Recruiting

Cryoneurolysis

Sponsor:

North Texas Medical Research Institute, PLLC

Code:

NCT07125833

Conditions

Degenerative Joint Disease of Shoulder

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Cryoneurolysis

No cryoneurolysis

Study Details

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

Study ID

NCT07125833

Start date

Jul 30, 2025

Status verified date

Aug, 2025

Completion date

Aug, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Control

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

experimental: Intervention

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

Interventions

Cryoneurolysis

Cryoneurolysis of the suprascapular nerve

No cryoneurolysis

Control Group

Primary outcome measure

  • 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). [ Time Frame: 90 days ]

Central Contacts and Locations

Central contacts

Jeff Neumann, PA-C

972-503-9495jneumann@dallasortho.net

Locations

Orthopaedic Specialists of Dallas

Recruiting

Rockwall, Texas, United States, 75032

Contacts

Jeffery Neumann, PA-C

972-503-9495jneumann@dallasortho.net

Principal Investigator:

Mohammad U Burney, MD

More Information

Sponsor

North Texas Medical Research Institute, PLLC

Last update posted

Aug 15, 2025

Last verified

Aug, 2025

Keywords

  • cryoneurolysis
  • degenerative joint disease
  • reverse shoulder arthroplasty

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by North Texas Medical Research Institute, PLLC on 2025-08-15.