Clinical trial NCT04173377: Elbow Outcomes Clinical Study (WELBOW)
Official title: Elbow Outcomes Clinical Study (WELBOW)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orthopedic Disorder
Keywords: Orthopedic Surgery
Elbow
Trauma
Arthroplasty
Osteosynthesis
Lead sponsor: Stryker Trauma and Extremities
Sponsor class: INDUSTRY
First posted: 2019-11-21
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from Europe (United Kingdom, France, Germany, Sweden, Belgium)

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Assessment: QuickDASH questionnaire
timeFrame: At 24 months
Secondary outcomes:
measure: Safety and Tolerability : Number of device associated and procedure associated adverse events.
timeFrame: Up to 10 years.
measure: Implant Survivorship
timeFrame: At 2, 5, 7 and 10 years.
measure: Clinical Assessment: MEPS questionnaire
timeFrame: From Baseline to 10 years except 7 years.
measure: Clinical Assessment: QuickDASH questionnaire
timeFrame: From Baseline to 10 years except 7 years.
measure: Clinical Assessment: Range of Motion
timeFrame: From Baseline to 10 years except 7 years.
measure: Clinical Assessment: Strength
timeFrame: From Baseline to 10 years except 7 years.
measure: Clinical Assessment: Patient's Satisfaction
timeFrame: From Baseline to 10 years except 7 years.
measure: Radiologic Assessment for bone characteristics
timeFrame: Before surgery, at 3 months for Osteosynthesis and 1, 2, 5 and 10 years for Arthroplasties.
measure: Radiologic Assessment for device migration
timeFrame: Before surgery, at 3 months for Osteosynthesis and 1, 2, 5 and 10 years for Arthroplasties.
Other outcomes:
Locations:
city: Herentals
country: Belgium
facility: AZ Herentals
city: London
country: Canada
facility: Lawson Health Research Institute
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Lyon
country: France
facility: Clinique du parc
city: Rouen
country: France
facility: Rouen University Hospital
city: Tours
country: France
facility: CHU Tours
city: Wigan
country: United Kingdom
facility: Wrightington Hospital
state: Lancashire
Study officials:
affiliation: Stryker Trauma
name: Rebecca Gibson
role: STUDY_DIRECTOR
References: