1. Outcomes in children undergoing posterior fossa decompression and duraplasty with and without tonsillar reduction for Chiari malformation type I and syringomyelia: a pilot prospective multicenter cohort study
- Author
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Timothy M. George, Victor M. Haughton, Robert F. Keating, R. Shane Tubbs, Susan L Rebsamen, Nathan R. Selden, Benjamin C. Warf, Carrie R. Muh, Bermans J. Iskandar, Victoria Rajamanickam, W. Jerry Oakes, Aimee Teo Broman, Joyce Koueik, Ian F. Pollack, Carolina Sandoval-Garcia, David M. Frim, Gerald A. Grant, Brandon G. Rocque, Gerald F. Tuite, and John R. W. Kestle
- Subjects
medicine.medical_specialty ,business.industry ,Decompression ,medicine.medical_treatment ,Posterior fossa ,General Medicine ,medicine.disease ,Surgery ,03 medical and health sciences ,0302 clinical medicine ,CHIARI MALFORMATION TYPE I ,030220 oncology & carcinogenesis ,Clinical endpoint ,Medicine ,Syrinx (medicine) ,business ,030217 neurology & neurosurgery ,Reduction (orthopedic surgery) ,Syringomyelia ,Cohort study - Abstract
OBJECTIVEDespite significant advances in diagnostic and surgical techniques, the surgical management of Chiari malformation type I (CM-I) with associated syringomyelia remains controversial, and the type of surgery performed is surgeon dependent. This study’s goal was to determine the feasibility of a prospective, multicenter, cohort study for CM-I/syringomyelia patients and to provide pilot data that compare posterior fossa decompression and duraplasty (PFDD) with and without tonsillar reduction.METHODSParticipating centers prospectively enrolled children suffering from both CM-I and syringomyelia who were scheduled to undergo surgical decompression. Clinical data were entered into a database preoperatively and at 1–2 weeks, 3–6 months, and 1 year postoperatively. MR images were evaluated by 3 independent, blinded teams of neurosurgeons and neuroradiologists. The primary endpoint was improvement or resolution of the syrinx.RESULTSEight clinical sites were chosen based on the results of a published questionnaire intended to remove geographic and surgeon bias. Data from 68 patients were analyzed after exclusions, and complete clinical and imaging records were obtained for 55 and 58 individuals, respectively. There was strong agreement among the 3 radiology teams, and there was no difference in patient demographics among sites, surgeons, or surgery types. Tonsillar reduction was not associated with > 50% syrinx improvement (RR = 1.22, p = 0.39) or any syrinx improvement (RR = 1.00, p = 0.99). There were no surgical complications.CONCLUSIONSThis study demonstrated the feasibility of a prospective, multicenter surgical trial in CM-I/syringomyelia and provides pilot data indicating no discernible difference in 1-year outcomes between PFDD with and without tonsillar reduction, with power calculations for larger future studies. In addition, the study revealed important technical factors to consider when setting up future trials. The long-term sequelae of tonsillar reduction have not been addressed and would be an important consideration in future investigations.
- Published
- 2020