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 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT05703958
Eligibility Criteria:
Inclusion Criteria:
* Patient is indicated to receive Equinoxe Proximal Humerus Fracture Plate or has previously underwent primary surgery with Equioxe Proximal Humerus Fracture Plate
* Patient is willing to participate by complying with pre- and postoperative visit requirements
* Patient is willing to agree to be followed for up to 10 years following their index surgery
* Patient is willing and able to review and sign a study informed consent form
Exclusion Criteria:
* Osteomyelitis of the proximal humerus or scapula
* Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis
* Patient's age, weight, or activity level would cause the surgeon to expect early failure of the system
* The patient is unwilling or unable to comply with the post-operative care instructions
* Alcohol, drug, or other subtance abuse
* Any disease state that could adversaly affect the function or longevity of the implant
* Patient is pregnant
* Patient is a prisoner
* Patient has a physical or mental condition that would invalidate the results
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT05703958
Study Brief:
Protocol Section:
NCT05703958