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

NCT07125833 | Recruiting FDA Device

• 1 other identifier: IIT 24-376
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Degenerative Joint Disease of Shoulder

Keywords

cryoneurolysis; degenerative joint disease; reverse shoulder arthroplasty

Outcome Measures

Primary Outcomes (1)

• The primary endpoint for the primary objective would be decreased opioid utilization in the post-operative period after a reverse total shoulder arthroplasty (RTSA) as measured by Morphine Milligram Equivalents (MME).

  Pain medication usage as recorded by MME. MME is calculated by multiplying the opioid dose (in mg) by a drug-specific conversion factor (e.g., oxycodone × 1.5, hydromorphone × 4, fentanyl patch mcg/hr × 2.4). In research and clinical practice, MME helps quantify total opioid burden, assess risk for overdose, and standardize analgesic reporting in clinical trials. Higher daily MMEs are associated with increased adverse event risk. This will be recorded at every clinical visit.

  90 days

Secondary Outcomes (3)

• Decreased Pain Assessment and Documentation Tool (PADT) scores

  90 days

• Improved range of motion (ROM) of the shoulder as measured by the investigators and physical therapy documentation

  90 days

• Decreased American Shoulder and Elbow Surgeons (ASES) patient reported outcomes

  90 days

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Other: No cryoneurolysis

Intervention

EXPERIMENTAL

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

Device: Cryoneurolysis

Interventions

Cryoneurolysis DEVICE

Cryoneurolysis of the suprascapular nerve

Intervention

No cryoneurolysis OTHER

Control Group

Control

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• North Texas Medical Research Institute, PLLC: lead
• Pacira Pharmaceuticals, Inc: collaborator

Study Sites (1)

Orthopaedic Specialists of Dallas

Rockwall, Texas, 75032, United States

RECRUITING

Related Publications (3)

• MacRae F, Boissonnault E, Hashemi M, Winston P. Bilateral Suprascapular Nerve Cryoneurolysis for Pain Associated With Glenohumeral Osteoarthritis: A Case Report. Arch Rehabil Res Clin Transl. 2023 Jan 25;5(1):100256. doi: 10.1016/j.arrct.2023.100256. eCollection 2023 Mar.

  PMID: 36968166 BACKGROUND

• Best MJ, Aziz KT, Wilckens JH, McFarland EG, Srikumaran U. Increasing incidence of primary reverse and anatomic total shoulder arthroplasty in the United States. J Shoulder Elbow Surg. 2021 May;30(5):1159-1166. doi: 10.1016/j.jse.2020.08.010. Epub 2020 Aug 26.

  PMID: 32858194 BACKGROUND

• Trescot AM. Cryoanalgesia in interventional pain management. Pain Physician. 2003 Jul;6(3):345-60.

  PMID: 16880882 BACKGROUND

MeSH Terms

Conditions

Joint Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Study Officials

• Mohammad U Burney, MD

  North Texas Medical Research Institute, PLLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeff Neumann, PA-C

CONTACT

972-503-9495; jneumann@dallasortho.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization The design of this trial will utilize a 1:1 randomization schema. Randomization will be performed by an online randomization tool from the National Cancer Institute (https://ctrandomization.cancer.gov/home/). This randomization list will be kept with the study trial documents in a secured location and initially blinded from the primary research team.

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 15, 2025
• Study Start: July 30, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)