ORIGIN® vs. VANGUARD® PS Observational Study

Symbios

Status: Enrolling

Conditions: Arthroplasty; Knee; Replacement

Treatments: Device: VANGUARD PS System; Device: ORIGIN PS System

Study type: Observational

Funder types: Industry

Identifiers

NCT04728542

CLIN-G-010

2019-14580 (Other Identifier)

Details and patient eligibility

About

The study objective is to assess patient satisfaction after the surgery with a patient match CE marked implant (ORIGIN®) versus off-the-shelf (VANGUARD PS) device, and to document the clinical and device performance outcomes of the ORIGIN System used in routine hospital practice in a large patient cohort treatment of total knee arthroplasty.

Full description

This is a prospective, comparative, randomized, double arm, monocentric, observational, post-market study with 140 subjects with 2 years follow-up.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion/exclusion criteria

Trial design

140 participants in 2 patient groups

Origine

Description:

70 subjects with the ORIGIN PS System

Treatment:

Device: ORIGIN PS System

Vanguard

Description:

70 subjects with the VANGUARD System

Treatment:

Device: VANGUARD PS System