NCT04173377

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
310

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Longer than P75 for all trials

Geographic Reach
4 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 21, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

June 8, 2020

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2024

Completed
Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

4.3 years

First QC Date

November 20, 2019

Last Update Submit

September 9, 2025

Conditions

Orthopedic Disorder

Keywords

Orthopedic SurgeryElbowTraumaArthroplastyOsteosynthesis

Outcome Measures

Primary Outcomes (1)

  • Clinical Assessment: QuickDASH questionnaire

    Demonstrate a superior (lower) Total QuickDASH score average at 24 months postoperative compared to the upper threshold of 49 points The QuickDASH is an abbreviated 11-question subset from the original Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire. The questionnaire's answers are scored on a 1-5 points scale that is then transformed to result in a score that ranges from 0 (indicating least disability) to 100 (indicating most disability).

    At 24 months

Secondary Outcomes (9)

  • Safety and Tolerability : Number of device associated and procedure associated adverse events.

    Up to 10 years.

  • Implant Survivorship

    At 2, 5, 7 and 10 years.

  • Clinical Assessment: MEPS questionnaire

    From Baseline to 10 years except 7 years.

  • Clinical Assessment: QuickDASH questionnaire

    From Baseline to 10 years except 7 years.

  • Clinical Assessment: Range of Motion

    From Baseline to 10 years except 7 years.

  • +4 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients from Europe (United Kingdom, France, Germany, Sweden, Belgium) and Canada

You may qualify if:

  • years or older at the time of the informed consent or the non-opposition (when applicable).
  • Informed and willing to sign an informed consent form approved by IRB or EC (when applicable).
  • Willing and able to comply with the requirements of the study protocol.
  • Must have undergone an Elbow arthroplasty or fracture with one Wright Medical Elbow 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 years follow-up visit prospectively. Ambispective patients who were explanted prior the date of the first SIV will be included.
  • Must have complete Information available for each completed visit (demographics, preoperative information, surgery information, device details)\*.

You may not qualify if:

  • 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 assessment times).
  • Patient belongs to a vulnerable group of patients, including minor patients, those unable to decide for themselves to participate or needing a Legally Authorized Representative (LAR), or others who could be subject to coercion (patients who may not be acting on their own initiative) (referred as "vulnerable subject" in the section 3.44 of the ISO 14155:2011 norm).
  • Patient with previous elbow device(s) which remain(s) implanted.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

AZ Herentals

Herentals, Belgium

Location

Lawson Health Research Institute

London, Canada

Location

CHU Bordeaux

Bordeaux, 33000, France

Location

Clinique du parc

Lyon, France

Location

CHU de Rouen

Rouen, 76031, France

Location

CHU Tours

Tours, France

Location

Wrightington Hospital

Wigan, Lancashire, WN6 9EP, United Kingdom

Location

MeSH Terms

Conditions

Musculoskeletal DiseasesWounds and Injuries

Study Officials

  • Rebecca Gibson

    Stryker Trauma

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2019

First Posted

November 21, 2019

Study Start

June 8, 2020

Primary Completion

September 17, 2024

Study Completion

September 17, 2024

Last Updated

September 16, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)CA(1)GB(1)FR(4)