Elbow Outcomes Clinical Study (WELBOW)

Orthopedic Disorder Clinical Trial

— WELBOW  

Official title:

Elbow Outcomes Clinical Study (WELBOW)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04173377
• Other study ID #: 1801-T-WELBOW-RM
• Secondary ID: 2019-A00492-55
• Status: Recruiting
• Start date: June 8, 2020
• Est. completion date: June 2034

Study information

• Verified date: April 2024
• Source: Stryker Trauma GmbH
• Contact: Amjad Uneisi
• Phone: +33638213703
• Email: amjad.uneisi[@]stryker.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: June 2034
• Est. primary completion date: June 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

1. 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.

2. 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.

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Orthopedic Disorder

Locations

Country	Name	City	State
Belgium	AZ Herentals	Herentals
Canada	Lawson Health Research Institute	London
France	CHU Bordeaux	Bordeaux
France	Clinique du parc	Lyon
France	Rouen University Hospital	Rouen
France	CHU Tours	Tours
Sweden	Linköping University	Linköping
Sweden	Sjukhuset i Varberg Hospital	Varberg
United Kingdom	Wrightington Hospital	Wigan	Lancashire

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Trauma GmbH

Countries where clinical trial is conducted

Belgium,  Canada,  France,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Safety and Tolerability : Number of device associated and procedure associated adverse events.	Number of device associated and procedure associated adverse events.	Up to 10 years.
Secondary	Implant Survivorship	Rates of revision surgeries; assessed using the Kaplan-Meyer analysis. Censorship will be at the point of the last patient event (visit, death, revision).	At 2, 5, 7 and 10 years.
Secondary	Clinical Assessment: MEPS questionnaire	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	From Baseline to 10 years except 7 years.
Secondary	Clinical Assessment: QuickDASH questionnaire	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).	From Baseline to 10 years except 7 years.
Secondary	Clinical Assessment: Range of Motion	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.	From Baseline to 10 years except 7 years.
Secondary	Clinical Assessment: Strength	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.	From Baseline to 10 years except 7 years.
Secondary	Clinical Assessment: Patient's Satisfaction	Single subjective question: "How satisfied are you with your elbow?" Response options include: "Very Satisfied, Satisfied, Dissatisfied, and Very Dissatisfied".; Subjective value: "How would you rate your elbow today as a percentage of normal? (0 to 100% scale with 100% being normal)".	From Baseline to 10 years except 7 years.
Secondary	Radiologic Assessment for bone characteristics	Imaging (X-ray, CT scan or MRI) will be analyzed, when sufficient information is available, for bone characteristics	Before surgery, at 3 months for Osteosynthesis and 1, 2, 5 and 10 years for Arthroplasties.
Secondary	Radiologic Assessment for device migration	Imaging (X-ray, CT scan or MRI) will be analyzed, when sufficient information is available, for device migration	Before surgery, at 3 months for Osteosynthesis and 1, 2, 5 and 10 years for Arthroplasties.