Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-31 @ 12:38 PM
Study NCT ID:
NCT07125833
Status:
RECRUITING
Last Update Posted:
2025-08-15
First Post:
2025-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cryoneurolysis of the Suprascapular Nerve for Perioperative Pain Control After Receiving a Reverse Total Shoulder Arthroplasty (RTSA)
Sponsor:
North Texas Medical Research Institute, PLLC
Organization:
Study Overview
Official Title:
A Randomized Pilot Trial for Cryoneurolysis of the Suprascapular Nerve for Perioperative Pain Control After Receiving a Reverse Total Shoulder Arthroplasty
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
Detailed 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?
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?
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: