Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-25 @ 3:16 AM
NCT ID:
NCT04258605
Eligibility Criteria:
Inclusion Criteria:
* Patient is capable of understanding the doctor's explanations, following his instructions and is able to participate in the follow-up program.
* Patient has given written consent to take part in the study by signing the "Patient Consent Form".
* Patient is 18-80 years of age, inclusive.
* Patient is skeletally mature.
* Patient requires a primary, fracture or revision reverse total shoulder replacement for the relief of pain and has significant disability due to gross rotator cuff deficiency.
* Patient's joint is anatomically and structurally suited to receive the selected implants.
* Patient has a functional deltoid muscle.
Exclusion Criteria:
* Patient is unwilling or unable to give consent or to comply with the follow-up program.
* Patients who have any condition which would in the judgement of the Investigator place the patient at undue risk or interfere with the study. Any patient who is institutionalized, or is a known drug abuser, a known alcoholic or anyone who cannot understand what is required of them.
* Patient is known to be pregnant or breastfeeding.
* Patient is a vulnerable subject.
* Patient meets at least one of the contraindications:
* Signs of infection
* Significant injury to the upper brachial plexus
* Non-functional deltoid muscle
* Insufficient quality and/or quantity of glenoid or humeral bone
* Any neuromuscular or vascular disease compromising the affected limb that would endanger the success of the intervention
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04258605
Study Brief:
Protocol Section:
NCT04258605