Cryoneurolysis for Rib Fractures
Phase-Based Progress Estimates
Effectiveness
Safety
Rib Fractures+1 More
Cryoneurolysis - RadiationEligibility
65+
All Sexes
What conditions do you have?
Select
Eligibility
65+
All Sexes
What conditions do you have?
Select
Study Summary
This trial is studying a long-term pain control method for elderly patients with rib fractures. The goal is to help them heal without complications and return to their normal level of function.
Eligible Conditions
- Rib Fractures
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 7 Secondary · Reporting Duration: 12 months
1 month
30-day mortality
30-day rib-specific readmission
Number of participants requiring ICU admission
12 months
Acute Pain Assessed by Numeric Pain Score
Short Form (SF-12) Health Survey Scale Score
The Glasgow Outcome Scale Extended (GOS-E) Score
The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Scale Score
Use of Narcotic Equivalents
Up to 1 month
Length of hospital stay
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Standard-of Care : Group B
1 of 2
Image-guided percutaneous ICN (pICN): Group A
1 of 2
Active Control
Experimental Treatment
110 Total Participants · 2 Treatment Groups
Primary Treatment: Cryoneurolysis · No Placebo Group · N/A
Image-guided percutaneous ICN (pICN): Group A
Radiation
Experimental Group · 1 Intervention: Cryoneurolysis · Intervention Types: RadiationStandard-of Care : Group B
Other
ActiveComparator Group · 1 Intervention: Standard of Care · Intervention Types: OtherTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cryoneurolysis
2018
N/A
~150
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,148 Previous Clinical Trials
35,678,894 Total Patients Enrolled
5 Trials studying Rib Fractures
399 Patients Enrolled for Rib Fractures
Nishita Kothary, MDPrincipal InvestigatorStanford University
1 Previous Clinical Trials
Joseph D Forrester, MDPrincipal InvestigatorStanford University
1 Previous Clinical Trials
40 Total Patients Enrolled
1 Trials studying Rib Fractures
40 Patients Enrolled for Rib Fractures
Eligibility Criteria
Age 65+ · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:Patients must have a GCS score of < 13.
The patient is unfit for cryoablation due to other factors.
You do not have any rib fractures of ribs 3,4,5,6,7,8, or 9.
Patients undergoing Surgical Stabilization of Rib Fractures (SSRF) are 18 years or older.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
References
- Flagel, Benjamin T., Fred A. Luchette, R. Lawrence Reed, Thomas J. Esposito, Kimberly A. Davis, John M. Santaniello, and Richard L. Gamelli. 2005. “Half-a-dozen Ribs: The Breakpoint for Mortality”. Surgery. Elsevier BV. doi:10.1016/j.surg.2005.07.022.
- Holcomb, John B, Neil R McMullin, Rosemary A Kozar, Marjorie H Lygas, and Frederick A Moore. 2003. “Morbidity from Rib Fractures Increases After Age 45”. Journal of the American College of Surgeons. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/s1072-7515(02)01894-x.
- Bulger, Eileen M., Matthew A. Arneson, Charles N. Mock, and Gregory J. Jurkovich. 2000. “Rib Fractures in the Elderly”. The Journal of Trauma: Injury, Infection, and Critical Care. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00005373-200006000-00007.
- Liman, S. 2003. “Chest Injury Due to Blunt Trauma”. European Journal of Cardio-thoracic Surgery. Oxford University Press (OUP). doi:10.1016/s1010-7940(02)00813-8.
- Shi, Helen H, Micaela Esquivel, Kristan L Staudenmayer, and David A Spain. 2017. “Effects of Mechanism of Injury and Patient Age on Outcomes in Geriatric Rib Fracture Patients”. Trauma Surgery & Acute Care Open. BMJ. doi:10.1136/tsaco-2016-000074.
- Ziegler, Daniel W., and Nikhileshwer N. Agarwal. 1994. “The Morbidity and Mortality of Rib Fractures”. The Journal of Trauma: Injury, Infection, and Critical Care. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00005373-199412000-00018.
- Stawicki, Stanislaw P., Michael D. Grossman, Brian A. Hoey, Donna L. Miller, and James F. Reed III. 2004. “Rib Fractures in the Elderly: A Marker of Injury Severity”. Journal of the American Geriatrics Society. Wiley. doi:10.1111/j.1532-5415.2004.52223.x.
- Van Vledder, Mark G., On behalf of the South West Netherlands Trauma Region Study Group, Vicky Kwakernaak, Tjebbe Hagenaars, Esther M. M. Van Lieshout, and Michiel H. J. Verhofstad. 2018. “Patterns of Injury and Outcomes in the Elderly Patient with Rib Fractures: A Multicenter Observational Study”. European Journal of Trauma and Emergency Surgery. Springer Science and Business Media LLC. doi:10.1007/s00068-018-0969-9.
- WILSON, J.T. LINDSAY, LAURA E.L. PETTIGREW, and GRAHAM M. TEASDALE. 1998. “Structured Interviews for the Glasgow Outcome Scale and the Extended Glasgow Outcome Scale: Guidelines for Their Use”. Journal of Neurotrauma. Mary Ann Liebert Inc. doi:10.1089/neu.1998.15.573.
