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 @ 2:53 AM
Ignite Modification Date:
2025-12-25 @ 2:53 AM
NCT ID:
NCT07125833
Eligibility Criteria:
Inclusion Criteria:
* Male patients or female who are not pregnant and do not plan on future pregnancy during trial participation
* between 30-85 years of age
* BMI less than or equal to 45
* Currently setup for an elective primary reverse total shoulder arthroplasty due to primary osteoarthritis
* Ability to provide informed consent to participate in the clinical trial
* Ability to understand and communicate in English
* Willingness to comply with all study procedures
Exclusion Criteria:
* poorly controlled comorbidities that would not allow surgical intervention such as poorly controlled diabetes (HbA1C \> 8.0) renal insufficiency (eGFR \<60) poorly controlled CV disease such as CHF that is NYHA class 3 and 4
* inability to receive the intervention including contraindications:
* Cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud's disease, and open and/or infected wounds at or near the treatment site
* patients with history of total joint infection ever or any infection in the last 6 months
* ASA score \>3 and Outpatient Arthroplasty Risk Assessment (OARA; medical risk stratification scoring system to help determine day surgery vs inpatient)1 score \> 80.
* previous cryoneurolysis of the suprascapular nerve-utilization of supplemental/holistic methods specifically for pain control (e.g. cannabidiol). This will be discontinued 30 days prior to RTSA and will not be used during the duration of study participation. This will be evaluated by the Principal Investigator and study team prior to consent.
* significant anti-coagulation usage (other than aspirin) 7 days prior to treatment
* CV surgery within the last 6 months
* significant neurologic compromise (acquired or congenital/genetic) of the upper extremity to be operated on or underlying neurologic condition that would confound results in the opinion of the investigator such as a
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
85 Years
Study:
NCT07125833
Study Brief:
Protocol Section:
NCT07125833