Treatment of Adult Traumatic Rib Fractures With Percutaneous Cryoneurolysis

NCT05330611 | Completed Results FDA Device

• 1 other identifier: 64713
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to examine the effectiveness of using the Iovera Smart Time 190, for ultrasound-guided cryoneurolysis, in trauma patients 18-64 years old with rib fractures that are not candidates for surgical stabilization. This will offer patients the benefits of cryoneurolysis of the intercostal nerves, thereby providing short and long term pain control while their ribs heal. The Iovera Smart Tip 190 is FDA approved for cryoneurolysis.

Conditions

Rib Fractures

Keywords

Percutaneous Cryoneurolysis

Outcome Measures

Primary Outcomes (1)

• Daily Numeric Pain Score

  Patients will be asked to verbalize their numeric pain score, measured on a scale of 0 to 10, with 0 being no pain and 10 being the worst pain. Daily numeric pain score is collected on the day the patient is discharged from the hospital.

  At time of discharge from hospital (up to 1 month)

Secondary Outcomes (8)

• Daily Narcotic Equivalents

  Collected at discharge (up to 1 month), 1, 3, 12 months post discharge

• Number of Patients With 30-day Mortality

  1 month after hospital discharge

• Need for ICU Admission

  1 month after hospital discharge

• Number of Patients With a 30-day Rib-specific Admission

  1 month after hospital discharge

• The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Sub Scores

  Collected 1, 3, 12 months (post hospital discharge)

Study Arms (2)

Ultrasound-guided Cryoneurolysis: Group A

EXPERIMENTAL

Patients who are admitted to the Emergency Department after a traumatic injury. Patients will have rib fractures in any of ribs 3-9. Patients will be 18-64 years of age and will be randomized (1:1) to the ultrasound-guided cryoneurolysis group within 72 hours of admission to the ED. Intervention is ultrasound-guided cryoneurolysis of intercostal nerves creating lost lasting pain relief. Device used for cryoneurolysis is Iovera Smart tip 190

Device: Cryoneurolysis of Intercostal Nerves

Standard-of-Care : Group B

ACTIVE COMPARATOR

Patients who are admitted to the Emergency Department after a traumatic injury. Patients will have rib fractures in any of ribs 3-9. Patients will be 18-64 years of age and will be randomized (1:1) to Standard of Care which typically includes multi-modal pain therapy and pulmonary toilet.

Other: Standard of Care

Interventions

Cryoneurolysis of Intercostal Nerves DEVICE

Patients will be offered a minimally invasive intervention procedure for pain control called cryoneurolysis using an ultrasound-guided device called the Iovera Smart Tip 190. The direct application of cold to the intercostal nerves via Iovera device produces lesions in peripheral nervous tissue to block the pain caused by rib fractures. This procedure is particularly beneficial for patients who are not candidates for surgical stabilization of their rib fractures. Application of cryoneurolysis as an analgesic will reduce the amount of narcotics patients might need and instead provide them short- or long-term pain control with minimal risk. Follow up includes pain surveys administered in Chest Wall clinic or via telephone at 30, 90, 365 days post discharge.

Ultrasound-guided Cryoneurolysis: Group A

Standard of Care OTHER

Patients will be provided regular standard of care at the Stanford Hospital with short- or long-term follow-up provided at the Stanford Center for Reconstruction after Chest Wall Injury. Standard of care for patients with rib fractures that are not eligible for surgical stabilization includes multi-modal pain therapy and pulmonary toilet. Follow up includes pain surveys administered in Chest Wall clinic or via telephone at 30, 90, 365 days post discharge.

Standard-of-Care : Group B

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients 18 to 64 years with any acute rib fracture between rib 3 and rib 9
• Pain score equal to or greater than 5 with deep inspiration
• Presenting and admitted to Stanford Adult Emergency Department, having a trauma consult, and being admitted to the trauma floors of Stanford Healthcare (SHC) for their inpatient stay

You may not qualify if:

• Radiographic evidence of metastasis to ribs
• Glasgow Coma Scale (GCS) score \<13
• Patients undergoing SSRF (Surgical stabilization of rib fractures)
• Rib fractures located \< 3cm from spinous process
• Coagulopathy (INR \>1.5, Plt \< 100)
• Other factors precluding cryoneurolysis at the attending's discretion
• If only ribs broken are 1,2 or 10,11,12
• Inability to be positioned for the procedure
• If the patient has the following conditions that the manufacturer of the Iovera device advises AGAINST using the device if present: Cryoglobulinemia, Paroxysmal cold hemoglobinuria, Cold urticaria, Raynaud's disease, open and/or infected wounds at or near the treatment site.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Hospital and Clinics

Palo Alto, California, 94305, United States

Location

Related Publications (28)

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  PMID: 41604277 DERIVED

MeSH Terms

Conditions

Rib Fractures

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dr. Joseph Forrester
• Organization: Stanford University

jdf1@stanford.edu

720-284-2317

Study Officials

• Joseph D Forrester, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Ariel Knight, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Model Details: The investigators are proposing a prospective, randomized trial evaluating efficacy of ultrasound-guided cryoneurolysis for pain control after traumatic rib fractures in patients 18-64 years of age. Eligible patients would be enrolled by the trauma service after consent is obtained.

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: April 15, 2022
• Study Start: February 21, 2023
• Primary Completion: February 2, 2025
• Study Completion: February 2, 2026
• Last Updated: April 24, 2026
• Results First Posted: April 24, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)