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

Limacorporate S.p.a3 sites in 2 countries156 target enrollmentMay 2014

ConditionsPrimary Total Knee Replacement

Overview

Phase: N/A
Intervention: Not specified
Conditions: Primary Total Knee Replacement
Sponsor: Limacorporate S.p.a
Enrollment: 156
Locations: 3
Primary Endpoint: Knee Society Clinical Rating System (KSS)
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

May 2014

End Date

November 2021

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Limacorporate S.p.a

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and females
•Age 22-80 years
•Ambulatory patients
•Patients who have a medical condition with over 5 years of life expectancy
•Patients requiring knee prosthesis, suitable for the use of Physica KR
•Patients with painful primary knee osteoarthritis
•Patients with painful secondary knee osteoarthritis
•Patients who are suffering from inflammatory arthritis (e.g. rheumatoid arthritis)
•Patients who have undamaged and functional collateral and posterior cruciate ligaments
•Patients with a flexion greater than or equal to 90° on the affected side

Exclusion Criteria

•Obese patients with BMI above 35 kg/m2 (severe obesity)
•Previous partial knee replacement (unilateral, bicompartimental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or femoral osteotomy in the affected knee
•Primary Total Knee Replacement (TKR) in the affected knee
•Varus or Valgus deformity greater than 20°
•Patients with a fixed flexion contracture greater than 10°
•Previous knee replacement on the contralateral side within the last year and whose outcome is achieving an KSS\< 70 points
•Patients with symptomatic OA of the hips, spine, ankles, if it can interfere with the evaluation of the target knee
•Patients with active or any suspected infection (on the affected knee or systemic)
•Muscular insufficiency or absence of muscoligamentous supporting structures required for adequate soft tissue balance
•Patients with known or suspicious metal hypersensitivity

Outcomes

Primary Outcomes

Knee Society Clinical Rating System (KSS)

Time Frame: From baseline to 5 year follow up

Secondary Outcomes

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