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

NCT02118272 | Terminated

• 1 other identifier: K-06 Physica KR
• Study Type: interventional
• Target: 156
• Locations: 2 countries
• Sites: 3

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.

Conditions

Primary Total Knee Replacement

Outcome Measures

Primary Outcomes (1)

• Knee Society Clinical Rating System (KSS)

  From baseline to 5 year follow up

Secondary Outcomes (6)

• 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

Study Arms (1)

Physica KR

OTHER

Device: Physica KR

Interventions

Physica KR DEVICE

Physica KR

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and females
• Age 22-80 years
• Any race
• 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
• Patients with a fixed flexion contracture less than 10°
• 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
• Patients who have signed the Ethics Committee approved study-specific Informed Consent Form prior to the surgery

You may not qualify if:

• 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
• Recurrent medical history of severe allergic or immune-mediated reactions
• Vascular insufficiency of lower limbs severe enough to interfere with the study evaluation
• Current treatment or treatment within the previous 2 years before the screening visit for malignant and life-threatening non-malignant disorders
• Any clinically significant pathology based on clinical history that the Investigator feels may affect the study evaluation
• 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

Sponsors & Collaborators

• Limacorporate S.p.a: lead

Study Sites (3)

Azienda Ospedaliero-universitaria Careggi

Florence, Florence, 50134, Italy

Location

The Royal Bournemouth Hospital, NHS Foundation Trust

Bournemouth, Dorset, BH7 7DW, United Kingdom

Location

Dorset County Hospital NHS Foundation Trust

Dorchester, Dorset, DT1 2JY, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2014
• First Posted: April 21, 2014
• Study Start: May 1, 2014
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); GB (2)