Neurologic Complications in Spinal Deformity Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Scoliosis Research Society
Information provided by (Responsible Party):
AOSpine International
ClinicalTrials.gov Identifier:
NCT01305343
First received: February 25, 2011
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Adult Spinal Deformity
Procedure: Routinely performed surgical correction of spinal deformity

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Neurologic Complications Associated With Surgical Correction of Adult Spinal Deformity: A Prospective, Observational, Multi-center Study

Resource links provided by NLM:


Further study details as provided by AOSpine International:

Primary Outcome Measures:
  • Rate of treatment-related neurologic complication [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    • Spinal Cord Deficit
    • Cauda Equina Deficit
    • Nerve Root Deficit

      • Motor Deficit
      • Sensory Deficit
      • Radiculopathy


Secondary Outcome Measures:
  • • Sensory status as measured by the ASIA Sensory Score [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: August 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Surgical treatment
This observational study is examining the outcomes of standard surgical treatments for adult spinal deformity.
Procedure: Routinely performed surgical correction of spinal deformity
Routinely performed surgical correction of spinal deformity

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • Signed informed consent
  • Age 18 to 80 years old inclusive
  • Diagnosis of adult spinal deformity with an apex of the major deformity in the cervico-thoracic or thoraco-lumbar region (Apex between C7 and L2 inclusive) with any of the following deformity characteristics

    • Primary Scoliosis, Kyphosis or Kyphoscoliosis with major Cobb ≥ 80° in the coronal or sagittal plane
    • Congenital Spinal Deformity undergoing corrective spinal osteotomy
    • Revision Spinal Deformity undergoing corrective spinal osteotomy
  • Any patient undergoing a 3-column spinal osteotomy (i.e. Pedicle Subtraction Osteotomy, Vertebral Column Resection) from C7 to L5 inclusive
  • Any patient with preoperative myelopathy due to their spinal deformity
  • Any patient with ossification of the Ligamentum Flavum or Posterior Longitudinal Ligament and a deformity that needs concomitant reconstruction along with decompression of the spinal cord

Exclusion Criteria:

  • Unlikely to comply with follow-up
  • Recent history ≤ 3 months of substance dependency or psychosocial disturbance
  • Presence of active malignancy
  • Has active, overt bacterial infection, systemic or local
  • Recent (≤3 months) history of significant spinal trauma/injury/ fracture/malignancy in the spinal region
  • Patients with complete, long term paraplegia
  • Pregnant or nursing women, unable to agree not to become pregnant for a period of 6 months after surgery
  • Prisoners
  • Institutionalized individuals
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01305343

Locations
United States, California
University of California
San Francisco, California, United States, 94118
United States, Kentucky
Norton Leatherman Spine Center
Louisville, Kentucky, United States, 40202
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Department of Orthopaedic Surgery, Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
NYU School of Medicine
Yew York, New York, United States, 10023
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22903
Canada
University of Toronto
Toronto, Canada, M5T 2S8
China
University of Hong Kong
Hong Kong, China, 102
Nanjing Drum Tower Hospital
NanJing, China, 210008
Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Japan
University School of Medicine
Hamamatsu, Japan, 3192
Spain
Hospital Universitari Vall D'Hebron
Barcelona, Spain, 08035
United Kingdom
University Hospital Nottingham, NHS Trust
Nottingham, United Kingdom, NG7 2UH
Sponsors and Collaborators
AOSpine International
Scoliosis Research Society
Investigators
Principal Investigator: Lawrence Lenke, MD Scoliosis Research Society
  More Information

Additional Information:
No publications provided

Responsible Party: AOSpine International
ClinicalTrials.gov Identifier: NCT01305343     History of Changes
Other Study ID Numbers: Scoli-Risk-1
Study First Received: February 25, 2011
Last Updated: October 28, 2013
Health Authority: United States: Institutional Review Board
Europe: Ethics Committee

Keywords provided by AOSpine International:
Spinal Deformity
Scoliosis
Neurologic complications

Additional relevant MeSH terms:
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 28, 2014