- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04173377
Elbow Outcomes Clinical Study (WELBOW) (WELBOW)
April 9, 2024 updated by: Stryker Trauma GmbH
WELBOW study is an international, ambispective and prospective, single arm, multicenter, observational, non-comparative, Post-Market Clinical Follow-up (PMCF).
Study Overview
Status
Recruiting
Conditions
Detailed 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.
Study Type
Observational
Enrollment (Estimated)
800
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Amjad Uneisi
- Phone Number: +33638213703
- Email: amjad.uneisi@stryker.com
Study Locations
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-
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Herentals, Belgium
- Recruiting
- AZ Herentals
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Principal Investigator:
- Frederic DE SCHRIJVER, Dr
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London, Canada
- Recruiting
- Lawson Health Research Institute
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Principal Investigator:
- Graham KING, Pr
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-
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Bordeaux, France, 33000
- Recruiting
- CHU Bordeaux
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Principal Investigator:
- Alexandra ERBLAND, Dr
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Lyon, France
- Recruiting
- Clinique du Parc
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Principal Investigator:
- Christophe RIZZO, Dr
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Rouen, France, 76031
- Recruiting
- Rouen University Hospital
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Principal Investigator:
- Fabrice DUPARC, Pr
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Tours, France
- Recruiting
- Chu Tours
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Principal Investigator:
- Guillaume BACLE, Dr
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-
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Linköping, Sweden, 581 83
- Withdrawn
- Linköping University
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Varberg, Sweden, 432 37
- Withdrawn
- Sjukhuset i Varberg Hospital
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-
-
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Lancashire
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Wigan, Lancashire, United Kingdom, WN6 9EP
- Recruiting
- Wrightington Hospital
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Principal Investigator:
- Adam WATTS, Pr
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients from Europe (United Kingdom, France, Germany, Sweden, Belgium)
Description
Inclusion Criteria:
- 18 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.
- For prospective inclusion: Considered for treatment with one Wright Medical Elbow arthroplasty or fracture devices included in this study (primary or revision).
For ambispective inclusion
- 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)*.
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 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Assessment: QuickDASH questionnaire
Time Frame: At 24 months
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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).
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At 24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Implant Survivorship
Time Frame: At 2, 5, 7 and 10 years.
|
Rates of revision surgeries; assessed using the Kaplan-Meyer analysis.
Censorship will be at the point of the last patient event (visit, death, revision).
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At 2, 5, 7 and 10 years.
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Clinical Assessment: QuickDASH questionnaire
Time Frame: From Baseline to 10 years except 7 years.
|
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).
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From Baseline to 10 years except 7 years.
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Clinical Assessment: Range of Motion
Time Frame: From Baseline to 10 years except 7 years.
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Range of Motion (ROM) is a movement test conducted on a joint to diagnose level of pain and function.
Flexion / Extension, Supination and Pronation will be evaluated.
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From Baseline to 10 years except 7 years.
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Clinical Assessment: Strength
Time Frame: From Baseline to 10 years except 7 years.
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Elbow strength will be measured with the MRC Strenght Scale The MRC Strength Scale is a 5-items scale.
The muscle scale grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle.
Grade 5 shows normal contraction of the muscle, Grade 0 shows no movement.
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From Baseline to 10 years except 7 years.
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Clinical Assessment: Patient's Satisfaction
Time Frame: From Baseline to 10 years except 7 years.
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From Baseline to 10 years except 7 years.
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Safety and Tolerability : Number of device associated and procedure associated adverse events.
Time Frame: Up to 10 years.
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Number of device associated and procedure associated adverse events.
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Up to 10 years.
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Clinical Assessment: MEPS questionnaire
Time Frame: From Baseline to 10 years except 7 years.
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Clinician based index with 4 subscales and 8 items (pain, range of motion, stability, daily function), measured with a goniometer.
MEPS ranges from 5 to 100 points which higher scores indicates better function.
A total score between 90 and 100 points considered excellent; between 75 and 89 points, good; between 60 and 74 points; fair, less than 60 points, poor
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From Baseline to 10 years except 7 years.
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Radiologic Assessment for bone characteristics
Time Frame: Before surgery, at 3 months for Osteosynthesis and 1, 2, 5 and 10 years for Arthroplasties.
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Imaging (X-ray, CT scan or MRI) will be analyzed, when sufficient information is available, for bone characteristics
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Before surgery, at 3 months for Osteosynthesis and 1, 2, 5 and 10 years for Arthroplasties.
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Radiologic Assessment for device migration
Time Frame: Before surgery, at 3 months for Osteosynthesis and 1, 2, 5 and 10 years for Arthroplasties.
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Imaging (X-ray, CT scan or MRI) will be analyzed, when sufficient information is available, for device migration
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Before surgery, at 3 months for Osteosynthesis and 1, 2, 5 and 10 years for Arthroplasties.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Rebecca Gibson, Stryker Trauma
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 8, 2020
Primary Completion (Estimated)
June 1, 2030
Study Completion (Estimated)
June 1, 2034
Study Registration Dates
First Submitted
November 20, 2019
First Submitted That Met QC Criteria
November 20, 2019
First Posted (Actual)
November 21, 2019
Study Record Updates
Last Update Posted (Actual)
April 11, 2024
Last Update Submitted That Met QC Criteria
April 9, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1801-T-WELBOW-RM
- 2019-A00492-55 (Other Identifier: French National Health Agency)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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