- Witt, Cordelie E, and Eileen M Bulger. 2017. “Comprehensive Approach to the Management of the Patient with Multiple Rib Fractures: A Review and Introduction of a Bundled Rib Fracture Management Protocol”. Trauma Surgery & Acute Care Open. BMJ. doi:10.1136/tsaco-2016-000064.
- Todd, S. Rob, Michael M. McNally, John B. Holcomb, Rosemary A. Kozar, Lillian S. Kao, Ernest A. Gonzalez, Christine S. Cocanour, et al.. 2006. “A Multidisciplinary Clinical Pathway Decreases Rib Fracture–associated Infectious Morbidity and Mortality in High-risk Trauma Patients”. The American Journal of Surgery. Elsevier BV. doi:10.1016/j.amjsurg.2006.08.048.
- de Jong, M. B., M. C. Kokke, F. Hietbrink, and L. P. H. Leenen. 2014. “Surgical Management of Rib Fractures: Strategies and Literature Review”. Scandinavian Journal of Surgery. SAGE Publications. doi:10.1177/1457496914531928.
- Tignanelli, Christopher J., Alexander Rix, Lena M. Napolitano, Mark R. Hemmila, Sisi Ma, and Erich Kummerfeld. 2020. “Association Between Adherence to Evidence-based Practices for Treatment of Patients with Traumatic Rib Fractures and Mortality Rates Among US Trauma Centers”. JAMA Network Open. American Medical Association (AMA). doi:10.1001/jamanetworkopen.2020.1316.
- Kulminski, Alexander M., Svetlana V. Ukraintseva, Irina V. Kulminskaya, Konstantin G. Arbeev, Kenneth Land, and Anatoli I. Yashin. 2008. “Cumulative Deficits Better Characterize Susceptibility to Death in Elderly People Than Phenotypic Frailty: Lessons from the Cardiovascular Health Study”. Journal of the American Geriatrics Society. Wiley. doi:10.1111/j.1532-5415.2008.01656.x.
- Farhat, Joseph S., Vic Velanovich, Anthony J. Falvo, H. Mathilda Horst, Andrew Swartz, Joe H. Patton, and Ilan S. Rubinfeld. 2012. “Are the Frail Destined to Fail? Frailty Index as Predictor of Surgical Morbidity and Mortality in the Elderly”. Journal of Trauma and Acute Care Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/ta.0b013e3182542fab.
- van Kan, Gabor Abellan, Yves Rolland, Mathieu Houles, Sophie Gillette-Guyonnet, Maria Soto, and Bruno Vellas. 2010. “The Assessment of Frailty in Older Adults”. Clinics in Geriatric Medicine. Elsevier BV. doi:10.1016/j.cger.2010.02.002.
- Galvagno, Samuel Michael, Charles E. Smith, Albert J. Varon, Erik A. Hasenboehler, Shahnaz Sultan, Gregory Shaefer, Kathleen B. To, et al.. 2016. “Pain Management for Blunt Thoracic Trauma”. Journal of Trauma and Acute Care Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/ta.0000000000001209.
- Janssen, Ties L., Elmand Hosseinzoi, Dagmar I. Vos, Eelco J. Veen, Paul G. H. Mulder, Adrianus M. van der Holst, and Lijckle van der Laan. 2019. “The Importance of Increased Awareness for Delirium in Elderly Patients with Rib Fractures After Blunt Chest Wall Trauma: A Retrospective Cohort Study on Risk Factors and Outcomes”. BMC Emergency Medicine. Springer Science and Business Media LLC. doi:10.1186/s12873-019-0248-z.
- Gordy, Stephanie, Loic Fabricant, Bruce Ham, Richard Mullins, and John Mayberry. 2014. “The Contribution of Rib Fractures to Chronic Pain and Disability”. The American Journal of Surgery. Elsevier BV. doi:10.1016/j.amjsurg.2013.12.012.
- Koethe, Yilun, Andrew J. Mannes, and Bradford J. Wood. 2013. “Image-guided Nerve Cryoablation for Post-thoracotomy Pain Syndrome”. Cardiovascular and Interventional Radiology. Springer Science and Business Media LLC. doi:10.1007/s00270-013-0718-8.
- Pieracci, Fredric M., Kiara Leasia, Zach Bauman, Evert A. Eriksson, Lawrence Lottenberg, Sarah Majercik, Ledford Powell, et al.. 2019. “A Multicenter, Prospective, Controlled Clinical Trial of Surgical Stabilization of Rib Fractures in Patients with Severe, Nonflail Fracture Patterns (chest Wall Injury Society NONFLAIL)”. Journal of Trauma and Acute Care Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/ta.0000000000002559.
- Marasco, Silvana, Geraldine Lee, Robyn Summerhayes, Mark Fitzgerald, and Michael Bailey. 2015. “Quality of Life After Major Trauma with Multiple Rib Fractures”. Injury. Elsevier BV. doi:10.1016/j.injury.2014.06.014.
