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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
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. In order to do this, we would offer a minimally invasive solution known as Cryoneurolysis. By directly applying cold Cryoneurolysis to the nerves, this can destroy nerve axons, resulting in Wallerian degeneration of the distal nerve without distorting epineural or perineurial tissue. The application of cryoneurolysis will help reduce the amount of narcotics the patient would need, and potentially lead to a better post-injury quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day Mortality | Will be obtained from chart review after discharge | 1 month after hospital discharge |
| Number of Participants Requiring ICU Admission | Will be obtained from chart review after discharge |
Not provided
Inclusion criteria:
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
Exclusion criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Joseph D Forrester, MD | Stanford University | Principal Investigator |
| Nishita Kothary, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Hospital and Clinics | Palo Alto | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7996614 | Background | 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. | |
| 16269301 | Background | Flagel 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. |
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Patients were pre-screened to determine if they met eligibility criteria. If this was met, they were approached by a CRC for in-person consent at Stanford Healthcare (SHC). The enrollment period was from June 1, 2021, to April 15, 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Image-guided Percutaneous ICN (pICN): Group A | 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. |
| FG001 | Standard-of Care : Group B | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
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| |||||||||||||||||||||
| 1-month follow-up |
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| 3-month follow-up |
| ||||||||||||||||||||||
| 12-month follow-up |
|
Includes 7 screen failures that were considered ITT. This change was made in October 2023 and is reflected in the protocol.
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| ID | Title | Description |
|---|---|---|
| BG000 | Image-guided Percutaneous ICN (pICN): Group A | 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. |
| BG001 | Standard-of Care : Group B |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Includes 7 ITT patients per September 2023 protocol amendment | Posted | Mean | Standard Deviation | score on a scale | Hospital discharge (up to 1 month) |
|
From enrollment to one year post-discharge from hospital
Prospective and retrospective analysis
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Image-guided Percutaneous ICN (pICN): Group A | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rib specific readmission | Musculoskeletal and connective tissue disorders | Systematic Assessment | Chest wall specific readmission. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Small hematoma at cryoprobe insertion site. No intervention performed or needed to address |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joseph Forrester | Stanford University | 720-284-2317 | jdf1@stanford.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 27, 2023 | Feb 13, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 28, 2023 | Mar 5, 2026 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D012253 | Rib Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D013898 | Thoracic Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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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.
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|
| 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. |
|
| 1 month after hospital discharge |
| Length of Hospital Stay | The Length of Stay will be obtained from the patient's chart after discharge and will depend on the level of care required for recovery from their injuries. | Up to 1 month |
| Use of Narcotic Equivalents | Daily oral 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 | The patient will be admitted back to the hospital if pain level relates to rib-specific injuries such as hemothorax and pneumonia. | 1 month after hospital discharge |
