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Trial record 12 of 22 for:    aospine

Neurologic Complications in Spinal Deformity Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01305343
Recruitment Status : Completed
First Posted : February 28, 2011
Last Update Posted : December 24, 2015
Sponsor:
Collaborator:
Scoliosis Research Society
Information provided by (Responsible Party):
AOSpine International

Tracking Information
First Submitted Date February 25, 2011
First Posted Date February 28, 2011
Last Update Posted Date December 24, 2015
Study Start Date August 2011
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 25, 2011)
Rate of treatment-related neurologic complication [ Time Frame: 6 months ]
  • Spinal Cord Deficit
  • Cauda Equina Deficit
  • Nerve Root Deficit
    • Motor Deficit
    • Sensory Deficit
    • Radiculopathy
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 25, 2011)
• Sensory status as measured by the ASIA Sensory Score [ Time Frame: 6 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Neurologic Complications in Spinal Deformity Surgery
Official Title Evaluation of Neurologic Complications Associated With Surgical Correction of Adult Spinal Deformity: A Prospective, Observational, Multi-center Study
Brief 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

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Adult Spinal Deformity
Intervention Procedure: Routinely performed surgical correction of spinal deformity
Routinely performed surgical correction of spinal deformity
Study Groups/Cohorts Surgical treatment
This observational study is examining the outcomes of standard surgical treatments for adult spinal deformity.
Intervention: Procedure: Routinely performed surgical correction of spinal deformity
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 23, 2015)
273
Original Estimated Enrollment
 (submitted: February 25, 2011)
240
Actual Study Completion Date March 2015
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   China,   Denmark,   Japan,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01305343
Other Study ID Numbers Scoli-Risk-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party AOSpine International
Study Sponsor AOSpine International
Collaborators Scoliosis Research Society
Investigators
Principal Investigator: Lawrence Lenke, MD Scoliosis Research Society
PRS Account AOSpine International
Verification Date December 2015