Trials Sponsors Conditions Drugs Pricing

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).

Sponsors & Collaborators

Stryker Trauma and Extremities
Industrylead

Study Sites (7)

AZ Herentals

Herentals, Belgium

Lawson Health Research Institute

London, Canada

CHU Bordeaux

Bordeaux, 33000, France

Clinique du parc

Lyon, France

CHU de Rouen

Rouen, 76031, France

CHU Tours

Tours, France

Wrightington Hospital

Wigan, Lancashire, WN6 9EP, United Kingdom

MeSH Terms

Conditions

Musculoskeletal DiseasesWounds and Injuries

Study Officials

Rebecca Gibson
Stryker Trauma
STUDY DIRECTOR

Enrollment

310 participants (actual enrollment reported by the registry).

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

Actual (reported)

Elbow Outcomes Clinical Study (WELBOW)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

MeSH Terms

Conditions

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

MeSH Terms

Conditions

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations