ORIGIN® vs. VANGUARD® PS Observational Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ORIGIN PS System, VANGUARD PS System.
- Who it may be relevant to
- Registry conditions: Arthroplasty, Replacement, Knee. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Post-market Observational ORIGIN® vs. VANGUARD® PS Clinical Study: a Comparative, Prospective, Randomized Controlled Clinical and Radiological Evaluation.
Overview
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.
Detailed description
This is a prospective, comparative, randomized, double arm, monocentric, observational, post-market study with 140 subjects with 2 years follow-up.
Interventions
- Device ORIGIN PS System
70 surgeries with the ORIGIN PS System - Device VANGUARD PS System
70 surgeries with the VANGUARD System
Primary outcome measures
- Forgotten Joint Score [Time frame: Preoperative, 1 year, and 2 years visits]
- The Self-Administered Patient Satisfaction Scale [Time frame: Preoperative, 1 year, and 2 years visits]
Secondary outcome measures (5)
- Oxford Knee Score (OKS) [Time frame: Preoperative, 1 year, and 2 years visits]
- EQ-5D-5L [Time frame: Preoperative, 1 year, and 2 years visits]
- Knee Society clinical rating system (KSS) Objective Knee Indicators [Time frame: Preoperative, 1 year, and 2 years visits]
- Single Leg Stance test [Time frame: Preoperative, 1 year, and 2 years visits]
- Time Up & Go tests [Time frame: Preoperative, 1 year, and 2 years visits]
Eligibility criteria
Inclusion/exclusion criteria
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- University Medical Center of Johannes Gutenberg-University Mainz — Mainz
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. PMID 29108793
- 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. PMID 30765928
- 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. PMID 31256639
Identifiers
NCT: NCT04728542 · CLIN-G-010 · 2019-14580