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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| Johns Hopkins All Children's Hospital | OTHER |
| Arkansas Children's Hospital Research Institute | OTHER |
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The purpose of this study is to determine whether a posterior fossa decompression or a posterior fossa decompression with duraplasty results in better patient outcomes with fewer complications and improved quality of life in those who have Chiari malformation type I and syringomyelia.
Participants with Chiari Malformation type I and syringomyelia will be randomized to either have a posterior fossa decompression done with or without duraplasty. The participant will then return to the neurosurgeon's office at the following time points which are consistent with standard of care practice: < 6 weeks, 3-6 months, and 12 months. At these visits, the clinician will complete a physical exam and the participant will report on the prognosis of symptoms and complete two quality of life questionnaires. A brain and cervical spine MRI will be performed 12 months after the decompression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Posterior fossa decompression surgery | Experimental | The bone is surgically removed from the suboccipital region of the skull and Cervical 1 lamina so the constricting epidural band can be resected |
|
| Dural augmentation surgery | Experimental | The bone is removed from the suboccipital region of the skull and Cervical 1 lamina so the constricting epidural band can be resected. Then, the dura is opened. Microsurgical dissection is performed and the dura is sewn closed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Posterior fossa decompression | Procedure | Planned areas of bone removal from the suboccipital region of the skull and cervical l1 lamina. Then, the constricting epidural band at the level of the foramen magnum is resected. |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants With Surgical Complications | The number of participants with complications such as: Cerebrospinal fluid (CSF)-related complications ≤6 months (e.g. CSF leak, pseudomeningocele, aseptic meningitis, infection, hydrocephalus), and the requirement for additional surgery for wound revision or CSF diversion | less then or equal to 6 months from decompression |
| Measure | Description | Time Frame |
|---|---|---|
| Aim 2: The Number of Patients With Clinical Improvement | Number of patients who experienced improvement in clinical or neurological symptoms-such as; headaches, pain, numbness or tingling, nausea/ vomiting, itching, weakness, difficulty swallowing, difficulty sleeping and cranial nerve assessments. | 10-14 months |
| Measure | Description | Time Frame |
|---|---|---|
| Aim 3 : Mean Change in Quality of Life Measurement After Surgery Relative to Baseline. | Quality of Life (QOL) was assessed using the Chiari Health Index Pediatrics (CHIP), and the Health Utilities-3 (HUI-3). The CHIP is a 5-point response scale. Within the physical symptoms' domain, 5 questions regarding pain severity are alternatively scaled. The Health Utilities Index Mark 3 (HUI3) is a generic status classification system, generalizable in pediatric patients with illness. The HUI3 assesses domains including vision, hearing, speech, ambulation, dexterity, emotion, cognition, and pain. We used a non-inferiority approach in the analysis. The score is corrected for missing values and scaled to a range of scores between 0 and 1. An increasing score represents increasing HRQOL. Increase/decrease in the quality of life metric (on a scale from 0-1, with 0 representing no quality of life and 1 representing 100% quality of life). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David D Limbrick, MD, PhD | Washington University-St. Louis Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Louis Children's Hospital | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16288188 | Background | Di Lorenzo N, Cacciola F. Adult syringomielia. Classification, pathogenesis and therapeutic approaches. J Neurosurg Sci. 2005 Sep;49(3):65-72. | |
