Rib FracturesTrauma-PC2NCT05330611
Treatment of Adult Traumatic Rib Fractures With Percutaneous Cryoneurolysis
A study testing Cryoneurolysis of Intercostal Nerves in people with Rib Fractures, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Rib Fractures
- What is being tested?
- Cryoneurolysis of Intercostal Nerves
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2023to 2 Feb 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Hospital and Clinics
Palo Alto, California, 94305
About this study
Official title: Treatment of Adult Traumatic Rib Fractures With Percutaneous Cryoneurolysis for Pain Control (Trauma-PC2-study)
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.
Read the detailed description
The purpose of this research study is to examine the effectiveness of using the Iovera Smart Time 190, for minimally invasive ultrasound-guided cryoneurolysis, in trauma patients 18-64 years old with rib fractures that are not candidates for surgical stabilization. This procedure will offer patients the benefits of cryoneurolysis (freezing) of the intercostal nerves, thereby providing short and long term pain control while their ribs heal.
Patients in the intervention arm will receive cryoneurolysis via the Iovera device and patients in the control arm will receive standard of care which typically includes multimodal pain therapy and pulmonary toilet. Short and long term pain relief will be compared among both arms.
- Conditions
- Rib Fractures
- Being tested
- Cryoneurolysis of Intercostal Nerves, Standard of Care
- Keywords
- Percutaneous Cryoneurolysis
- Medical subject headings
- Rib Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryoneurolysis of Intercostal NervesDevice
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.
Standard of CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At time of discharge from hospital (up to 1 month)
Secondary outcomes (8)
Daily Narcotic Equivalents
Morphine Milligram Equivalents (MME)
Measured: Collected at discharge (up to 1 month), 1, 3, 12 months post discharge
Number of Patients With 30-day Mortality
Number of patients who died within 30 days of discharge, obtained from chart review.
Measured: 1 month after hospital discharge
Need for ICU Admission
Will be obtained from chart review after discharge
Measured: 1 month after hospital discharge
Number of Patients With a 30-day Rib-specific Admission
Patients with at least one rib-specific readmission (delayed hemothorax, pneumothorax, pneumonia, pain) within 30 days of discharge
Measured: 1 month after hospital discharge
The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Sub Scores
The McGill Pain Questionnaire (MPQ) is a validated 20 question instrument to quantify subjective pain and the scoring system yields a Pain Rating Index (PRI) score between Mild, Moderate or Severe. The questionnaire will be administered to the patient by study/clinical staff during follow up. Using these questionnaires, McGill Present Pain Intensity (PPI), Sensory, Affective, and Visual Analogue Scale (VAS) sub scores will be calculated and reported. PPI and Visual Analogue Scale scores are on a scale of 0-10, Sensory scores are on a scale of 0-33, and Affective scores are on a scale of 0-12. For all McGill pain scores, a higher score indicates a worse outcome.
Measured: Collected 1, 3, 12 months (post hospital discharge)
The Glasgow Outcome Scale Extended (GOS-E) Score
The Glasgow Outcome Scale (GOS) is a global scale for functional outcome that rates patient status into one of five categories: Dead, Vegetative State, Severe Disability, Moderate Disability or Good Recovery. The Extended GOS (GOSE) provides more detailed categorization into eight categories by subdividing the categories of severe disability, moderate disability and good recovery into a lower and upper category:
- Death (D)
- Vegetative state (VS)
- Lower severe disability (SD -)
- Upper severe disability (SD +)
- Lower moderate disability ( MD -)
- Upper moderate disability ( MD +)
- Lower good recovery (GR -)
- Upper good recovery (GR +)
The questionnaire will be administered to the patient by study/clinical staff during follow up.
Measured: Collected 1, 3, 12 months post hospital discharge
Short Form (SF-12) Health Survey Scale Summary Scores
The 12-Item Short-Form Health Survey is a widely used composite score used to gauge overall health. The composite score is based on 8 domains scores contained in the SF-12 questionnaire, which will be administered to the patient by study/clinical staff during follow up. The composite score is split into two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Both PCS and MCS are standardized scores on a 0-100 scale based on the US population, with a mean of 50 and a standard deviation of 10. Higher PCS or MCS scores indicate better health, while lower scores indicate worse health.
