ORIGIN® vs. VANGUARD® PS Observational Study

NCT04728542 | Recruiting

• 2 other identifiers: CLIN-G-0102019-14580
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arthroplasty; Replacement; Knee

Keywords

Arthroplasty; Knee; Prosthesis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Oxford Knee Score (OKS)

  Preoperative, 1 year, and 2 years visits

• EQ-5D-5L

  Preoperative, 1 year, and 2 years visits

• Knee Society clinical rating system (KSS) Objective Knee Indicators

  Preoperative, 1 year, and 2 years visits

• Single Leg Stance test

  Preoperative, 1 year, and 2 years visits

• Time Up & Go tests

  Preoperative, 1 year, and 2 years visits

Study Arms (2)

Origine

70 subjects with the ORIGIN PS System

Device: ORIGIN PS System

Vanguard

70 subjects with the VANGUARD System

Device: VANGUARD PS System

Interventions

ORIGIN PS System DEVICE

70 surgeries with the ORIGIN PS System

Origine

VANGUARD PS System DEVICE

70 surgeries with the VANGUARD System

Vanguard

Eligibility Criteria

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

Study Population

Non-inflammatory degenerative and inflammatory knee joint disease

Sponsors & Collaborators

• Symbios Orthopedie SA: lead

Study Sites (1)

University Medical Center of Johannes Gutenberg-University Mainz

Mainz, 55131, Germany

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Study Officials

• Philippe Drees, Prof

  Johannes Gutenberg University Mainz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lukas Eckhard

CONTACT

+496131177302; lukas.eckhard@unimedizin-mainz.de

Study Design

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

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 28, 2021
• Study Start: March 25, 2021
• Primary Completion: February 1, 2025
• Study Completion (Estimated): February 1, 2027
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)