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Clinical Study Evaluating the Outcomes of a New Knee System with a Physiological Rollback Mechanism | Clinical Trials | Clareo Health

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Clinical Study Evaluating the Outcomes of a New Knee System with a Physiological Rollback Mechanism

A Multicentre, Prospective Clinical Study Evaluating the Outcomes of a New Knee System with a Physiological Rollback Mechanism

NCT02118272•Limacorporate S.p.a

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

22 - 80 years

Sex

ALL

Healthy Volunteers

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
+4 more criteria

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
+13 more criteria

Locations (3)

Azienda Ospedaliero-universitaria Careggi

Florence, Florence, Italy

The Royal Bournemouth Hospital, NHS Foundation Trust

Bournemouth, Dorset, United Kingdom

Dorset County Hospital NHS Foundation Trust

Dorchester, Dorset, United Kingdom

Key Dates

Start Date

May 1, 2014

Primary Completion Date

November 1, 2021

Completion Date

November 1, 2021

Last Updated

March 10, 2025

Enrollment

156

ACTUAL participants

Conditions

Primary Total Knee Replacement

Interventions

Physica KR

DEVICE