Elbow Outcomes Clinical Study (WELBOW)

Last updated: November 26, 2024
Sponsor: Stryker Trauma and Extremities
Overall Status: Completed

Phase

N/A

Condition

Musculoskeletal Diseases

Treatment

N/A

Clinical Study ID

NCT04173377
1801-T-WELBOW-RM
2019-A00492-55
  • Ages > 18
  • All Genders

Study Summary

WELBOW study is an international, ambispective and prospective, single arm, multicenter, observational, non-comparative, Post-Market Clinical Follow-up (PMCF).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years or older at the time of the informed consent or the non-opposition (whenapplicable).

  • Informed and willing to sign an informed consent form approved by IRB or EC (whenapplicable).

  • Willing and able to comply with the requirements of the study protocol.

  • For prospective inclusion: Considered for treatment with one Wright Medical Elbowarthroplasty or fracture devices included in this study (primary or revision).

  • For ambispective inclusion

  1. Must have undergone an Elbow arthroplasty or fracture with one Wright MedicalElbow studied device between the date of the first Site Initiation Visit (SIV)and until 4.5 years prior this one in order to have at least the 5 yearsfollow-up visit prospectively. Ambispective patients who were explanted priorthe date of the first SIV will be included.

  2. Must have complete Information available for each completed visit (demographics, preoperative information, surgery information, device details)*.

Exclusion

Exclusion Criteria:

  • Not able to comply with the study procedures based on the judgment of the assessor (e.g. cannot comprehend study questions, inability to keep scheduled assessmenttimes).

  • Patient belongs to a vulnerable group of patients, including minor patients, thoseunable to decide for themselves to participate or needing a Legally AuthorizedRepresentative (LAR), or others who could be subject to coercion (patients who maynot be acting on their own initiative) (referred as "vulnerable subject" in thesection 3.44 of the ISO 14155:2011 norm).

  • Patient with previous elbow device(s) which remain(s) implanted.

Study Design

Total Participants: 310
Study Start date:
June 08, 2020
Estimated Completion Date:
September 13, 2024

Study Description

WELBOW study is an international, ambispective and prospective, single arm, multicenter, observational, non-comparative, Post-Market Clinical Follow-up (PMCF). Outcome data collected from this study will provide the basis for Post-Market Surveillance (PMS) reporting, Clinical Study Report (CSR) and Clinical Evaluation Report (CER) on Elbow system devices and support peer-reviewed publications on long-term product performance and safety.

Connect with a study center

  • AZ Herentals

    Herentals,
    Belgium

    Site Not Available

  • Lawson Health Research Institute

    London,
    Canada

    Site Not Available

  • CHU Bordeaux

    Bordeaux, 33000
    France

    Site Not Available

  • Clinique du parc

    Lyon,
    France

    Site Not Available

  • Rouen University Hospital

    Rouen, 76031
    France

    Site Not Available

  • CHU Tours

    Tours,
    France

    Site Not Available

  • Linköping University

    Linköping, 581 83
    Sweden

    Site Not Available

  • Sjukhuset i Varberg Hospital

    Varberg, 432 37
    Sweden

    Site Not Available

  • Wrightington Hospital

    Wigan, Lancashire WN6 9EP
    United Kingdom

    Site Not Available

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