Randomized Control Trial, Cryoablation as an Adjunct to Surgical Stabilization of Rib Fractures

March 12, 2026 updated by: Wake Forest University Health Sciences

Single Center, Randomized Control Trial of Cryoablation During Surgical Stabilization of Rib Fractures

To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of Surgical Stabilization of Rib Fractures (SSRF) without cryoablation

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Locoregional pain control with cryoneurolysis of intercostal nerves has been employed as an adjunct for longer term pain control. Initially introduced in thoracic surgery, intercostal nerve cryoablation has demonstrated adequate pain control and substantial decrease in opioid consumption and hospital length of stay.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University Health Sciences
        • Contact:

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The patient is admitted to the trauma service.
  • The patient has multiple displaced rib fractures (≥2 ribs), offered fixation, and consents to SSRF
  • The patient is not being treated for chronic pain
  • The patient is >18 years of age.
  • Surgery anticipated <120 hours from injury

Exclusion Criteria:

  • Age < 18 years or ≥ 80 years
  • Flail chest: either radiographic or clinical. Radiographic flail chest is defined on CT chest as ≥ 2 ribs each fractured in ≥ 2 places. Clinical flail is defined as visualization of a segment of chest wall with paradoxical motion on physical exam.
  • Moderate or severe traumatic brain injury (Intra-cranial hemorrhage visualized on CT head with GCS at the time of consideration for enrollment < 12)
  • Prior or expected emergency exploratory laparotomy during this admission
  • Prior or expected emergency thoracotomy during this admission
  • Prior or expected emergency craniotomy during this admission
  • Spinal cord injury
  • Pelvic fracture that has required, or is expected to require, operative intervention during this admission
  • The patient was unable to accomplish activities of daily living independently prior to injury (e.g., dressing, bathing, preparing meals)
  • The patient is incarcerated
  • The patient is known to be pregnant
  • Unable to perform Video Assisted Thoracoscopy (VATS) at time of SSRF due to lung isolation or previous pathology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Surgical Stabilization of Rib Fractures plus Multimodal Pain Therapy plus CRYOABLATION
Adding Cryoablation of levels 3-8, in addition to patients that undergo SSRF for multiple rib fractures.
Device: Cryoablation of Intercostal Nerves
Using Atricure device, cryoice, intercostal nerves 3-8 will be ablated in the experimental arm. This is in addition to mechanical fixation of rib fractures and multimodal systemic therapy.
Active Comparator: Surgical Stabilization of Rib Fractures plus Multimodal Pain Therapy
Standard surgical treatment of patients with multiple rib fractures plus Multimodal Pain Therapy
Procedure: Standard surgical treatment of patients with multiple rib fractures
Standard surgical treatment of patients with multiple rib fractures

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Morphine Milligram Equivalents Use following Intervention
Time Frame: Baseline
To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.
Baseline
Morphine Milligram Equivalents Use following Intervention
Time Frame: Day 1
To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.
Day 1
Morphine Milligram Equivalents Use following Intervention
Time Frame: Day 30
To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.
Day 30
Morphine Milligram Equivalents Use following Intervention
Time Frame: Day 90
To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.
Day 90

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of days in Hospital Stay
Time Frame: Days during admission
Hospital Length of Stay
Days during admission
Number of days in ICU Stay
Time Frame: Day 90
ICU Length of Stay
Day 90
Amount of Chest tube drainage
Time Frame: Day 90
Chest tube drainage
Day 90
Quality of Life Scores
Time Frame: Month 1 and Month 3
Quality of Life questionnaire - Quality of life questionnaire consists of a set of survey questions that can be used to collect data related to an individual in particular and society in general on various parameters that determine their general quality of life
Month 1 and Month 3
Number of Mortalities in hospital
Time Frame: Day 90
Mortality, in hospital
Day 90
Number of Readmissions
Time Frame: 30 day readmission rate
Readmission
30 day readmission rate
Number of Additional Thoracic Procedures
Time Frame: Day 7
Additional Thoracic Procedures
Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bradely W. Thomas, MD, Wake Forest University Health Sciences

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 13, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00084611

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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