Orthopedic DisorderWELBOWNCT04173377
Elbow Outcomes Clinical Study (WELBOW)
An observational study of Orthopedic Disorder, run by Stryker Trauma and Extremities at 7 sites in 4 countries.
Trial summary
WELBOW study is an international, ambispective and prospective, single arm, multicenter, observational, non-comparative, Post-Market Clinical Follow-up (PMCF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopedic Disorder
- How many people
- 310 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 8 Jun 2020to 17 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from Europe (United Kingdom, France, Germany, Sweden, Belgium) and Canada
Who may be able to join
- 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)*.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
France4 sites
CHU Bordeaux
Bordeaux, 33000
Clinique du parc
Lyon
CHU de Rouen
Rouen, 76031
CHU Tours
Tours
About this study
WELBOW study is an international, ambispective and prospective, single arm, multicenter, observational, non-comparative, Post-Market Clinical Follow-up (PMCF).
Read the 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.
- Conditions
- Orthopedic Disorder
- Keywords
- Orthopedic Surgery, Elbow, Trauma, Arthroplasty, Osteosynthesis
- Medical subject headings
- Musculoskeletal Diseases, Wounds and Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At 24 months
Secondary outcomes (9)
Safety and Tolerability : Number of device associated and procedure associated adverse events.
Number of device associated and procedure associated adverse events.
Measured: 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).
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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)".
Measured: 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
Measured: 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
Measured: Before surgery, at 3 months for Osteosynthesis and 1, 2, 5 and 10 years for Arthroplasties.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start8 Jun 2020
- Primary completion17 Sep 2024
- Study completion17 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Trauma and Extremities
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rebecca Gibson, Study director, Stryker Trauma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173377
- Sponsor's protocol ID
- 1801-T-WELBOW-RM
- Other IDs
- 2019-A00492-55
- Acronym
- WELBOW
- Status last verified
- Sep 2025
- First submitted
- 20 Nov 2019
- Last updated
- 16 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elbow Outcomes Clinical Study (WELBOW)
- ClinicalTrials.gov ID
- NCT04173377
- Acronym / sponsor ID
- WELBOW / 1801-T-WELBOW-RM
- Conditions
- Orthopedic Disorder
- Keywords
- Orthopedic Surgery, Elbow, Trauma, Arthroplasty, Osteosynthesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Stryker Trauma and ExtremitiesIndustry (pharma, biotech, devices)
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 17 Sep 2024 (actual)
- Study completion
- 17 Sep 2024 (actual)
- First posted
- 21 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
WELBOW study is an international, ambispective and prospective, single arm, multicenter, observational, non-comparative, Post-Market Clinical Follow-up (PMCF).
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from Europe (United Kingdom, France, Germany, Sweden, Belgium) and Canada
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
9 secondary outcomes
Safety and Tolerability : Number of device associated and procedure associated adverse events.
Time frame: Up to 10 years.
Implant Survivorship
Time frame: At 2, 5, 7 and 10 years.
Clinical Assessment: MEPS questionnaire
Time frame: From Baseline to 10 years except 7 years.
Clinical Assessment: QuickDASH questionnaire
Time frame: From Baseline to 10 years except 7 years.
Clinical Assessment: Range of Motion
Time frame: From Baseline to 10 years except 7 years.
Clinical Assessment: Strength
Time frame: From Baseline to 10 years except 7 years.
Clinical Assessment: Patient's Satisfaction
Time frame: From Baseline to 10 years except 7 years.
Radiologic Assessment 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
Time frame: Before surgery, at 3 months for Osteosynthesis and 1, 2, 5 and 10 years for Arthroplasties.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Orthopedic Disorder
Not yet recruitingPhase 3
A Study to Understand How Nerandomilast Works in People With Active Idiopathic Inflammatory Myopathies
Idiopathic Inflammatory Myopathies
Active, not recruitingObservational study
Extracellular RNA Biomarkers of Myotonic Dystrophy
Myotonic Dystrophy
Not yet recruitingPhase 2
Platform Study of Targeted Therapies for Adults With Moderately to Severely Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruiting
Surface Electromyographic Analysis of Scapular Stabilizer Muscle in Postural Hyperkyphosis
Hyperkyphosis
RecruitingPhase 3
Phase 3 Pivotal Trial Comparing CARTISTEM® and Surgical Comparator for Knee Cartilage Lesions and Osteoarthritis
Knee Cartilage Defects
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Gibson study director
Stryker Trauma
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopedic Disorder, run by Stryker Trauma and Extremities at 7 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France, Belgium, Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Assessment: QuickDASH questionnaire (time frame: At 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.