Arnold-Chiari Malformation, Type 1NCT02669836
Posterior Fossa Decompression With or Without Duraplasty for Chiari Type I Malformation With Syringomyelia
A study testing Posterior fossa decompression and Dural Augmentation in people with Arnold-Chiari Malformation, Type 1 and Chiari Malformation Type I, run by Washington University School of Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Arnold-Chiari Malformation, Type 1, Chiari Malformation Type I, Type I Arnold-Chiari Malformation
- What is being tested?
- Posterior fossa decompression and Dural Augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 31 Jul 2020
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age ≤21 years old
- Chiari malformation type I ≥5 mm tonsillar ectopia
- Syrinx between 3 mm and 6 mm
- Chiari Severity Index (CSI) classification 1
- MRI of the brain and cervical and thoracic spine are required prior to surgery and must be available to be shared with the Data Coordinating Center
Who cannot join
- CSI-2 or CSI-3 classification
- Syrinx <3 mm and/or ≥6 mm
- Neuro-imaging demonstrating basilar invagination
- Clival canal angle <120° (signs of severe craniovertebral junction disease)
- Chiari Malformation I + syringomyelia secondary to other pathology (e.g. a tumor)
- Unable to share pre-decompression MRI of the brain and cervical and thoracic spine
- Patients who do not wish to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Louis Children's Hospital
St Louis, Missouri, 63110
About this study
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.
Read the detailed description
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.
- Conditions
- Arnold-Chiari Malformation, Type 1, Chiari Malformation Type I, Type I Arnold-Chiari Malformation, Syringomyelia
- Being tested
- Posterior fossa decompression, Dural Augmentation
- Medical subject headings
- Arnold-Chiari Malformation, Syringomyelia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior fossa decompressionProcedure or surgery
Also called Bone only posterior decompression, Extradural posterior 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.
Dural AugmentationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Posterior fossa decompression |
| 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. Receives: Procedure: Dural Augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: less then or equal to 6 months from decompression
Secondary outcomes (2)
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.
Measured: 10-14 months
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.
Measured: 10-14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study startApr 2016
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
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 (45)Papers the sponsor has linked to this study.
- Other trials for Arnold-Chiari Malformation, Type 1Studies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Johns Hopkins All Children's Hospital, Arkansas Children's Hospital Research Institute, Boston Children's Hospital, Children's Healthcare of Atlanta, Dartmouth-Hitchcock Medical Center, Children's Hospital Colorado, Birmingham Children's Hospital, Morgan Stanley Children's Hospital, Phoenix Children's Hospital, Children's Hospital and Health System Foundation, Wisconsin, Children's National Research Institute, Children's Hospital of Philadelphia, Children's Hospital Medical Center, Cincinnati, Columbia University, Gillette Children's Specialty Healthcare, Levine Children's Hospital, Children's Hospital Los Angeles, Ann & Robert H Lurie Children's Hospital of Chicago, Mayo Clinic, Nicklaus Children's Hospital f/k/a Miami Children's Hospital, Medical University of South Carolina Shawn Jenkins Children's Hospital, Oregon Health and Science University, Penn State University, University of Pittsburgh, Primary Children's Hospital, Seattle Children's Hospital, Stanford University, Baylor College of Medicine, The Children's Hospital at OU Medical Center, Nationwide Children's Hospital, University of California, University of Iowa, University of Michigan, The University of Texas Health Science Center, Houston, University of Minnesota, University of Vermont, UVA Children's Hospital, University of Wisconsin, Madison, Vanderbilt University, Wake Forest University, Yale University
- Responsible party
- Sponsor
- Investigators
- David D Limbrick, MD, PhD, Principal investigator, Washington University-St. Louis Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02669836
- Sponsor's protocol ID
- PCORI275- 201604044
- Status last verified
- Aug 2024
- First submitted
- 13 Jan 2016
- Last updated
- 31 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Di Lorenzo N, Cacciola F. Adult syringomielia. Classification, pathogenesis and therapeutic approaches. J Neurosurg Sci. 2005 Sep;49(3):65-72.
PubMed 16288188Heiss 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.
PubMed 10507374Small 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.
PubMed 8614541Brickell 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.
PubMed 16549414Arnautovic 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.
PubMed 25479580Fernandez 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.
PubMed 20018097Hida 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.
PubMed 10199291Mueller 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.
PubMed 15715455Tisell 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.
PubMed 19519678Greenberg JK, Yarbrough CK, Radmanesh A, Godzik J, Yu M, Jeffe DB, Smyth MD, Park TS, Piccirillo JF, Limbrick DD. The Chiari Severity Index: a preoperative grading system for Chiari malformation type 1. Neurosurgery. 2015 Mar;76(3):279-85; discussion 285. doi: 10.1227/NEU.0000000000000608.
PubMed 25584956Vakharia 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.
PubMed 21591857Munshi 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.
PubMed 10834643Ventureyra 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.
PubMed 12607030Navarro 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.
PubMed 15022006Limonadi 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.