Measured: Collected 1, 3, 12 months (post hospital discharge)
Length of Hospital Stay
The length of hospital stay will be obtained from the patient's chart after discharge.
Measured: Up to 1 month from ED arrival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start21 Feb 2023
- Primary completion2 Feb 2025
- Study completion2 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Rib FracturesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Forrester, Stanford University
- Investigators
- Joseph D Forrester, MD, Principal investigator, Stanford UniversityAriel Knight, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330611
- Sponsor's protocol ID
- 64713
- Acronym
- Trauma-PC2
- Status last verified
- Aug 2025
- First submitted
- 11 Mar 2022
- Last updated
- 24 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Ziegler DW, Agarwal NN. The morbidity and mortality of rib fractures. J Trauma. 1994 Dec;37(6):975-9. doi: 10.1097/00005373-199412000-00018.
PubMed 7996614Flagel BT, Luchette FA, Reed RL, Esposito TJ, Davis KA, Santaniello JM, Gamelli RL. Half-a-dozen ribs: the breakpoint for mortality. Surgery. 2005 Oct;138(4):717-23; discussion 723-5. doi: 10.1016/j.surg.2005.07.022.
PubMed 16269301Sharma OP, Oswanski MF, Jolly S, Lauer SK, Dressel R, Stombaugh HA. Perils of rib fractures. Am Surg. 2008 Apr;74(4):310-4. doi: 10.1177/000313480807400406.
PubMed 18453294Marasco S, Lee G, Summerhayes R, Fitzgerald M, Bailey M. Quality of life after major trauma with multiple rib fractures. Injury. 2015 Jan;46(1):61-5. doi: 10.1016/j.injury.2014.06.014. Epub 2014 Jun 21.
PubMed 25069400Fabricant L, Ham B, Mullins R, Mayberry J. Prolonged pain and disability are common after rib fractures. Am J Surg. 2013 May;205(5):511-5; discusssion 515-6. doi: 10.1016/j.amjsurg.2012.12.007.
PubMed 23592156Gordy S, Fabricant L, Ham B, Mullins R, Mayberry J. The contribution of rib fractures to chronic pain and disability. Am J Surg. 2014 May;207(5):659-62; discussion 662-3. doi: 10.1016/j.amjsurg.2013.12.012. Epub 2014 Jan 31.
PubMed 24612969Liman ST, Kuzucu A, Tastepe AI, Ulasan GN, Topcu S. Chest injury due to blunt trauma. Eur J Cardiothorac Surg. 2003 Mar;23(3):374-8. doi: 10.1016/s1010-7940(02)00813-8.
PubMed 12614809Witt CE, Bulger EM. Comprehensive approach to the management of the patient with multiple rib fractures: a review and introduction of a bundled rib fracture management protocol. Trauma Surg Acute Care Open. 2017 Jan 5;2(1):e000064. doi: 10.1136/tsaco-2016-000064. eCollection 2017.
PubMed 29766081Todd SR, McNally MM, Holcomb JB, Kozar RA, Kao LS, Gonzalez EA, Cocanour CS, Vercruysse GA, Lygas MH, Brasseaux BK, Moore FA. A multidisciplinary clinical pathway decreases rib fracture-associated infectious morbidity and mortality in high-risk trauma patients. Am J Surg. 2006 Dec;192(6):806-11. doi: 10.1016/j.amjsurg.2006.08.048.
PubMed 17161098de Jong MB, Kokke MC, Hietbrink F, Leenen LP. Surgical Management of Rib Fractures: Strategies and Literature Review. Scand J Surg. 2014 Jun;103(2):120-125. doi: 10.1177/1457496914531928. Epub 2014 Apr 29.
PubMed 24782038Shi HH, Esquivel M, Staudenmayer KL, Spain DA. Effects of mechanism of injury and patient age on outcomes in geriatric rib fracture patients. Trauma Surg Acute Care Open. 2017 Mar 16;2(1):e000074. doi: 10.1136/tsaco-2016-000074. eCollection 2017.
