Neurologic Complications in Spinal Deformity Surgery

• ClinicalTrials.gov Identifier: NCT01305343
• Recruitment Status: Completed
• First Posted: February 28, 2011
• Last Update Posted: December 24, 2015
• Sponsor: AOSpine International
• Collaborator: Scoliosis Research Society
• Information provided by (Responsible Party): AOSpine International

Study Description

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.

Condition or disease	Intervention/treatment
Adult Spinal Deformity	Procedure: 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

Study Design

• Study Type: Observational
• Actual Enrollment: 273 participants
• 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
• Study Start Date: August 2011
• Actual Primary Completion Date: November 2014
• Actual Study Completion Date: March 2015

Groups and Cohorts

Group/Cohort	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Rate of treatment-related neurologic complication [ Time Frame: 6 months ]
   • Spinal Cord Deficit
   • Cauda Equina Deficit

   • Nerve Root Deficit

     • Motor Deficit
     • Sensory Deficit
     • Radiculopathy

Secondary Outcome Measures :

1. • Sensory status as measured by the ASIA Sensory Score [ Time Frame: 6 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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:

Related Info  Related Info 

• Responsible Party: AOSpine International
• ClinicalTrials.gov Identifier: NCT01305343
• Other Study ID Numbers: Scoli-Risk-1
• First Posted: February 28, 2011
• Last Update Posted: December 24, 2015
• Last Verified: December 2015

Keywords provided by AOSpine International:

Spinal Deformity; Scoliosis; Neurologic complications

Additional relevant MeSH terms:

Congenital Abnormalities