| 10507374 | Background | Heiss JD, Patronas N, DeVroom HL, Shawker T, Ennis R, Kammerer W, Eidsath A, Talbot T, Morris J, Eskioglu E, Oldfield EH. Elucidating the pathophysiology of syringomyelia. J Neurosurg. 1999 Oct;91(4):553-62. doi: 10.3171/jns.1999.91.4.0553. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Posterior Fossa Decompression Surgery | The bone is surgically removed from the suboccipital region of the skull and Cervical 1 lamina so the constricting epidural band can be resected Posterior fossa decompression: Planned areas of bone removal from the suboccipital region of the skull and cervical l1 lamina. Then, the constricting epidural band at the level of the foramen magnum is resected. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
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 | Mar 1, 2021 | Oct 6, 2021 |
Not provided
| Boston Children's Hospital |
| OTHER |
| Children's Healthcare of Atlanta | OTHER |
| Dartmouth-Hitchcock Medical Center | OTHER |
| Children's Hospital Colorado | OTHER |
| Birmingham Children's Hospital | OTHER |
| Morgan Stanley Children's Hospital | OTHER |
| Phoenix Children's Hospital | OTHER |
| Children's Hospital and Health System Foundation, Wisconsin | OTHER |
| Children's National Research Institute | OTHER |
| Children's Hospital of Philadelphia | OTHER |
| Children's Hospital Medical Center, Cincinnati | OTHER |
| Columbia University | OTHER |
| Gillette Children's Specialty Healthcare | OTHER |
| Levine Children's Hospital | OTHER |
| Children's Hospital Los Angeles | OTHER |
| Ann & Robert H Lurie Children's Hospital of Chicago | OTHER |
| Mayo Clinic | OTHER |
| Nicklaus Children's Hospital f/k/a Miami Children's Hospital | OTHER |
| Medical University of South Carolina Shawn Jenkins Children's Hospital | OTHER |
| Oregon Health and Science University | OTHER |
| Penn State University | OTHER |
| University of Pittsburgh | OTHER |
| Primary Children's Hospital | OTHER |
| Seattle Children's Hospital | OTHER |
| Stanford University | OTHER |
| Baylor College of Medicine | OTHER |
| The Children's Hospital at OU Medical Center | OTHER |
| Nationwide Children's Hospital | OTHER |
| University of California | OTHER |
| University of Iowa | OTHER |
| University of Michigan | OTHER |
| The University of Texas Health Science Center, Houston | OTHER |
| University of Minnesota | OTHER |
| University of Vermont | OTHER |
| UVA Children's Hospital | OTHER |
| University of Wisconsin, Madison | OTHER |
| Vanderbilt University | OTHER |
| Wake Forest University | OTHER |
| Yale University | OTHER |
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|
| Dural Augmentation | Procedure | The dura is opened sharply, exposing the cerebellar tonsils, brainstem, and upper spinal cord. After microsurgical dissection, the dura is sewn closed with a dural graft. |
|
| Aim 2: The Mean Number of Syrinx Reduction in Millimeters Less Than 24 Months Post Surgery. |
Syrinx regression comparison between posterior fossa decompression surgery and dural augmentation surgery cohorts based on ITT. |
| 10-14 months |
| 10-14 Months from Decompression |
| 8614541 | Background | Small JA, Sheridan PH. Research priorities for syringomyelia: a National Institute of Neurological Disorders and Stroke workshop summary. Neurology. 1996 Feb;46(2):577-82. doi: 10.1212/wnl.46.2.577. No abstract available. |
| 16549414 | Background | Brickell KL, Anderson NE, Charleston AJ, Hope JK, Bok AP, Barber PA. Ethnic differences in syringomyelia in New Zealand. J Neurol Neurosurg Psychiatry. 2006 Aug;77(8):989-91. doi: 10.1136/jnnp.2005.081240. Epub 2006 Mar 20. |
| 25479580 | Background | Arnautovic A, Splavski B, Boop FA, Arnautovic KI. Pediatric and adult Chiari malformation Type I surgical series 1965-2013: a review of demographics, operative treatment, and outcomes. J Neurosurg Pediatr. 2015 Feb;15(2):161-77. doi: 10.3171/2014.10.PEDS14295. Epub 2014 Dec 5. |
| 20018097 | Background | Fernandez AA, Guerrero AI, Martinez MI, Vazquez ME, Fernandez JB, Chesa i Octavio E, Labrado Jde L, Silva ME, de Araoz MF, Garcia-Ramos R, Ribes MG, Gomez C, Valdivia JI, Valbuena RN, Ramon JR. Malformations of the craniocervical junction (Chiari type I and syringomyelia: classification, diagnosis and treatment). BMC Musculoskelet Disord. 2009 Dec 17;10 Suppl 1(Suppl 1):S1. doi: 10.1186/1471-2474-10-S1-S1. |