PubMed 29766084Tignanelli CJ, Rix A, Napolitano LM, Hemmila MR, Ma S, Kummerfeld E. Association Between Adherence to Evidence-Based Practices for Treatment of Patients With Traumatic Rib Fractures and Mortality Rates Among US Trauma Centers. JAMA Netw Open. 2020 Mar 2;3(3):e201316. doi: 10.1001/jamanetworkopen.2020.1316.
PubMed 32215632Pieracci FM, Majercik S, Ali-Osman F, Ang D, Doben A, Edwards JG, French B, Gasparri M, Marasco S, Minshall C, Sarani B, Tisol W, VanBoerum DH, White TW. Consensus statement: Surgical stabilization of rib fractures rib fracture colloquium clinical practice guidelines. Injury. 2017 Feb;48(2):307-321. doi: 10.1016/j.injury.2016.11.026. Epub 2016 Nov 27. No abstract available.
PubMed 27912931Chen Zhu R, de Roulet A, Ogami T, Khariton K. Rib fixation in geriatric trauma: Mortality benefits for the most vulnerable patients. J Trauma Acute Care Surg. 2020 Jul;89(1):103-110. doi: 10.1097/TA.0000000000002666.
PubMed 32176172Ryb GE, Dischinger PC, Burch CA, Kerns TJ, Kufera J, Andersen D. Frailty and injury causation. Ann Adv Automot Med. 2012;56:175-81.
PubMed 23169127
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Adult Traumatic Rib Fractures With Percutaneous Cryoneurolysis for Pain Control (Trauma-PC2-study)
- ClinicalTrials.gov ID
- NCT05330611
- Acronym / sponsor ID
- Trauma-PC2 / 64713
- Conditions
- Rib Fractures
- Keywords
- Percutaneous Cryoneurolysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 2 Feb 2025 (actual)
- Study completion
- 2 Feb 2026 (actual)
- First posted
- 15 Apr 2022 (actual)
- Results
- Posted 24 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this research study is to examine the effectiveness of using the Iovera Smart Time 190, for minimally invasive ultrasound-guided cryoneurolysis, in trauma patients 18-64 years old with rib fractures that are not candidates for surgical stabilization. This procedure will offer patients the benefits of cryoneurolysis (freezing) of the intercostal nerves, thereby providing short and long term pain control while their ribs heal.
Patients in the intervention arm will receive cryoneurolysis via the Iovera device and patients in the control arm will receive standard of care which typically includes multimodal pain therapy and pulmonary toilet. Short and long term pain relief will be compared among both arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided Cryoneurolysis: Group A | Experimental | Device: Cryoneurolysis of Intercostal NervesPatients 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 |
| Standard-of-Care : Group B | Active comparator | Other: Standard of CarePatients 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryoneurolysis of Intercostal NervesPatients 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. | Device | Ultrasound-guided Cryoneurolysis: Group A |
| Standard of CarePatients 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. | Other | Standard-of-Care : Group B |
Primary outcome
Daily Numeric Pain Score
Time frame: At time of discharge from hospital (up to 1 month)
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.
8 secondary outcomes
Daily Narcotic Equivalents
Time frame: Collected at discharge (up to 1 month), 1, 3, 12 months post discharge
Number of Patients With 30-day Mortality
Time frame: 1 month after hospital discharge
Need for ICU Admission
Time frame: 1 month after hospital discharge
Number of Patients With a 30-day Rib-specific Admission
Time frame: 1 month after hospital discharge
The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Sub Scores
Time frame: Collected 1, 3, 12 months (post hospital discharge)
The Glasgow Outcome Scale Extended (GOS-E) Score
Time frame: Collected 1, 3, 12 months post hospital discharge
Short Form (SF-12) Health Survey Scale Summary Scores
Time frame: Collected 1, 3, 12 months (post hospital discharge)
Length of Hospital Stay
Time frame: Up to 1 month from ED arrival
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 7996614Ziegler DW, Agarwal NN. The morbidity and mortality of rib fractures. J Trauma. 1994 Dec;37(6):975-9. doi: 10.1097/00005373-199412000-00018.
