Clinical Study Evaluating the Outcomes of a New Knee System with a Physiological Rollback Mechanism (K-06)

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.

Study Overview

• Status: Terminated
• Conditions: Primary Total Knee Replacement
• Intervention / Treatment: Device: Physica KR

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Florence, Italy, 50134
    • Azienda Ospedaliero-Universitaria Careggi
• United Kingdom
  • Dorset
    • Bournemouth, Dorset, United Kingdom, BH7 7DW
      • The Royal Bournemouth Hospital, NHS Foundation Trust
    • Dorchester, Dorset, United Kingdom, DT1 2JY
      • Dorset County Hospital Nhs Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male and females
2. Age 22-80 years
3. Any race
4. Ambulatory patients
5. Patients who have a medical condition with over 5 years of life expectancy
6. Patients requiring knee prosthesis, suitable for the use of Physica KR
7. Patients with painful primary knee osteoarthritis
8. Patients with painful secondary knee osteoarthritis
9. Patients who are suffering from inflammatory arthritis (e.g. rheumatoid arthritis)
10. Patients who have undamaged and functional collateral and posterior cruciate ligaments
11. Patients with a flexion greater than or equal to 90° on the affected side
12. Patients with a fixed flexion contracture less than 10°
13. 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
14. Patients who have signed the Ethics Committee approved study-specific Informed Consent Form prior to the surgery

Exclusion Criteria:

1. Obese patients with BMI above 35 kg/m2 (severe obesity)
2. Previous partial knee replacement (unilateral, bicompartimental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or femoral osteotomy in the affected knee
3. Primary Total Knee Replacement (TKR) in the affected knee
4. Varus or Valgus deformity greater than 20°
5. Patients with a fixed flexion contracture greater than 10°
6. Previous knee replacement on the contralateral side within the last year and whose outcome is achieving an KSS< 70 points
7. Patients with symptomatic OA of the hips, spine, ankles, if it can interfere with the evaluation of the target knee
8. Patients with active or any suspected infection (on the affected knee or systemic)
9. Muscular insufficiency or absence of muscoligamentous supporting structures required for adequate soft tissue balance
10. Patients with known or suspicious metal hypersensitivity
11. Recurrent medical history of severe allergic or immune-mediated reactions
12. Vascular insufficiency of lower limbs severe enough to interfere with the study evaluation
13. Current treatment or treatment within the previous 2 years before the screening visit for malignant and life-threatening non-malignant disorders
14. Any clinically significant pathology based on clinical history that the Investigator feels may affect the study evaluation
15. 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
16. Patients who have significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery and evaluation
17. Patients who have neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device
18. Patients with systemic or metabolic disorders leading to progressive bone deterioration
19. Patients who have a medical condition with less 5 years of life expectancy
20. Previous organ transplant surgery
21. Any psychiatric illness that would prevent comprehension of the details and nature of the study
22. Participation in any experimental drug/device study within the 6 months prior to the screening visit
23. Female patients who are pregnant, nursing, or planning a pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Physica KR	Device: Physica KR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Knee Society Clinical Rating System (KSS)	From baseline to 5 year follow up

Secondary Outcome Measures

Outcome Measure	Time Frame
Knee injury and Osteoarthritis Outcome Score (KOOS)	From baseline to 5 year follow-up
Oxford Knee Score (OKS)	From baseline to 5 year follow-up
Satisfaction Visual Analogue Scale (VAS)	From baseline to 5 year follow-up
Survival rate of the implant	at 3 and 5 year follow-up
Incidence of AE/SAE, ADE/SADE	From baseline to 5 year follow-up
Forgotten Joint score (FJS)	From baseline to 5 year follow-up

Collaborators and Investigators

• Sponsor: Limacorporate S.p.a

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): November 1, 2021
• Study Completion (Actual): November 1, 2021

Study Registration Dates

• First Submitted: April 11, 2014
• First Submitted That Met QC Criteria: April 16, 2014
• First Posted (Estimated): April 21, 2014

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: K-06 Physica KR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No