| The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Scale Score | 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 at 1-month, 3-month, and 12-month follow-ups. Using the questionnaires, McGill Present Pain Intensity (PPI), Sensory, Affective, and Visual Analogue Scale 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. Higher scores indicate worse pain for all McGill scores. | 1 month, 3 months, 12 months (all from 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:
The questionnaire will be administered to the patient by study/clinical staff upon discharge. | 1 month, 3 months, 12 months (all from hospital discharge) |
| Short Form (SF-12) Health Survey Scale Score | 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 upon discharge. The composite score is split into two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Both scores are on a scale of 0-100, with higher scores representing better mental health-related (MCS) or physical health-related (PCS) quality of life. The means of both scores are standardized to 50 with a standard devation of 10. | 1 month, 3 months, 12 months (all from hospital discharge) |
| 18453294 | Background | Sharma 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. |
| 25069400 | Background | Marasco 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. |
| 23592156 | Background | Fabricant 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. |
| 24612969 | Background | Gordy 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. |
| 12691929 | Background | Holcomb JB, McMullin NR, Kozar RA, Lygas MH, Moore FA. Morbidity from rib fractures increases after age 45. J Am Coll Surg. 2003 Apr;196(4):549-55. doi: 10.1016/S1072-7515(02)01894-X. |
| 15086666 | Background | Stawicki SP, Grossman MD, Hoey BA, Miller DL, Reed JF 3rd. Rib fractures in the elderly: a marker of injury severity. J Am Geriatr Soc. 2004 May;52(5):805-8. doi: 10.1111/j.1532-5415.2004.52223.x. |
| 10866248 | Background | Bulger EM, Arneson MA, Mock CN, Jurkovich GJ. Rib fractures in the elderly. J Trauma. 2000 Jun;48(6):1040-6; discussion 1046-7. doi: 10.1097/00005373-200006000-00007. |
| 12614809 | Background | Liman 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. |
| 29905897 | Background | Van Vledder MG, Kwakernaak V, Hagenaars T, Van Lieshout EMM, Verhofstad MHJ; South West Netherlands Trauma Region Study Group. Patterns of injury and outcomes in the elderly patient with rib fractures: a multicenter observational study. Eur J Trauma Emerg Surg. 2019 Aug;45(4):575-583. doi: 10.1007/s00068-018-0969-9. Epub 2018 Jun 15. |
| 29766081 | Background | Witt 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. |
| 17161098 | Background | Todd 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. |
| 24782038 | Background | de 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. |
| 29766084 | Background | Shi 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. |
| 32215632 | Background | Tignanelli 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. |
| 27912931 | Background | Pieracci 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. |
| 32176172 | Background | Chen 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. |
| 18363679 | Background | Kulminski AM, Ukraintseva SV, Kulminskaya IV, Arbeev KG, Land K, Yashin AI. Cumulative deficits better characterize susceptibility to death in elderly people than phenotypic frailty: lessons from the Cardiovascular Health Study. J Am Geriatr Soc. 2008 May;56(5):898-903. doi: 10.1111/j.1532-5415.2008.01656.x. Epub 2008 Mar 21. |
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| 23169127 | Background | Ryb GE, Dischinger PC, Burch CA, Kerns TJ, Kufera J, Andersen D. Frailty and injury causation. Ann Adv Automot Med. 2012;56:175-81. |
| 27533913 | Background | Galvagno SM Jr, Smith CE, Varon AJ, Hasenboehler EA, Sultan S, Shaefer G, To KB, Fox AD, Alley DE, Ditillo M, Joseph BA, Robinson BR, Haut ER. Pain management for blunt thoracic trauma: A joint practice management guideline from the Eastern Association for the Surgery of Trauma and Trauma Anesthesiology Society. J Trauma Acute Care Surg. 2016 Nov;81(5):936-951. doi: 10.1097/TA.0000000000001209. |
| 27749354 | Background | Ilfeld BM. Continuous Peripheral Nerve Blocks: An Update of the Published Evidence and Comparison With Novel, Alternative Analgesic Modalities. Anesth Analg. 2017 Jan;124(1):308-335. doi: 10.1213/ANE.0000000000001581. |
| 31195982 | Background | Janssen TL, Hosseinzoi E, Vos DI, Veen EJ, Mulder PGH, van der Holst AM, van der Laan L. 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 Emerg Med. 2019 Jun 13;19(1):34. doi: 10.1186/s12873-019-0248-z. |
| 27333989 | Background | Ilfeld BM, Preciado J, Trescot AM. Novel cryoneurolysis device for the treatment of sensory and motor peripheral nerves. Expert Rev Med Devices. 2016 Aug;13(8):713-25. doi: 10.1080/17434440.2016.1204229. Epub 2016 Jul 13. |
