Cryoneurolysis of the Suprascapular Nerve for Perioperative Pain Control After Receiving a Reverse Total Shoulder Arthroplasty (RTSA)
Recruiting now · Not applicable
Conditions studied: Degenerative Joint Disease of Shoulder
In brief
The main purpose of this research is to find out if a treatment called cryoneurolysis can reduce pain after reverse total shoulder replacement surgery. This treatment uses cold to temporarily block a nerve in the shoulder. The study will compare people who receive the treatment to those who do not, to see if it helps lower pain and reduce the need for opioid pain medications after a reverse total shoulder surgery (RTSA).
Key facts
- Study ID
- NCT07125833
- Run by
- North Texas Medical Research Institute, PLLC
- People needed
- 20
- Starts
- 2025-07-30
- Expected to finish
- 2026-08-01
- Last updated by the study team
- 2025-08-15
Who can join
Age: 30 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Orthopaedic Specialists of Dallas — Rockwall, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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