Neurologic Complications in Spinal Deformity Surgery
Condition: Adult Spinal Deformity
MeSH terms: Congenital Abnormalities
Study type: Observational

Summary: 
      240 subjects with "high risk" adult spinal deformity requiring surgical correction will be
      enrolled in a prospective multi-center international study. "High risk" patients are defined
      by either their diagnoses and/or the type of surgical intervention as listed in the inclusion
      criteria. Neurologic complications in the form of new motor and sensory deficits will be
      monitored prospectively in all patients at hospital discharge, and at 6 weeks (± 2 weeks) six
      months (± 2 months) and 24 months(± 2 months) after the surgery. All new deficits will be
      adjudicated for relationship to the surgical intervention.

      Regression analyses will be used to evaluate the association between patient demographics, co
      morbidities, treatment history, spinal deformity characteristics, surgical characteristics,
      non-neurologic complications and pre-surgical status to occurrence of a neurologic deficit
      after surgery.
    

Detailed description: 
      Although the incidence of complications in patients undergoing correction of their spinal
      deformity has been reported extensively, the majority of these studies were retrospective.
      There were only five studies, three from a single institution, with prospectively collected
      data that specifically identified complications. The largest series was from Buchowski et al
      who reported on 108 patients with fixed sagittal deformity undergoing Pedicle Subtraction
      Osteotomy (PSO) with a 14% over-all complication rate with motor weakness in 11 patients and
      neurogenic bladder in one patient, of which 3 were permanent. Yang reported on 35 patients
      undergoing PSOs with a 46% over-all complication rate and one transient nerve root motor
      deficit. Ahn in 2002 reported on 83 patients undergoing various osteotomies for sagittal
      imbalance and reported a 34% over-all complication rate with 3 permanent and 3 transient
      nerve root deficits.

      Given this lack of information, there is a need to determine the true incidence of
      complications using a prospective multi-center design. There is a need to identify neurologic
      deficits in a more systematic fashion to include spinal cord, cauda equina and nerve root
      deficits as well as radiculopathies. The risk factors associated with the occurrence of a
      complication, especially a neurologic complication, also needs to be more fully elucidated.
      This is increasingly relevant, as newer surgical techniques allow for more aggressive
      correction of the spinal deformity that may put the spinal cord and nerve roots at increased
      risk. Valid data on the incidence and types of neurologic deficits is also needed in order to
      study newer drugs that are available that may mitigate this risk.

      The primary objectives of this study are: (i) to establish the incidence of neurologic
      deficit in "high risk" adult patients undergoing correction of their spinal deformity of
      adult spinal deformity and (ii) to identify characteristics associated with increased risk of
      neurologic complications. Secondary objectives include (i) to determine the incidence of all
      complications related to surgical correction of "high risk" adult spinal deformity; (ii) to
      determine the short-term clinical outcomes in patients undergoing correction of their spinal
      deformity and (iii).to determine amount of radiographic and clinical correction of deformity
    

Intervention name(s): Routinely performed surgical correction of spinal deformity
Intervention type(s): Procedure
Intervention description(s): Routinely performed surgical correction of spinal deformity
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients receiving care at the investigative sites will be pre-screened as potential
        subjects for this observational study study.
      
Keywords: Spinal Deformity; Scoliosis; Neurologic complications