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Completed

NCT Number: NCT04173377

Elbow Outcomes Clinical Study (WELBOW)

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

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Key information

Conditions

Orthopedic Disorder Musculoskeletal Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AZ Herentals, Herentals, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Clinical Assessment: QuickDASH questionnaire

    Time frame: At 24 months

    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).

Secondary outcomes

  1. Safety and Tolerability : Number of device associated and procedure associated adverse events.

    Time frame: Up to 10 years.

    Number of device associated and procedure associated adverse events.

  2. 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).

  3. Clinical Assessment: MEPS questionnaire

    Time frame: From Baseline to 10 years except 7 years.

    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

  4. 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).

  5. Clinical Assessment: Range of Motion

    Time frame: From Baseline to 10 years except 7 years.

    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.

  6. Clinical Assessment: Strength

    Time frame: From Baseline to 10 years except 7 years.

    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.

  7. Clinical Assessment: Patient's Satisfaction

    Time frame: From Baseline to 10 years except 7 years.

    • 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)".

  8. Radiologic Assessment for bone characteristics

    Time frame: Before surgery, at 3 months for Osteosynthesis and 1, 2, 5 and 10 years for Arthroplasties.

    Imaging (X-ray, CT scan or MRI) will be analyzed, when sufficient information is available, for bone characteristics

  9. Radiologic Assessment for device migration

    Time frame: Before surgery, at 3 months for Osteosynthesis and 1, 2, 5 and 10 years for Arthroplasties.

    Imaging (X-ray, CT scan or MRI) will be analyzed, when sufficient information is available, for device migration

Sponsors and collaborators

Lead sponsor

Stryker Trauma and Extremities

Industry

Registry information

Acronym: WELBOW

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Nov 21, 2019
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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