| 10199291 | Background | Hida K, Iwasaki Y, Koyanagi I, Abe H. Pediatric syringomyelia with chiari malformation: its clinical characteristics and surgical outcomes. Surg Neurol. 1999 Apr;51(4):383-90; discussion 390-1. doi: 10.1016/s0090-3019(98)00088-3. |
| 15715455 | Background | Mueller D, Oro' JJ. Prospective analysis of self-perceived quality of life before and after posterior fossa decompression in 112 patients with Chiari malformation with or without syringomyelia. Neurosurg Focus. 2005 Feb 15;18(2):ECP2. doi: 10.3171/foc.2005.18.2.11. |
| 19519678 | Background | Tisell M, Wallskog J, Linde M. Long-term outcome after surgery for Chiari I malformation. Acta Neurol Scand. 2009 Nov;120(5):295-9. doi: 10.1111/j.1600-0404.2009.01183.x. Epub 2009 Jun 11. |
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| 21591857 | Background | Vakharia VN, Guilfoyle MR, Laing RJ. Prospective study of outcome of foramen magnum decompressions in patients with syrinx and non-syrinx associated Chiari malformations. Br J Neurosurg. 2012 Feb;26(1):7-11. doi: 10.3109/02688697.2011.578771. Epub 2011 May 18. |
| 10834643 | Background | Munshi I, Frim D, Stine-Reyes R, Weir BK, Hekmatpanah J, Brown F. Effects of posterior fossa decompression with and without duraplasty on Chiari malformation-associated hydromyelia. Neurosurgery. 2000 Jun;46(6):1384-9; discussion 1389-90. doi: 10.1097/00006123-200006000-00018. |
| 12607030 | Background | Ventureyra EC, Aziz HA, Vassilyadi M. The role of cine flow MRI in children with Chiari I malformation. Childs Nerv Syst. 2003 Feb;19(2):109-13. doi: 10.1007/s00381-002-0701-1. Epub 2003 Jan 30. |
| 15022006 | Background | Navarro R, Olavarria G, Seshadri R, Gonzales-Portillo G, McLone DG, Tomita T. Surgical results of posterior fossa decompression for patients with Chiari I malformation. Childs Nerv Syst. 2004 May;20(5):349-56. doi: 10.1007/s00381-003-0883-1. Epub 2004 Mar 12. |
| 15835106 | Background | Limonadi FM, Selden NR. Dura-splitting decompression of the craniocervical junction: reduced operative time, hospital stay, and cost with equivalent early outcome. J Neurosurg. 2004 Nov;101(2 Suppl):184-8. doi: 10.3171/ped.2004.101.2.0184. |
| 16871867 | Background | Yeh DD, Koch B, Crone KR. Intraoperative ultrasonography used to determine the extent of surgery necessary during posterior fossa decompression in children with Chiari malformation type I. J Neurosurg. 2006 Jul;105(1 Suppl):26-32. doi: 10.3171/ped.2006.105.1.26. |
| 17252266 | Background | Galarza M, Sood S, Ham S. Relevance of surgical strategies for the management of pediatric Chiari type I malformation. Childs Nerv Syst. 2007 Jun;23(6):691-6. doi: 10.1007/s00381-007-0297-6. Epub 2007 Jan 25. |
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| 23426152 | Background | Litvack ZN, Lindsay RA, Selden NR. Dura splitting decompression for Chiari I malformation in pediatric patients: clinical outcomes, healthcare costs, and resource utilization. Neurosurgery. 2013 Jun;72(6):922-8; discussion 928-9. doi: 10.1227/NEU.0b013e31828ca1ed. |
| 24777296 | Background | Lee A, Yarbrough CK, Greenberg JK, Barber J, Limbrick DD, Smyth MD. Comparison of posterior fossa decompression with or without duraplasty in children with Type I Chiari malformation. Childs Nerv Syst. 2014 Aug;30(8):1419-24. doi: 10.1007/s00381-014-2424-5. Epub 2014 Apr 29. |
| 22044364 | Background | Rocque BG, George TM, Kestle J, Iskandar BJ. Treatment practices for Chiari malformation type I with syringomyelia: results of a survey of the American Society of Pediatric Neurosurgeons. J Neurosurg Pediatr. 2011 Nov;8(5):430-7. doi: 10.3171/2011.8.PEDS10427. |
| 16381204 | Background | Batzdorf U. Primary spinal syringomyelia. Invited submission from the joint section meeting on disorders of the spine and peripheral nerves, March 2005. J Neurosurg Spine. 2005 Dec;3(6):429-35. doi: 10.3171/spi.2005.3.6.0429. |
| 17639419 | Background | Tubbs RS, Lyerly MJ, Loukas M, Shoja MM, Oakes WJ. The pediatric Chiari I malformation: a review. Childs Nerv Syst. 2007 Nov;23(11):1239-50. doi: 10.1007/s00381-007-0428-0. Epub 2007 Jul 18. |
