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:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT00764504
Eligibility Criteria:
Inclusion Criteria:
* Irreparable rotator cuff or failed hemi or total shoulder arthroplasty with irreparable rotator cuff
* Evidence of upward displacement of the humeral head with respect to the glenoid
* Loss of glenohumeral joint space
* Functional deltoid muscle
* Patient is likely to be available for evaluation for the duration of the study
* Visual Analog Pain Scale 5 or greater
Exclusion Criteria:
* Non functional deltoid muscle
* Active sepsis
* Excessive glenoid bone loss
* Pregnancy
* Neurological abnormalities, which could hinder patient's ability or willingness to follow study procedures. For example, any that may restrict physical activities such as Parkinson's, Multiple Sclerosis, or previous stroke, which affects upper extremity.
* Mental conditions that may interfere with ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the patient cannot understand the informed consent process, global dementia, prior strokes that interfere with the patient's cognitive abilities, senile dementia, and Alzheimer's Disease.
* Prisoners
* Conditions that place excessive demand on the implant (i.e. Charcot's joints, muscle deficiencies, refusal to modify postoperative physical activities, skeletal immaturity).
* Known metal allergy (i.e., jewelry).
* Visual Analog Pain Scale \<5.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00764504
Study Brief:
Protocol Section:
NCT00764504