- Background: PubMed 16269301Flagel BT, Luchette FA, Reed RL, Esposito TJ, Davis KA, Santaniello JM, Gamelli RL. Half-a-dozen ribs: the breakpoint for mortality. Surgery. 2005 Oct;138(4):717-23; discussion 723-5. doi: 10.1016/j.surg.2005.07.022.
- Background: PubMed 18453294Sharma OP, Oswanski MF, Jolly S, Lauer SK, Dressel R, Stombaugh HA. Perils of rib fractures. Am Surg. 2008 Apr;74(4):310-4. doi: 10.1177/000313480807400406.
- Background: PubMed 25069400Marasco S, Lee G, Summerhayes R, Fitzgerald M, Bailey M. Quality of life after major trauma with multiple rib fractures. Injury. 2015 Jan;46(1):61-5. doi: 10.1016/j.injury.2014.06.014. Epub 2014 Jun 21.
- Background: PubMed 23592156Fabricant L, Ham B, Mullins R, Mayberry J. Prolonged pain and disability are common after rib fractures. Am J Surg. 2013 May;205(5):511-5; discusssion 515-6. doi: 10.1016/j.amjsurg.2012.12.007.
- Background: PubMed 24612969Gordy S, Fabricant L, Ham B, Mullins R, Mayberry J. The contribution of rib fractures to chronic pain and disability. Am J Surg. 2014 May;207(5):659-62; discussion 662-3. doi: 10.1016/j.amjsurg.2013.12.012. Epub 2014 Jan 31.
- Background: PubMed 12614809Liman ST, Kuzucu A, Tastepe AI, Ulasan GN, Topcu S. Chest injury due to blunt trauma. Eur J Cardiothorac Surg. 2003 Mar;23(3):374-8. doi: 10.1016/s1010-7940(02)00813-8.
- Background: PubMed 29766081Witt CE, Bulger EM. Comprehensive approach to the management of the patient with multiple rib fractures: a review and introduction of a bundled rib fracture management protocol. Trauma Surg Acute Care Open. 2017 Jan 5;2(1):e000064. doi: 10.1136/tsaco-2016-000064. eCollection 2017.
- Background: PubMed 17161098Todd SR, McNally MM, Holcomb JB, Kozar RA, Kao LS, Gonzalez EA, Cocanour CS, Vercruysse GA, Lygas MH, Brasseaux BK, Moore FA. A multidisciplinary clinical pathway decreases rib fracture-associated infectious morbidity and mortality in high-risk trauma patients. Am J Surg. 2006 Dec;192(6):806-11. doi: 10.1016/j.amjsurg.2006.08.048.
- Background: PubMed 24782038de Jong MB, Kokke MC, Hietbrink F, Leenen LP. Surgical Management of Rib Fractures: Strategies and Literature Review. Scand J Surg. 2014 Jun;103(2):120-125. doi: 10.1177/1457496914531928. Epub 2014 Apr 29.
- Background: PubMed 29766084Shi HH, Esquivel M, Staudenmayer KL, Spain DA. Effects of mechanism of injury and patient age on outcomes in geriatric rib fracture patients. Trauma Surg Acute Care Open. 2017 Mar 16;2(1):e000074. doi: 10.1136/tsaco-2016-000074. eCollection 2017.
- Background: PubMed 32215632Tignanelli CJ, Rix A, Napolitano LM, Hemmila MR, Ma S, Kummerfeld E. Association Between Adherence to Evidence-Based Practices for Treatment of Patients With Traumatic Rib Fractures and Mortality Rates Among US Trauma Centers. JAMA Netw Open. 2020 Mar 2;3(3):e201316. doi: 10.1001/jamanetworkopen.2020.1316.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph D Forrester, MD principal investigator
Stanford University
Ariel Knight, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoneurolysis of Intercostal Nerves in people with Rib Fractures, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Numeric Pain Score (time frame: At time of discharge from hospital (up to 1 month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05330611, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.