| Background | Wellons JC & Smyth MD (2013) Neurosurgical Face Off: Durotomy and Duraplasty Versus No Durotomy and Duraplasty. Annual Scientific Meeting of the American Association of Neurological Surgeons. |
| 25380104 | Background | Greenberg JK, Milner E, Yarbrough CK, Lipsey K, Piccirillo JF, Smyth MD, Park TS, Limbrick DD Jr. Outcome methods used in clinical studies of Chiari malformation Type I: a systematic review. J Neurosurg. 2015 Feb;122(2):262-72. doi: 10.3171/2014.9.JNS14406. Epub 2014 Nov 7. |
| 18590394 | Background | Durham SR, Fjeld-Olenec K. Comparison of posterior fossa decompression with and without duraplasty for the surgical treatment of Chiari malformation Type I in pediatric patients: a meta-analysis. J Neurosurg Pediatr. 2008 Jul;2(1):42-9. doi: 10.3171/PED/2008/2/7/042. |
| 26431245 | Background | Ladner TR, Westrick AC, Wellons JC 3rd, Shannon CN. Health-related quality of life in pediatric Chiari Type I malformation: the Chiari Health Index for Pediatrics. J Neurosurg Pediatr. 2016 Jan;17(1):76-85. doi: 10.3171/2015.5.PEDS1513. Epub 2015 Oct 2. |
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| Background | Carmines EG & Zeller RA (1979) Reliability and Validity Assessment. Quatitative Applications in the Social Sciences. (Sage Publications, Newbury Park, CA). |
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| 17119141 | Background | Weinstein JN, Lurie JD, Tosteson TD, Skinner JS, Hanscom B, Tosteson AN, Herkowitz H, Fischgrund J, Cammisa FP, Albert T, Deyo RA. Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT) observational cohort. JAMA. 2006 Nov 22;296(20):2451-9. doi: 10.1001/jama.296.20.2451. |
| 22725268 | Background | Drake JM, Singhal A, Kulkarni AV, DeVeber G, Cochrane DD; Canadian Pediatric Neurosurgery Study Group. Consensus definitions of complications for accurate recording and comparisons of surgical outcomes in pediatric neurosurgery. J Neurosurg Pediatr. 2012 Aug;10(2):89-95. doi: 10.3171/2012.3.PEDS11233. Epub 2012 Jun 22. |
| Background | Donner A & Klar N (2000) Design and Analysis of Cluster Randomization Trials in Health Research (Arnold; Oxford University Press, New York). |
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| Background | Buck SF (1960) A method of estimation of missing values in multivariate data suitable for use with an electronic computer. J Roy Statist Soc 22:302-306. |
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| Background | Greenberg JK, et al. (2014) Population-Based Analysis of Complications Associated with Chiari Malformation Type 1 Surgery in Children. AANS/CNS Joint Section on Pediatric Neurosurgery. |
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| 20890606 | Background | Hankinson T, Tubbs RS, Wellons JC. Duraplasty or not? An evidence-based review of the pediatric Chiari I malformation. Childs Nerv Syst. 2011 Jan;27(1):35-40. doi: 10.1007/s00381-010-1295-7. Epub 2010 Oct 2. |
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| 42202320 | Derived | Limbrick DD Jr, Shannon CN, Bayman EO, Meehan T, Kallem M, Ackerman LL, Adelson PD, Ahmed R, Albert G, Aldana PR, Alden TD, Anderson RCE, Baird LC, Bauer D, Bethel-Anderson T, Bierbrauer K, Brockmeyer DL, Chern JJ, Couture DE, Daniels DJ, Dauser RC, Dlouhy BJ, Durham SR, Ellenbogen RG, Eskandari R, Gannon SR, Grant GA, Graupman PC, Greenberg JK, Greene S, Greenfield JP, Gross NL, Guillaume DJ, Hankinson TC, Heuer G, Iantosca M, Iskandar BJ, Jackson EM, Jallo GI, Johnston JM, Keating RF, Kelly MP, Kennedy E, Krieger MD, Kulkarni AV, Labuda R, Leonard JR, Maher CO, Mangano FT, McComb JG, McEvoy SD, McKinstry RC, Menezes AH, Niazi TN, Oakes J, Olavarria G, O'Neill BR, Poppe D, Ragheb J, Reeves S, Reynolds L, Selden NR, Shah MN, Shimony JS, Smyth MD, Spears S, Stone SSD, Strahle JM, Tamber M, Tramelli G, Tuite GF, Tyler-Kabara EC, Vance H, Wait SD, Wellons JC 3rd, Whitehead WE, Yahanda AT, Yan Y, Dacey RG Jr, Park TS, Torner JC; Park-Reeves Syringomyelia Research Consortium Investigators. Decompression with or without Duraplasty for Chiari I and Syringomyelia. N Engl J Med. 2026 May 28;394(20):2015-2025. doi: 10.1056/NEJMoa2402821. |
