Elbow Outcomes Clinical Study (WELBOW)

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

Detailed Description
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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.

Official Title
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Elbow Outcomes Clinical Study (WELBOW)

Conditions
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Orthopedic Disorder

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Orthopedic Surgery, Elbow, Trauma, Arthroplasty, Osteosynthesis