Elbow Outcomes Clinical Study (WELBOW)

Stryker Trauma and Extremities

Status: Completed

Conditions: Orthopedic Disorder

Study type: Observational

Funder types: Industry

Identifiers

NCT04173377

1801-T-WELBOW-RM

2019-A00492-55 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 310 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.