Physica CR and Physica PS Clinical Trial

NCT02766231 | Active Not Recruiting

• 1 other identifier: K-09
• Study Type: observational
• Target: 157
• Locations: 3 countries
• Sites: 4

Brief Summary

Type \& Design: Post-market, international, multicentre Prospective, parallel groups, open-label, baseline controlled Objectives:

1. 1.Assessment of clinical, radiographic and patient-reported outcomes of Physica CR and PS designs
2. 2.Incidence of adverse events and identification of possible risk factors for unsatisfactory results
3. 3.Mid-term survivorship of the implants

Conditions

Knee Osteoarthritis

Keywords

knee replacement

Outcome Measures

Primary Outcomes (1)

• Clinical change in Knee Society Score (KSS)

  KSS is divided into two components: the first ("Knee Score", KKSS) assesses the knee clinically through the physical examination, and the second ("Function Score", FKSS) assesses the individual's functionality, while both attain a total of 100 points each. The Clinical KSS (KKSS) evaluates pain (50 points), stability (25 points) and range of motion (25 points). The Functional KSS (FKSS) evaluates the walking distance (50 points), and the act of climbing and descending stairs (50 points). The system for selecting patients is provided through three categories: A- unilateral or bilateral (opposite knee replaced successfully), B- unilateral, other knee symptomatic and C- polyarthritis or clinical disease. Scores rating from 80 to 100 is considered excellent, from 70 to 79 good, from 60 to 69 fair, and less than 60 poor.

  From preoperative (baseline) to 5 years after surgery

Secondary Outcomes (7)

• Functional change in Timed up and Go (TUG) test

  From preoperative (baseline) to 5 years after surgery

• Change in Knee injury and Osteoarthritis Outcome Score (KOOS)

  From preoperative (baseline) to 5 years after surgery

• Change in Satisfaction Visual Analogue Scale (Satisfaction VAS)

  From 3 months to 5 years after surgery

• Change in Forgotten Joint Score (FJS-12)

  From 3 months to 5 years after surgery

• Components stability - radiolucent lines evaluation

  From discharge to 5 years after surgery

Study Arms (2)

Physica CR

Patients who have undamaged and functional collateral and posterior cruciate ligaments for the group requiring Physica CR

Device: Physica CR

Physica PS

Patients who have undamaged and functional collateral ligaments for the group requiring Physica PS

Device: Physica PS

Interventions

Physica CR DEVICE

Cruciate retaining total knee replacement

Physica CR

Physica PS DEVICE

Posterior Stabilized total knee replacement

Physica PS

Eligibility Criteria

• Age: 22 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

General population of subjects requiring a primary TKR with a diagnosis of painful primary or secondary osteoartrithis not responding to other conservative treatments, after the review of medical history and the radiographic evaluation of the affected knee.

You may qualify if:

• Male and females
• Age 22-78 years
• Any race
• Ambulatory patients
• Patients who have a medical condition with over 5 years of life expectancy
• Patients with painful primary or secondary knee osteoarthritis
• Patients who have undamaged and functional collateral and posterior cruciate ligaments for the group requiring Physica CR or Patients who have undamaged and functional collateral ligaments for the group requiring Physica PS
• Patients with flexion ≥90° on the affected side
• Patients with a fixed flexion contracture \<20°
• 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:

• Previous partial knee replacement or patellofemoral joint replacement and previous patellectomy
• Primary Total Knee Replacement (TKR) in the affected knee
• Varus deformity \>20° or Valgus deformity \>15°
• Patients with a fixed flexion contracture \>20°
• Previous intra-articular fractures of the affected knee
• Patients with previous methaphysal tibial or femoral osteotomy performed less than 5 years before the screening visit, in case of plate removal surgery it is done early than 1 year ago to screening.
• Previous knee replacement on the contralateral side within the last year and whose outcome is achieving an KSS\< 60 points
• Patients with symptomatic Osteoarthritis (OA) of the spine if the assessment of pain with Numeric Rating Scale is \>4
• Patients with an history of infections (on the affected knee or systemic)
• Muscular insufficiency or absence of muscoligamentous supporting structures required for adequate soft tissue balance
• Patients who have damaged or absence of the posterior cruciate ligament for the group requiring Physica CR
• 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

Sponsors & Collaborators

• Limacorporate S.p.a: lead

Study Sites (4)

Cliniques Universitaires Saint-Luc ASBL

Brussels, Brussels Capital, 1200, Belgium

Location

I.R.C.C.S. Galeazzi

Milan, Milano, 20161, Italy

Location

Casa di cura Citta' di Parma

Parma, Parma, 43100, Italy

Location

Clinique d'Eich - centre Hospitalier de Luxembourg

Luxembourg, Luxembourg, 1460, Luxembourg

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Giuseppe Peretti, MD

  I.R.C.C.S. Galeazzi (Milan, Italy)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2016
• First Posted: May 9, 2016
• Study Start: February 1, 2016
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); LU (1); IT (2)