PubMed 15835106
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterior Fossa Decompression With or Without Duraplasty for Chiari Type I Malformation With Syringomyelia
- ClinicalTrials.gov ID
- NCT02669836
- Acronym / sponsor ID
- PCORI275- 201604044
- Conditions
- Arnold-Chiari Malformation, Type 1, Chiari Malformation Type I, Type I Arnold-Chiari Malformation, Syringomyelia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Johns Hopkins All Children's Hospital, Arkansas Children's Hospital Research Institute, Boston Children's Hospital, Children's Healthcare of Atlanta, Dartmouth-Hitchcock Medical Center, Children's Hospital Colorado, Birmingham Children's Hospital, Morgan Stanley Children's Hospital, Phoenix Children's Hospital, Children's Hospital and Health System Foundation, Wisconsin, Children's National Research Institute, Children's Hospital of Philadelphia, Children's Hospital Medical Center, Cincinnati, Columbia University, Gillette Children's Specialty Healthcare, Levine Children's Hospital, Children's Hospital Los Angeles, Ann & Robert H Lurie Children's Hospital of Chicago, Mayo Clinic, Nicklaus Children's Hospital f/k/a Miami Children's Hospital, Medical University of South Carolina Shawn Jenkins Children's Hospital, Oregon Health and Science University, Penn State University, University of Pittsburgh, Primary Children's Hospital, Seattle Children's Hospital, Stanford University, Baylor College of Medicine, The Children's Hospital at OU Medical Center, Nationwide Children's Hospital, University of California, University of Iowa, University of Michigan, The University of Texas Health Science Center, Houston, University of Minnesota, University of Vermont, UVA Children's Hospital, University of Wisconsin, Madison, Vanderbilt University, Wake Forest University, Yale University
- Study start
- Apr 2016 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 1 Feb 2016 (estimated)
- Results
- Posted 31 Oct 2024
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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Posterior fossa decompression surgery | Experimental | Procedure: Posterior fossa decompressionThe 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 | Procedure: Dural AugmentationThe 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. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age ≤21 years old
- Chiari malformation type I ≥5 mm tonsillar ectopia
- Syrinx between 3 mm and 6 mm
- Chiari Severity Index (CSI) classification 1
- MRI of the brain and cervical and thoracic spine are required prior to surgery and must be available to be shared with the Data Coordinating Center
Key exclusion criteria (7 listed)
- CSI-2 or CSI-3 classification
- Syrinx <3 mm and/or ≥6 mm
- Neuro-imaging demonstrating basilar invagination
- Clival canal angle <120° (signs of severe craniovertebral junction disease)
- Chiari Malformation I + syringomyelia secondary to other pathology (e.g. a tumor)
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 |
|---|---|---|
| Posterior fossa decompressionAlso: Bone only posterior decompression, Extradural posterior decompressionPlanned 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. | Procedure or surgery | Posterior fossa decompression surgery |
| Dural AugmentationThe 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. | Procedure or surgery | Dural augmentation surgery |
Primary outcome
The Number of Participants With Surgical Complications
Time frame: less then or equal to 6 months from decompression
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
2 secondary outcomes
Aim 2: The Number of Patients With Clinical Improvement
Time frame: 10-14 months
Aim 2: The Mean Number of Syrinx Reduction in Millimeters Less Than 24 Months Post Surgery.
Time frame: 10-14 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16288188Di Lorenzo N, Cacciola F. Adult syringomielia. Classification, pathogenesis and therapeutic approaches. J Neurosurg Sci. 2005 Sep;49(3):65-72.
- Background: PubMed 10507374Heiss 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.
- Background: PubMed 8614541Small 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.
- Background: PubMed 16549414Brickell 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.
- Background: PubMed 25479580Arnautovic 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.
- Background: PubMed 20018097Fernandez 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.
- Background: PubMed 10199291Hida 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.
- Background: PubMed 15715455Mueller 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.
- Background: PubMed 19519678Tisell 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.
- Background: PubMed 25584956Greenberg JK, Yarbrough CK, Radmanesh A, Godzik J, Yu M, Jeffe DB, Smyth MD, Park TS, Piccirillo JF, Limbrick DD. The Chiari Severity Index: a preoperative grading system for Chiari malformation type 1. Neurosurgery. 2015 Mar;76(3):279-85; discussion 285. doi: 10.1227/NEU.0000000000000608.
- Background: PubMed 21591857Vakharia 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.
- Background: PubMed 10834643Munshi 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.
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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.
David D Limbrick, MD, PhD principal investigator
Washington University-St. Louis Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posterior fossa decompression and Dural Augmentation in people with Arnold-Chiari Malformation, Type 1 and Chiari Malformation Type I, run by Washington University School of Medicine 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 5 inclusion and 7 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 31 Oct 2024. 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 31 Oct 2024). 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?
The Number of Participants With Surgical Complications (time frame: less then or equal to 6 months from decompression). 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 NCT02669836, which also lists 45 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 31 Oct 2024.