| 27745867 | Background | Keller BA, Kabagambe SK, Becker JC, Chen YJ, Goodman LF, Clark-Wronski JM, Furukawa K, Stark RA, Rahm AL, Hirose S, Raff GW. Intercostal nerve cryoablation versus thoracic epidural catheters for postoperative analgesia following pectus excavatum repair: Preliminary outcomes in twenty-six cryoablation patients. J Pediatr Surg. 2016 Dec;51(12):2033-2038. doi: 10.1016/j.jpedsurg.2016.09.034. Epub 2016 Sep 28. |
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| 31388539 | Background | Vossler JD, Zhao FZ. Intercostal nerve cryoablation for control of traumatic rib fracture pain: A case report. Trauma Case Rep. 2019 Jul 31;23:100229. doi: 10.1016/j.tcr.2019.100229. eCollection 2019 Oct. |
| 23954965 | Background | Koethe Y, Mannes AJ, Wood BJ. Image-guided nerve cryoablation for post-thoracotomy pain syndrome. Cardiovasc Intervent Radiol. 2014 Jun;37(3):843-6. doi: 10.1007/s00270-013-0718-8. Epub 2013 Aug 17. |
| 17000825 | Background | Byas-Smith MG, Gulati A. Ultrasound-guided intercostal nerve cryoablation. Anesth Analg. 2006 Oct;103(4):1033-5. doi: 10.1213/01.ane.0000237290.68166.c2. |
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| 1235985 | Background | Melzack R. The McGill Pain Questionnaire: major properties and scoring methods. Pain. 1975 Sep;1(3):277-299. doi: 10.1016/0304-3959(75)90044-5. |
| 30442372 | Background | Marasco SF, Martin K, Niggemeyer L, Summerhayes R, Fitzgerald M, Bailey M. Impact of rib fixation on quality of life after major trauma with multiple rib fractures. Injury. 2019 Jan;50(1):119-124. doi: 10.1016/j.injury.2018.11.005. Epub 2018 Nov 3. |
| 9726257 | Background | Wilson JT, Pettigrew LE, Teasdale GM. Structured interviews for the Glasgow Outcome Scale and the extended Glasgow Outcome Scale: guidelines for their use. J Neurotrauma. 1998 Aug;15(8):573-85. doi: 10.1089/neu.1998.15.573. |
| 8628042 | Background | Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003. |
| 41700907 | Derived | Forrester JD, Abreo A, Earley M, King JM, Kesselman A, Vezeridis AM, Picel AC, Kothary N. Early Percutaneous Cryoneurolysis for Pain Control After Rib Fracture for Older Patients: A Prospective Randomized Clinical Trial. J Am Coll Surg. 2026 Jul 1;243(1):36-46. doi: 10.1097/XCS.0000000000001856. Epub 2026 Mar 4. |
| 36385136 | Derived | Liou RJ, Earley MJ, Forrester JD. Effect of climate on surgical site infections and anticipated increases in the United States. Sci Rep. 2022 Nov 16;12(1):19698. doi: 10.1038/s41598-022-24255-w. |
| Dropped by Investigator |
|
| Protocol Violation |
|
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Highest pain score in first 24 hours | Baseline pain on a scale of 0 (no pain) to 10 (maximum pain) | Mean | Standard Deviation | points |
|
| Daily opioid equivalents in first 24 hours | Measured in morphine milligram equivalents (MMEs), standardized to 24 hours | Median | Inter-Quartile Range | MMEs |
|
| Standard-of Care : Group B |
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. |
|
|
|
| Secondary | 30-day Mortality | Will be obtained from chart review after discharge | This analysis population includes patients with available data. | Posted | Count of Participants | Participants | 1 month after hospital discharge |
|
|
|
|
| Secondary | Number of Participants Requiring ICU Admission | Will be obtained from chart review after discharge | Includes 7 ITT patients | Posted | Count of Participants | Participants | 1 month after hospital discharge |
|
|
|
|
| Secondary | Length of Hospital Stay | The Length of Stay will be obtained from the patient's chart after discharge and will depend on the level of care required for recovery from their injuries. | Includes 7 ITT patients | Posted | Median | Inter-Quartile Range | days | Up to 1 month |
|
|
|
|
| Secondary | Use of Narcotic Equivalents | Daily oral narcotic equivalents | Includes 7 ITT patients | Posted | Median | Inter-Quartile Range | MME/day | Hospital discharge (up to 1 month), 1 month, 3 months, 12 months after hospital discharge |
|
|
|
|
| Secondary | Number of Participants With a Rib-specific Readmission Within 30 Days of Discharge | The patient will be admitted back to the hospital if pain level relates to rib-specific injuries such as hemothorax and pneumonia. | Participants with available data were included in this analysis. | Posted | Count of Participants | Participants | 1 month after hospital discharge |
|
|
|
|
