Neurologic Complications in Spinal Deformity Surgery

Adult Spinal Deformity Clinical Trial

Official title:

Evaluation of Neurologic Complications Associated With Surgical Correction of Adult Spinal Deformity: A Prospective, Observational, Multi-center Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01305343
• Other study ID #: Scoli-Risk-1
• Status: Completed
• Phase: N/A
• First received: February 25, 2011
• Last updated: December 23, 2015
• Start date: August 2011
• Est. completion date: March 2015

Study information

• Verified date: December 2015
• Source: AOSpine International
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardEurope: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 273
• Est. completion date: March 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adult Spinal Deformity
• Congenital Abnormalities

Intervention

Procedure:
• Routinely performed surgical correction of spinal deformity
Routinely performed surgical correction of spinal deformity

Locations

Country	Name	City	State
Canada	University of Toronto	Toronto
China	University of Hong Kong	Hong Kong
China	Nanjing Drum Tower Hospital	NanJing
Denmark	Rigshospitalet	Copenhagen
Japan	University School of Medicine	Hamamatsu
Spain	Hospital Universitari Vall D'Hebron	Barcelona
United Kingdom	University Hospital Nottingham, NHS Trust	Nottingham
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Virginia	Charlottesville	Virginia
United States	Norton Leatherman Spine Center	Louisville	Kentucky
United States	Hospital for Special Surgery	New York	New York
United States	Mayo Clinic	Rochester	Minnesota
United States	Department of Orthopaedic Surgery, Washington University School of Medicine	Saint Louis	Missouri
United States	University of California	San Francisco	California
United States	NYU School of Medicine	Yew York	New York

Sponsors (2)

Lead Sponsor	Collaborator
AOSpine International	Scoliosis Research Society

Countries where clinical trial is conducted

United States,  Canada,  China,  Denmark,  Japan,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of treatment-related neurologic complication	Spinal Cord Deficit; Cauda Equina Deficit; Nerve Root Deficit; Motor Deficit; Sensory Deficit; Radiculopathy	6 months	No
Secondary	• Sensory status as measured by the ASIA Sensory Score		6 months	No

External Links

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