Phase
Condition
Musculoskeletal Diseases
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
18 years or older at the time of the informed consent or the non-opposition (whenapplicable).
Informed and willing to sign an informed consent form approved by IRB or EC (whenapplicable).
Willing and able to comply with the requirements of the study protocol.
For prospective inclusion: Considered for treatment with one Wright Medical Elbowarthroplasty or fracture devices included in this study (primary or revision).
For ambispective inclusion
Must have undergone an Elbow arthroplasty or fracture with one Wright MedicalElbow 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 yearsfollow-up visit prospectively. Ambispective patients who were explanted priorthe 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
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 assessmenttimes).
Patient belongs to a vulnerable group of patients, including minor patients, thoseunable to decide for themselves to participate or needing a Legally AuthorizedRepresentative (LAR), or others who could be subject to coercion (patients who maynot be acting on their own initiative) (referred as "vulnerable subject" in thesection 3.44 of the ISO 14155:2011 norm).
Patient with previous elbow device(s) which remain(s) implanted.
Study Design
Study Description
Connect with a study center
AZ Herentals
Herentals,
BelgiumSite Not Available
Lawson Health Research Institute
London,
CanadaSite Not Available
CHU Bordeaux
Bordeaux, 33000
FranceSite Not Available
Clinique du parc
Lyon,
FranceSite Not Available
Rouen University Hospital
Rouen, 76031
FranceSite Not Available
CHU Tours
Tours,
FranceSite Not Available
Linköping University
Linköping, 581 83
SwedenSite Not Available
Sjukhuset i Varberg Hospital
Varberg, 432 37
SwedenSite Not Available
Wrightington Hospital
Wigan, Lancashire WN6 9EP
United KingdomSite Not Available
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