| Secondary | The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Scale Score | 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 at 1-month, 3-month, and 12-month follow-ups. Using the questionnaires, McGill Present Pain Intensity (PPI), Sensory, Affective, and Visual Analogue Scale 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. Higher scores indicate worse pain for all McGill scores. | The analysis population includes everyone who has at least 1 McGill score reported at any follow-up timepoint. | Posted | Mean | Standard Deviation | scores on a scale | 1 month, 3 months, 12 months (all from hospital discharge) |
|
|
|
|
| Secondary | 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:
The questionnaire will be administered to the patient by study/clinical staff upon discharge. | Participants who had GOS-E data at any follow-up time point are included. | Posted | Count of Participants | Participants | 1 month, 3 months, 12 months (all from hospital discharge) |
|
|
|
|
| Secondary | Short Form (SF-12) Health Survey Scale Score | 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 upon discharge. The composite score is split into two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Both scores are on a scale of 0-100, with higher scores representing better mental health-related (MCS) or physical health-related (PCS) quality of life. The means of both scores are standardized to 50 with a standard devation of 10. | Participants with available SF-12 scores at any follow-up time point were included. | Posted | Median | Inter-Quartile Range | score on a scale | 1 month, 3 months, 12 months (all from hospital discharge) |
|
|
|
|
| 3 |
| 56 |
| 13 |
| 56 |
| 9 |
| 56 |
| EG001 | Standard-of Care : Group B | 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. | 3 | 54 | 11 | 54 | 24 | 54 |
|
| Non chest wall related readmission | General disorders | Systematic Assessment | All composite non-chest wall related readmissions |
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| hemopneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Both intervention patients who had a hemopneumothorax in the intervention arm had pre-existing hemopneumothoraces that worsened over time, ultimately requiring chest tube drainage. No evidence of worsening attributable to cryoneurolysis procedure. |
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| Pulmonary contusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Small pulmonary contusion adjacent to cryoneurolysis site not requiring further intervention |
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| bradycardia/tachycardia/atrial fibrillation/hypotension/code blue/aortic stenosis | Cardiac disorders | Systematic Assessment | Cardiac events listed above varied in severity and were assessed during hospitalization, at scheduled follow-up time points, and through systematic chart review as part of regular adverse event monitoring conducted by the PI and study team. |
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| Infection | Infections and infestations | Systematic Assessment | Urinary Tract Infection |
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| Constipation/vomiting | Gastrointestinal disorders | Systematic Assessment | Mild Gastrointestinal Issues (constipation/vomiting) |
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| Composite mild neurological events | Nervous system disorders | Systematic Assessment | delirium/altered mental state/mild brain infarction |
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Not provided
Not provided
| 1-month follow-up |
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| 3-month follow-up |
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| 12-month follow-up |
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| 0.014 |
Statistical significance threshold was 0.05. |
| Superiority |
| MMEs at 3-month follow-up | Wilcoxon (Mann-Whitney) | 0.199 | The statistical significance level is 0.05. | Superiority |
| MMEs at 12-month follow-up | Wilcoxon (Mann-Whitney) | 0.365 | The statistical significance level is 0.05. | Superiority |
| Sensory at 1-month follow-up (0-33) |
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| Affective at 1-month follow-up |
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| Visual Analogue Scale at 1-month follow-up |
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| PPI at 3-month follow-up |
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| Sensory at 3-month follow-up |
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| Affective at 3-month follow-up |
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| Visual Analogue Scale at 3-month follow-up |
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| PPI at 12-month follow-up |
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| Sensory at 12-month follow-up |
