Early Percutaneous Cryoablation for Pain Control After Rib Fractures Among Elderly Patients

NCT04482582 | Completed Results FDA Device

• 1 other identifier: 57099
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to provide long-term pain control for elderly patients with rib fractures in order to minimize their risk of complications and return them to baseline functional capacity

Conditions

Rib Fractures

Keywords

rib fractures, CT guided cryoneurolysis

Outcome Measures

Primary Outcomes (1)

• Acute Pain Assessed by Numeric Pain Score

  The patient will be asked to verbalize their numeric pain score on the day of hospital discharge. Pain is measured on a scale of 0 to 10, with 0 being no pain and 10 being the worst pain. Note: The timing of hospital discharge varies by patient as these are polytrauma patients.

  Hospital discharge (up to 1 month)

Secondary Outcomes (8)

• 30-day Mortality

  1 month after hospital discharge

• Number of Participants Requiring ICU Admission

  1 month after hospital discharge

• Length of Hospital Stay

  Up to 1 month

• Use of Narcotic Equivalents

  Hospital discharge (up to 1 month), 1 month, 3 months, 12 months after hospital discharge

• Number of Participants With a Rib-specific Readmission Within 30 Days of Discharge

  1 month after hospital discharge

Study Arms (2)

Image-guided percutaneous ICN (pICN): Group A

EXPERIMENTAL

Patients who were admitted after a traumatic injury, with rib fractures identified, who are \>= 65 years of age will be randomized to percutaneous image-guided cryoneurolysis (pICN) group within 72 hours of presentation.

Radiation: Cryoneurolysis

Standard-of Care : Group B

ACTIVE COMPARATOR

Patients who were admitted after a traumatic injury, with rib fractures identified, who are \>= 65 years of age will be randomized to standard-of-care group within 72 hours of presentation.

Other: Standard of Care

Interventions

Cryoneurolysis RADIATION

Patients will be offered a minimally invasive solution known as cryoneurolysis. By directly applying a cold cryoneurolysis probe to the nerves the axon is destroyed, resulting in Wallerian degeneration of the distal nerve without distorting epineurial or perineurial tissue. Application of cryoneurolysis will help reduce the amount of narcotics the patient would need to take and instead provide them longer term pain control with minimal risk.

Image-guided percutaneous ICN (pICN): Group A

Standard of Care OTHER

Patients will be provided regular standard of care at the Stanford Hospital with long-term follow-up provided at the Stanford Center for Reconstruction after Chest Wall Injury.

Standard-of Care : Group B

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• i) Patients greater than 65 years with any acute rib fracture
• ii) Pain score equal to or greater than 5 with deep inspiration.
• iii) Presenting and admitted to Stanford Emergency Department

You may not qualify if:

• i) Radiographic evidence of metastasis to ribs
• ii) Glasgow Coma Scale (GCS) score \<13
• iii) Patients undergoing SSRF
• iv) Rib fractures located \< 3cm from spinous process
• v) Coagulopathy (INR \>1.5, Pat \< 100)
• vi) Other factors precluding cryoablation at IR attending's discretion
• vii) If only ribs broken are 1,2 or 10,11, 12

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Hospital and Clinics

Palo Alto, California, 94305, United States

Location

Related Publications (37)

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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

Limitations and Caveats

Single-center study at an ACS Level I trauma center limits generalizability. Lack of blinding and potential placebo effect introduce bias. Only patients \>65 were included, and the prone positioning introduced bias as only healthier individuals were able to tolerate positioning. CT guidance may not reflect outcomes with other modalities. Variable treatment levels, no follow-up physical exam, subjective pain measures, and use of generic (not rib-specific) PROs further limit interpretation.

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

• Nishita Kothary, 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: We are proposing a prospective, randomized trial evaluating efficacy of image-guided percutaneous intercostal cryoneurolysis (pICN) for pain control after traumatic rib fractures in persons \>=65 years. Eligible patients would be enrolled by the trauma service after consent or assent is obtained. Patients will be randomized to either pICN within 72 hours of presentation or existing standard-of-care.

Study Record Dates

• First Submitted: July 18, 2020
• First Posted: July 22, 2020
• Study Start: June 1, 2021
• Primary Completion: April 25, 2024
• Study Completion: April 30, 2025
• Last Updated: March 27, 2026
• Results First Posted: March 27, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)