ORIGIN® vs. VANGUARD® PS Observational Study

NCT ID: NCT04728542

Last Updated: 2024-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-25

Study Completion Date

2027-02-28

Brief Summary

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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

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

Conditions

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Arthroplasty Replacement Knee

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Origine

70 subjects with the ORIGIN PS System

ORIGIN PS System

Intervention Type DEVICE

70 surgeries with the ORIGIN PS System

Vanguard

70 subjects with the VANGUARD System

VANGUARD PS System

Intervention Type DEVICE

70 surgeries with the VANGUARD System

Interventions

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ORIGIN PS System

70 surgeries with the ORIGIN PS System

Intervention Type DEVICE

VANGUARD PS System

70 surgeries with the VANGUARD System

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Inclusion/exclusion criteria
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Symbios Orthopedie SA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe Drees, Prof

Role: PRINCIPAL_INVESTIGATOR

Johannes Gutenberg University Mainz

Locations

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University Medical Center of Johannes Gutenberg-University Mainz

Mainz, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Lukas Eckhard

Role: CONTACT

+496131177302

Facility Contacts

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Lukas Eckhard

Role: primary

Philipp Drees, Dr

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 29108793 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30765928 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31256639 (View on PubMed)

Other Identifiers

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2019-14580

Identifier Type: OTHER

Identifier Source: secondary_id

CLIN-G-010

Identifier Type: -

Identifier Source: org_study_id

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