they behave similarly in terms of contact-point translations.

The posterior-stabilized design, however, showed a different kinematic pattern that was more comparable to a native knee, suggesting that it may provide a more natural movement compared to the other designs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the in-vivo kinematics of three different knee prosthesis designs during a step-up movement. Rehman, Y., Koster, LA., Röhrl, SM., et al.[2022]

In a study of 16 patients, the posterior stabilized (PS) total knee arthroplasty (TKA) design showed a wider anterior translation in the lateral femoral compartment compared to the medial compartment, indicating different kinematic behaviors between the two designs.

The cruciate retaining (CR) TKA design demonstrated a more stable kinematic profile with no anterior translation during flexion, suggesting it may provide a more consistent movement pattern compared to the PS design during activities like sit-to-stand.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

J-curve design total knee arthroplasty: the posterior stabilized shows wider medial pivot compared to the cruciate retaining during chair raising. Bontempi, M., Roberti di Sarsina, T., Marcheggiani Muccioli, GM., et al.[2021]

In a study comparing posterior cruciate ligament (PCL) retaining (CR) and sacrificing (PS) total knee arthroplasties (TKA) using 11 human knee specimens, the PS-TKA showed significantly less rotation throughout the flexion range compared to the CR-TKA, indicating altered knee joint kinematics.

The PS design's cam-spine mechanism did not significantly affect high flexion kinematics, as most load was shared by the implant and surrounding soft tissues, suggesting that the PS design may not provide the expected benefits in certain movements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences in knee joint kinematics and forces after posterior cruciate retaining and stabilized total knee arthroplasty. Wünschel, M., Leasure, JM., Dalheimer, P., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study involving 18 subjects with either posterior stabilized (PS) or cruciate retaining (CR) total knee arthroplasties (TKAs) where the posterior cruciate ligament (PCL) was sacrificed, no significant differences in functional stability were found during gait analysis, indicating that PCL sacrifice does not lead to instability in well-balanced CR TKAs.

The results suggest that the choice between PS and CR implants should not be solely based on concerns about instability due to PCL sacrifice, as both designs performed similarly in terms of knee function during activities like stair descent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gait analysis comparison of cruciate retaining and substituting TKA following PCL sacrifice. Joglekar, S., Gioe, TJ., Yoon, P., et al.[2013]

In a study of 73 patients with tricompartimental knee osteoarthritis, those who received a customized cruciate-retaining total knee arthroplasty (CCR-TKA) showed significant improvements in knee function and range of motion over a 5-year follow-up, with Knee Society Scores increasing from 41 to 92 and range of motion improving from 106° to 122°.

The implant demonstrated a high survivorship rate of 97.5% at an average follow-up of 2.5 years, indicating its safety and effectiveness, although further comparative studies are needed to evaluate its long-term performance against other implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Total Knee Replacement with a Customized Cruciate-Retaining Implant Design on Patient-Reported and Functional Outcomes. Steinert, AF., Schröder, L., Sefrin, L., et al.[2022]

In a study of 38 matched pairs of osteoarthritic knees after total knee replacements, both cruciate retention and posterior stabilized designs showed similar functional improvements, with 92% and 95% of patients reporting better function, respectively.

Fluoroscopic analysis indicated that the posterior stabilized design mimicked normal knee movement more closely during activities like walking and bending, despite no significant differences in clinical outcomes between the two designs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional comparison of posterior cruciate retention and substitution knee replacement. Udomkiat, P., Meng, BJ., Dorr, LD., et al.[2019]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Comparison of short-time functional outcomes after TKA between Multigen Plus CR and Physica KR prostheses. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Does Retention of the Posterior Cruciate Ligament Lead to a More "Forgotten Joint" Following Total Knee Arthroplasty? [2022]

3. England pubmed.ncbi.nlm.nih.gov

Comparison of the in-vivo kinematics of three different knee prosthesis designs during a step-up movement. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

J-curve design total knee arthroplasty: the posterior stabilized shows wider medial pivot compared to the cruciate retaining during chair raising. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Differences in knee joint kinematics and forces after posterior cruciate retaining and stabilized total knee arthroplasty. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Rotational mismatch between femoral and tibial components should be avoided in JOURNEY II bi-cruciate stabilized total knee arthroplasty. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Preoperative and intraoperative factors contributing to patient satisfaction after bi-cruciate stabilized total knee arthroplasty. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Influence of surgical factors on patient satisfaction after bi-cruciate stabilized total knee arthroplasty: retrospective examination using multiple regression analysis. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Gait analysis comparison of cruciate retaining and substituting TKA following PCL sacrifice. [2013]

10. Switzerland pubmed.ncbi.nlm.nih.gov

The Impact of Total Knee Replacement with a Customized Cruciate-Retaining Implant Design on Patient-Reported and Functional Outcomes. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Functional comparison of posterior cruciate retention and substitution knee replacement. [2019]