WELBOW study is an international, ambispective and prospective, single arm, multicenter, observational, non-comparative, Post-Market Clinical Follow-up (PMCF).
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
310
AZ Herentals
Herentals, Belgium
Lawson Health Research Institute
London, Canada
CHU Bordeaux
Bordeaux, France
Clinique du parc
Lyon, France
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).
Time frame: At 24 months
Safety and Tolerability : Number of device associated and procedure associated adverse events.
Number of device associated and procedure associated adverse events.
Time frame: 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).
Time frame: 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
Time frame: 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).
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CHU de Rouen
Rouen, France
CHU Tours
Tours, France
Wrightington Hospital
Wigan, Lancashire, United Kingdom
Time frame: 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.
Time frame: 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.
Time frame: 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)".
Time frame: 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
Time frame: 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
Time frame: Before surgery, at 3 months for Osteosynthesis and 1, 2, 5 and 10 years for Arthroplasties.