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

North Texas Medical Research Institute, PLLC

Status: Enrolling

Conditions: Degenerative Joint Disease of Shoulder

Treatments: Device: Cryoneurolysis; Other: No cryoneurolysis

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07125833

IIT 24-376

Details and patient eligibility

About

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).

Full description

Randomized controlled, pilot clinical trial to assess the administration of and feasibility for cyroneurolysis of the suprascapular nerve in the pre-operative setting for patients that will receive a reverse total shoulder arthroplasty (RTSA). Our primary research hypothesis is that patients who receive the intervention treatment of cryoneurolysis will experience decreased opioid usage compared to the control patient population. Primary: Assess the effectiveness and feasibility of cryoneurolysis of the suprascapular nerve performed pre-operatively for RTSA patients in reduction of the cumulative opioid consumption in the post-operative of 90 days as measured by morphine milligram equivalents (MMEs) compared to those patients who did not receive the intervention prior to a RTSA.

Secondary: Assess the effectiveness of cryoneurolysis of the suprascapular nerve performed pre-operatively for RTSA patients to show:

1. a decreased pain score as measured by a Pain Assessment Documentation Tool (PADT) score
2. increased range of motion
3. increased patient reported outcome scores via the American Shoulder and Elbow Surgeons (ASES) shoulder score when compared to those that did not receive any intervention prior to a RTSA?

Enrollment: 20 estimated patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Control

Active Comparator group

Description:

Those that do not receive cryoneurolysis of the suprascapular nerve prior to RTSA

Treatment:

Other: No cryoneurolysis

Intervention

Experimental group

Description:

Those that do receive cryoneurolysis of the suprascapular nerve prior to RTSA

Treatment:

Device: Cryoneurolysis