Osteoarthritis Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who are male, or female and not currently pregnant and not planning to become pregnant during the trial
- People aged between 30 and 85 years old
- People with a body mass index (BMI) of 45 or below
- People who are already scheduled for a planned, non-emergency reverse total shoulder replacement surgery due to natural wear and tear of the shoulder joint (primary osteoarthritis)
- People who are able to give their informed agreement to take part in a clinical trial
- People who can understand and communicate in English
- People who are willing to follow all of the study's required procedures throughout the trial
Who may not be able to join:
- People with poorly managed ongoing health conditions that would make surgery unsafe, such as poorly controlled diabetes (HbA1c above 8.0), reduced kidney function (eGFR below 60), or serious heart failure classified as NYHA Class 3 or 4
- People with certain medical conditions that would prevent the treatment being used safely, including cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud's disease, or open or infected wounds at or near the treatment area (confirm with trial site)
- People who have ever had an infection in a joint replacement, or who have had any infection in the past 6 months
- People with an anaesthetic risk score (ASA) above 3, or an Outpatient Arthroplasty Risk Assessment (OARA) score above 80, which are tools doctors use to assess surgical and day-surgery risk
- People who have previously had a procedure called cryoneurolysis on the nerve near the shoulder (suprascapular nerve), or who are currently using supplemental or holistic pain management methods such as cannabidiol (CBD) — the trial team notes this would need to be stopped 30 days before surgery and not used during the study period, and this will be assessed by the research team before any agreement to participate
- People taking significant blood-thinning medications (other than aspirin) within 7 days before treatment
- People who have had heart or cardiovascular surgery within the last 6 months
- People with significant nerve or neurological conditions affecting the arm scheduled for surgery, whether acquired or present from birth, that the investigator believes could affect the study results (confirm with trial site, as the criteria appear incomplete)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Mohammad U Burney, MD, North Texas Medical Research Institute, PLLC
Phone: 972-503-9495
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
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).
Can't join this trial?
Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.