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โ† Trials
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Cryoneurolysis of the Suprascapular Nerve for Perioperative Pain Control After Receiving a Reverse Total Shoulder Arthroplasty (RTSA)

RecruitingNAAges 30 Years - 85 YearsAllNorth Texas Medical Research Institute, PLLC
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Cryoneurolysis
  • No cryoneurolysis
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Where

1 site
Orthopaedic Specialists of Dallas
Rockwall, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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