Cryoneurolysis of the suprascapular nerve to reduce pain after reverse total shoulder replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, controlled pilot trial comparing preoperative cryoneurolysis of the suprascapular nerve to no cryoneurolysis in patients undergoing elective primary reverse total shoulder arthroplasty for osteoarthritis. Participants will be randomly assigned to receive the cryoneurolysis procedure before surgery or to a control group and will be followed for 90 days after surgery. The primary outcome is cumulative opioid consumption measured in morphine milligram equivalents (MMEs) over 90 days; secondary outcomes include pain scores (PADT), range of motion, and ASES shoulder scores. The trial is conducted at Orthopaedic Specialists of Dallas (Rockwall, Texas) with collaboration from Pacira Pharmaceuticals.

Why it matters

Who can join: the full rules

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

Where it's running

• Orthopaedic Specialists of Dallas
  Rockwall, Texas, United States Recruiting

Study contacts

• Principal investigator: Mohammad U Burney, MD — North Texas Medical Research Institute, PLLC
• Study coordinator: Jeff Neumann, PA-C
• Email: jneumann@dallasortho.net
• Phone: 972-503-9495

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.