ORIGIN® vs. VANGUARD® PS Observational Study

A Post-market Observational ORIGIN® vs. VANGUARD® PS Clinical Study: a Comparative, Prospective, Randomized Controlled Clinical and Radiological Evaluation.

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.

Study Overview

• Status: Recruiting
• Conditions: Arthroplasty; Knee; Replacement
• Intervention / Treatment: Device: ORIGIN PS System; Device: VANGUARD PS System

Detailed Description

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

• Study Type: Observational
• Enrollment (Estimated): 140

Contacts and Locations

• Study Contact: Name: Lukas Eckhard; Phone Number: +496131177302; Email: lukas.eckhard@unimedizin-mainz.de

Study Locations

• Germany
  • Mainz, Germany, 55131
    • Recruiting
    • University Medical Center of Johannes Gutenberg-University Mainz
    • Contact: Lukas Eckhard
    • Contact: Philipp Drees, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Non-inflammatory degenerative and inflammatory knee joint disease

Description

Inclusion/exclusion criteria

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Origine; 70 subjects with the ORIGIN PS System	Device: ORIGIN PS System; 70 surgeries with the ORIGIN PS System
Vanguard; 70 subjects with the VANGUARD System	Device: VANGUARD PS System; 70 surgeries with the VANGUARD System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forgotten Joint Score	12 questions and measure the ability of the patient to forget their operated knee after the surgery.	Preoperative, 1 year, and 2 years visits
The Self-Administered Patient Satisfaction Scale	Patients' overall satisfaction with surgery, the extent of pain relief, the ability to perform home or yard work, and the ability to perform recreational activities.	Preoperative, 1 year, and 2 years visits

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxford Knee Score (OKS)	Patient reported scores This Quality of Life score was developed in 1998 and validated to measure pain and function after total knee replacement. It consists of 12 questions about pain, function and mobility of the knee joint. Each question scores from 1 to 5 (1 the best and 5 the worst) and the sum of all the scores is deducted from 60 points. The best total is 48 points and the worst is 0.	Preoperative, 1 year, and 2 years visits
EQ-5D-5L	Patient reported scores. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can image' and 'The worst health you can image'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.	Preoperative, 1 year, and 2 years visits
Knee Society clinical rating system (KSS) Objective Knee Indicators	Surgeon reported score. It consists of 4 questions regarding the alignment and mobility of the knee joint: "Alignment" has a maximum of 25 points and is determined on a weight-bearing AP radiograph measuring the femoral-tibial (Anatomic) axis. "Instability" allows a maximum of 25 points for a knee that is stable in the coronal and saggital axis. "Joint Motion" allows one point for each 5° of joint motion. Unlike the old scoring system that allowed a maximum of 25 points the new system allows greater than 25 points for patients with greater than 125° of motion. There are deductions for flexion contracture and extension lag. The presence of recurvatum is not specifically addressed however patients with recurvatum will have significant ligament laxity in other planes that is captured in the "Instability" category of the objective score. Maximum allowable points 25+	Preoperative, 1 year, and 2 years visits
Single Leg Stance test	Surgeon reported score. It is used to assess static postural and balance control. It is a balance assessement that is widely used in clinical settings to monitor neurological and musculoskeletal conditions. It measures the duration of exercices with eyes opened and closed in seconds.	Preoperative, 1 year, and 2 years visits
Time Up & Go tests	Surgeon reported score It is a simple test to assess a person's mobility and requires both static and dynamic balance (e.g. Getting up from a chair with armrests, Make a U turn...) The criteria are : able - unable	Preoperative, 1 year, and 2 years visits

Collaborators and Investigators

• Sponsor: Symbios Orthopedie SA
• Investigators: Principal Investigator: Philippe Drees, Prof, Johannes Gutenberg University Mainz

Publications and helpful links

General Publications

• Carlson VR, Post ZD, Orozco FR, Davis DM, Lutz RW, Ong AC. When Does the Knee Feel Normal Again: A Cross-Sectional Study Assessing the Forgotten Joint Score in Patients After Total Knee Arthroplasty. J Arthroplasty. 2018 Mar;33(3):700-703. doi: 10.1016/j.arth.2017.09.063. Epub 2017 Oct 7.
• Wheatley B, Nappo K, Fisch J, Rego L, Shay M, Cannova C. Early outcomes of patient-specific posterior stabilized total knee arthroplasty implants. J Orthop. 2018 Dec 6;16(1):14-18. doi: 10.1016/j.jor.2018.11.003. eCollection 2019 Jan-Feb.
• Kahlenberg CA, Lyman S, Joseph AD, Chiu YF, Padgett DE. Comparison of patient-reported outcomes based on implant brand in total knee arthroplasty: a prospective cohort study. Bone Joint J. 2019 Jul;101-B(7_Supple_C):48-54. doi: 10.1302/0301-620X.101B7.BJJ-2018-1382.R1.

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2021
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: January 20, 2021
• First Submitted That Met QC Criteria: January 24, 2021
• First Posted (Actual): January 28, 2021

Study Record Updates

• Last Update Posted (Actual): October 4, 2024
• Last Update Submitted That Met QC Criteria: October 3, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Arthroplasty; Knee; Prosthesis
• Other Study ID Numbers: CLIN-G-010; 2019-14580 (Other Identifier: Landersarztekammer Rheinland-Pfal)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No