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 @ 12:54 AM
Ignite Modification Date:
2025-12-25 @ 12:54 AM
NCT ID:
NCT04364867
Eligibility Criteria:
Inclusion Criteria:
* Patients undergoing unilateral primary TSA or reverse TSA
* Indication for surgery is osteoarthritis, rotator cuff arthropathy or massive irreparable rotator cuff tears
* Surgery performed by the Principal Investigator
* Anesthesia administered by Co-Principal Investigator
* Willing and able to sign an Informed Consent
Exclusion criteria
* Indication for surgery is fracture
* Comorbid psychiatric diagnosis requiring therapy and/or medication except anxiety or depression
* Comorbid chronic pain syndrome (reflex sympathetic dystrophy, fibromyalgia)
* Has hepatic disease
* On workers compensation/disability/litigation
* Known adverse reaction to medications to be administered
* On long-acting narcotic pain medication (including extended release narcotic pain medications and methadone)
* Home Oxygen requirement whether as needed or scheduled.
* Contralateral Phrenic Nerve paralysis / incompetence.
* Body Mass Index ≥ 50
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04364867
Study Brief:
Protocol Section:
NCT04364867