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| Affective at 12-month follow-up |
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| Visual Analogue Scale at 12-month follow-up |
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| t-test, 2 sided |
Satterthwaite t-test |
| <0.001 |
The two-sided statistical significance level was 0.05. |
| Superiority |
| McGill Affective at 1-month follow-up | Wilcoxon (Mann-Whitney) | 0.011 | The statistical significance level was 0.05. | Superiority |
| McGill PPI at 3-month follow-up | t-test, 2 sided | Pooled t-test | 0.153 | The two-sided statistical significance level was 0.05. | Superiority |
| McGill Sensory at 3-month follow-up | t-test, 2 sided | Pooled t-test | 0.322 | The two-sided statistical significance level was 0.05. | Superiority |
| McGill Affective at 3-month follow-up | Wilcoxon (Mann-Whitney) | 0.695 | The statistical significance level was 0.05. | Superiority |
| McGill PPI at 12-month follow-up | t-test, 2 sided | Pooled t-test | 0.866 | The statistical significance level was 0.05. | Superiority |
| McGill Sensory at 12-month follow-up | t-test, 2 sided | Pooled t-test | 0.684 | The statistical significance level was 0.05. | Superiority |
| McGill Affective at 12-month follow-up. | Wilcoxon (Mann-Whitney) | All scores were 0. | >0.99 | The statistical significance level was 0.05. | Superiority |
| This analysis determined if McGill PPI scores decreased from discharge to 1-month follow-up among intervention participants. | Wilcoxon (signed-rank) | This analysis only included the 39 intervention participants who had available PPI scores at discharge and 1-month follow-up. | <.001 | The statistical significance level was 0.05. | Other | Groups were not being compared here. |
| This analysis assessed whether McGill PPI scores decreased from 1-month to 3-month follow-up among intervention participants. | Wilcoxon signed-rank | This analysis only included the 24 intervention patients who had available PPI scores at 1-month and 3-month follow-ups. | 0.013 | The statistical significance level was 0.05. | Other | This test did not compare between groups. |
| This analysis assessed whether McGill PPI scores significantly decreased from 3-month follow-up to 12-month follow-up among intervention participants. | Wilcoxon (signed-rank) | This analysis only included the 25 intervention patients who had available PPI scores at both 3-month and 12-month follow-ups. | <0.001 | The statistical significance level was 0.05. | Other | Groups were not compared here. |
| The model assessed differential change in pain score over time. It included pain scores reported at baseline and discharge, as well as PPI scores reported at all three follow-ups. | Mixed Models Analysis | 0.432 | The two-sided statistical significance level was 0.05. The reported p-value was for the interaction between time and treatment group. The model was a random intercept and slope (RIAS) model. | Superiority |
| SD+ |
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| MD- |
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| MD+ |
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| GR- |
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| GR+ |
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| 3-month follow-up |
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| 12-month follow-up |
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| 0.068 |
The statistical significance level was 0.05. |
| Superiority |
| GOS-E at 12-month follow-up | Freeman-Halton | 0.466 | The statistical significance level was 0.05. | Superiority |
| SF-12 MCS score at 1-month follow-up |
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| SF-12 PCS at 3-month follow-up |
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| SF-12 MCS score at 3-month follow-up |
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| SF-12 PCS at 12-month follow-up |
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| SF-12 MCS at 12-month follow-up |
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| Wilcoxon (Mann-Whitney) |
| 0.722 |
The statistical significance level was 0.05. |
| Superiority |
| SF-12 PCS at 3-month follow-up | Wilcoxon (Mann-Whitney) | 0.355 | The statistical significance level was 0.05. | Superiority |
| SF-12 MCS at 3-month follow-up | Wilcoxon (Mann-Whitney) | 0.381 | The statistical significance level was 0.05. | Superiority |
| SF-12 PCS at 12-month follow-up | Wilcoxon (Mann-Whitney) | 0.328 | The statistical significance level was 0.05. | Superiority |
| SF-12 MCS score at 12-month follow-up | Wilcoxon (Mann-Whitney) | 0.070 | The statistical significance level was 0.05. | Superiority |