| 32114543 | Derived | Hale AT, Adelson PD, Albert GW, Aldana PR, Alden TD, Anderson RCE, Bauer DF, Bonfield CM, Brockmeyer DL, Chern JJ, Couture DE, Daniels DJ, Durham SR, Ellenbogen RG, Eskandari R, George TM, Grant GA, Graupman PC, Greene S, Greenfield JP, Gross NL, Guillaume DJ, Heuer GG, Iantosca M, Iskandar BJ, Jackson EM, Johnston JM, Keating RF, Leonard JR, Maher CO, Mangano FT, McComb JG, Meehan T, Menezes AH, O'Neill B, Olavarria G, Park TS, Ragheb J, Selden NR, Shah MN, Smyth MD, Stone SSD, Strahle JM, Wait SD, Wellons JC, Whitehead WE, Shannon CN, Limbrick DD; Park-Reeves Syringomyelia Research Consortium Investigators. Factors associated with syrinx size in pediatric patients treated for Chiari malformation type I and syringomyelia: a study from the Park-Reeves Syringomyelia Research Consortium. J Neurosurg Pediatr. 2020 Mar 6;25(6):629-639. doi: 10.3171/2020.1.PEDS19493. Print 2020 Jun 1. |
| FG001 | Dural Augmentation Surgery | The bone is removed from the suboccipital region of the skull and Cervical 1 lamina so the constricting epidural band can be resected. Then, the dura is opened. Microsurgical dissection is performed and the dura is sewn closed. Dural Augmentation: The dura is opened sharply, exposing the cerebellar tonsils, brainstem, and upper spinal cord. After microsurgical dissection, the dura is sewn closed with a dural graft. |
|
| 3-6 Month Follow up |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Posterior Fossa Decompression Surgery | The bone is surgically removed from the suboccipital region of the skull and Cervical 1 lamina so the constricting epidural band can be resected Posterior fossa decompression: Planned areas of bone removal from the suboccipital region of the skull and cervical l1 lamina. Then, the constricting epidural band at the level of the foramen magnum is resected. |
| BG001 | Dural Augmentation Surgery | The bone is removed from the suboccipital region of the skull and Cervical 1 lamina so the constricting epidural band can be resected. Then, the dura is opened. Microsurgical dissection is performed and the dura is sewn closed. Dural Augmentation: The dura is opened sharply, exposing the cerebellar tonsils, brainstem, and upper spinal cord. After microsurgical dissection, the dura is sewn closed with a dural graft. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Note: values represent reporting by ITT, i.e. split by randomization, not necessarily treatment received | Mean | Standard Deviation | years |
| ||||||||||||||||
| Sex: Female, Male | Note: values represent reporting by ITT, i.e. split by randomization, not necesarily treatment received | Count of Participants | Participants |
| |||||||||||||||||
| Ethnicity (NIH/OMB) | Note: values represent reporting by ITT, i.e. split by randomization, not necessarily treatment received | Count of Participants | Participants |
| |||||||||||||||||
| Race (NIH/OMB) | Note: values represent reporting by ITT, i.e. split by randomization, not necesarily treatment received | Count of Participants | Participants |
| |||||||||||||||||
| Size of Syringomyelia | Note: values represent reporting by ITT, i.e. split by randomization, not necessarily treatment received | Count of Participants | Participants |
|
| 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 | The Number of Participants With Surgical Complications | The number of participants with complications such as: Cerebrospinal fluid (CSF)-related complications ≤6 months (e.g. CSF leak, pseudomeningocele, aseptic meningitis, infection, hydrocephalus), and the requirement for additional surgery for wound revision or CSF diversion | Note: values represent reporting by ITT, i.e. split by randomization, not necessarily treatment received. | Posted | Count of Participants | Participants | less then or equal to 6 months from decompression |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Aim 2: The Number of Patients With Clinical Improvement | Number of patients who experienced improvement in clinical or neurological symptoms-such as; headaches, pain, numbness or tingling, nausea/ vomiting, itching, weakness, difficulty swallowing, difficulty sleeping and cranial nerve assessments. | Note: values represent reporting by ITT, i.e. split by randomization, not necessarily treatment received | Posted | Count of Participants | Participants | 10-14 months |
