RECRUITING

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

Talk to us

Conditions

Degenerative Joint Disease of Shouldercryoneurolysisdegenerative joint diseasereverse shoulder arthroplasty

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Randomized Pilot Trial for Cryoneurolysis of the Suprascapular Nerve for Perioperative Pain Control After Receiving a Reverse Total Shoulder Arthroplasty

Quick Facts

Study Start:2025-07-30
Study Completion:2026-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07125833

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male patients or female who are not pregnant and do not plan on future pregnancy during trial participation
  2. * between 30-85 years of age
  3. * BMI less than or equal to 45
  4. * Currently setup for an elective primary reverse total shoulder arthroplasty due to primary osteoarthritis
  5. * Ability to provide informed consent to participate in the clinical trial
  6. * Ability to understand and communicate in English
  7. * Willingness to comply with all study procedures
  1. * 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
  2. * inability to receive the intervention including contraindications:
  3. * Cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud's disease, and open and/or infected wounds at or near the treatment site
  4. * patients with history of total joint infection ever or any infection in the last 6 months
  5. * ASA score \>3 and Outpatient Arthroplasty Risk Assessment (OARA; medical risk stratification scoring system to help determine day surgery vs inpatient)1 score \> 80.
  6. * 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.
  7. * significant anti-coagulation usage (other than aspirin) 7 days prior to treatment
  8. * CV surgery within the last 6 months
  9. * 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

Contacts and Locations

Study Contact

Jeff Neumann, PA-C
CONTACT
972-503-9495
jneumann@dallasortho.net

Principal Investigator

Mohammad U Burney, MD
PRINCIPAL_INVESTIGATOR
North Texas Medical Research Institute, PLLC

Study Locations (Sites)

Orthopaedic Specialists of Dallas
Rockwall, Texas, 75032
United States

Collaborators and Investigators

Sponsor: North Texas Medical Research Institute, PLLC

  • Mohammad U Burney, MD, PRINCIPAL_INVESTIGATOR, North Texas Medical Research Institute, PLLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-30
Study Completion Date2026-08

Study Record Updates

Study Start Date2025-07-30
Study Completion Date2026-08

Terms related to this study

Keywords Provided by Researchers

  • cryoneurolysis
  • degenerative joint disease
  • reverse shoulder arthroplasty

Additional Relevant MeSH Terms

  • Degenerative Joint Disease of Shoulder