- Harbaugh, Calista M., Kevin N. Johnson, Courtney E. Kein, Marcus D. Jarboe, Ronald B. Hirschl, James D. Geiger, and Samir K. Gadepalli. 2018. “Comparing Outcomes with Thoracic Epidural and Intercostal Nerve Cryoablation After Nuss Procedure”. Journal of Surgical Research. Elsevier BV. doi:10.1016/j.jss.2018.05.048.
- Byas-Smith, Michael G., and Amitabh Gulati. 2006. “Ultrasound-guided Intercostal Nerve Cryoablation”. Anesthesia & Analgesia. Ovid Technologies (Wolters Kluwer Health). doi:10.1213/01.ane.0000237290.68166.c2.
- WARE, JOHN E., JR., MARK KOSINSKI, and SUSAN D. KELLER. 1996. “A 12-item Short-form Health Survey”. Medical Care. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00005650-199603000-00003.
- Sharma, Om P., Michael F. Oswanski, Shashank Jolly, Sherry K. Lauer, Rhonda Dressel, and Heather A. Stombaugh. 2008. “Perils of Rib Fractures”. The American Surgeon. SAGE Publications. doi:10.1177/000313480807400406.
- Fabricant, Loic, Bruce Ham, Richard Mullins, and John Mayberry. 2013. “Prolonged Pain and Disability Are Common After Rib Fractures”. The American Journal of Surgery. Elsevier BV. doi:10.1016/j.amjsurg.2012.12.007.
- Chen Zhu, Roger, Amory de Roulet, Takuya Ogami, and Konstantin Khariton. 2020. “Rib Fixation in Geriatric Trauma: Mortality Benefits for the Most Vulnerable Patients”. Journal of Trauma and Acute Care Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/ta.0000000000002666.
- Ilfeld, Brian M., Jessica Preciado, and Andrea M. Trescot. 2016. “Novel Cryoneurolysis Device for the Treatment of Sensory and Motor Peripheral Nerves”. Expert Review of Medical Devices. Informa UK Limited. doi:10.1080/17434440.2016.1204229.
- Keller, Benjamin A., Sandra K. Kabagambe, James C. Becker, Y. Julia Chen, Laura F. Goodman, Julianna M. Clark-Wronski, Kenneth Furukawa, et al.. 2016. “Intercostal Nerve Cryoablation Versus Thoracic Epidural Catheters for Postoperative Analgesia Following Pectus Excavatum Repair: Preliminary Outcomes in Twenty-six Cryoablation Patients”. Journal of Pediatric Surgery. Elsevier BV. doi:10.1016/j.jpedsurg.2016.09.034.
- Melzack, Ronald. 1975. “The Mcgill Pain Questionnaire: Major Properties and Scoring Methods”. Pain. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/0304-3959(75)90044-5.
- Pieracci, Fredric M., Sarah Majercik, Francis Ali-Osman, Darwin Ang, Andrew Doben, John G. Edwards, Bruce French, et al.. 2017. “Consensus Statement: Surgical Stabilization of Rib Fractures Rib Fracture Colloquium Clinical Practice Guidelines”. Injury. Elsevier BV. doi:10.1016/j.injury.2016.11.026.
- Rao, Raj D., Chirag A. Berry, Narayan Yoganandan, and Arnav Agarwal. 2014. “Occupant and Crash Characteristics in Thoracic and Lumbar Spine Injuries Resulting from Motor Vehicle Collisions”. The Spine Journal. Elsevier BV. doi:10.1016/j.spinee.2014.01.038.
- Ilfeld, Brian M.. 2017. “Continuous Peripheral Nerve Blocks”. Anesthesia & Analgesia. Ovid Technologies (Wolters Kluwer Health). doi:10.1213/ane.0000000000001581.
- Vossler, John D., and Frank Z. Zhao. 2019. “Intercostal Nerve Cryoablation for Control of Traumatic Rib Fracture Pain: A Case Report”. Trauma Case Reports. Elsevier BV. doi:10.1016/j.tcr.2019.100229.
- Marasco, Silvana F., Kate Martin, Louise Niggemeyer, Robyn Summerhayes, Mark Fitzgerald, and Michael Bailey. 2019. “Impact of Rib Fixation on Quality of Life After Major Trauma with Multiple Rib Fractures”. Injury. Elsevier BV. doi:10.1016/j.injury.2018.11.005.
- Witt, Cordelie E, and Eileen M Bulger. 2017. “Comprehensive Approach to the Management of the Patient with Multiple Rib Fractures: A Review and Introduction of a Bundled Rib Fracture Management Protocol”. Trauma Surgery & Acute Care Open. BMJ. doi:10.1136/tsaco-2016-000064.
- Ilfeld, Brian M., Jessica Preciado, and Andrea M. Trescot. 2016. “Novel Cryoneurolysis Device for the Treatment of Sensory and Motor Peripheral Nerves”. Expert Review of Medical Devices. Informa UK Limited. doi:10.1080/17434440.2016.1204229.
- Joseph Forrester 2021. "Early Percutaneous Cryoablation for Pain Control After Rib Fractures Among Elderly Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04482582.
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