| |||||||||||||||||||||||||||||||
| Secondary | Aim 2: The Mean Number of Syrinx Reduction in Millimeters Less Than 24 Months Post Surgery. | Syrinx regression comparison between posterior fossa decompression surgery and dural augmentation surgery cohorts based on ITT. | Values represent reporting by ITT not treatment received | Posted | Mean | Standard Deviation | millimeters | 10-14 months |
| ||||||||||||||||||||||||||||||
| Other Pre-specified | Aim 3 : Mean Change in Quality of Life Measurement After Surgery Relative to Baseline. | Quality of Life (QOL) was assessed using the Chiari Health Index Pediatrics (CHIP), and the Health Utilities-3 (HUI-3). The CHIP is a 5-point response scale. Within the physical symptoms' domain, 5 questions regarding pain severity are alternatively scaled. The Health Utilities Index Mark 3 (HUI3) is a generic status classification system, generalizable in pediatric patients with illness. The HUI3 assesses domains including vision, hearing, speech, ambulation, dexterity, emotion, cognition, and pain. We used a non-inferiority approach in the analysis. The score is corrected for missing values and scaled to a range of scores between 0 and 1. An increasing score represents increasing HRQOL. Increase/decrease in the quality of life metric (on a scale from 0-1, with 0 representing no quality of life and 1 representing 100% quality of life). | Note: values represent reporting by ITT, i.e. split by randomization, not necessarily treatment received | Posted | Mean | Standard Deviation | score on a scale | 10-14 Months from Decompression |
|
< 6 weeks, 3-6 months and 10-14 months
Patients were followed by their physician at <6 weeks, 3-6 months and 10-14 months or as needed per standard clinical care. If individuals experienced adverse events they would have been reported during those interactions.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Posterior Fossa Decompression Surgery | The bone is surgically removed from the suboccipital region of the skull and Cervical 1 lamina so the constricting epidural band can be resected Posterior fossa decompression: Planned areas of bone removal from the suboccipital region of the skull and cervical l1 lamina. Then, the constricting epidural band at the level of the foramen magnum is resected. | 0 | 84 | 0 | 84 | 0 | 84 |
| EG001 | Dural Augmentation Surgery | The bone is removed from the suboccipital region of the skull and Cervical 1 lamina so the constricting epidural band can be resected. Then, the dura is opened. Microsurgical dissection is performed and the dura is sewn closed. Dural Augmentation: The dura is opened sharply, exposing the cerebellar tonsils, brainstem, and upper spinal cord. After microsurgical dissection, the dura is sewn closed with a dural graft. | 0 | 78 | 0 | 78 | 0 | 78 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David D. Limbrick MD | Washington University | 314-454-3212 | T.Meehan@wustl.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 22, 2021 | Oct 7, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001139 | Arnold-Chiari Malformation |
| D013595 | Syringomyelia |
| ID | Term |
|---|---|
| D009436 | Neural Tube Defects |
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Syrinx AP Diameter (mm) 7-9 mm |
|
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| Participants |
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| Units |
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| Counts |
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| Participants |
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| Dural Augmentation Surgery |
The bone is removed from the suboccipital region of the skull and Cervical 1 lamina so the constricting epidural band can be resected. Then, the dura is opened. Microsurgical dissection is performed and the dura is sewn closed. Dural Augmentation: The dura is opened sharply, exposing the cerebellar tonsils, brainstem, and upper spinal cord. After microsurgical dissection, the dura is sewn closed with a dural graft. |
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