Clinical trial NCT01305343: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adult Spinal Deformity
Keywords: Spinal Deformity
Scoliosis
Neurologic complications
Lead sponsor: AO Foundation, AO Spine
Sponsor class: OTHER
Collaborators: name: Scoliosis Research Society
First posted: 2011-02-28
Enrollment: 273
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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.

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

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

Primary outcomes:
measure: Rate of treatment-related neurologic complication
timeFrame: 6 months
Secondary outcomes:
measure: • Sensory status as measured by the ASIA Sensory Score
timeFrame: 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California
state: California
city: Louisville
country: United States
facility: Norton Leatherman Spine Center
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Department of Orthopaedic Surgery, Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Yew York
country: United States
facility: NYU School of Medicine
state: New York
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Toronto
country: Canada
facility: University of Toronto
city: Hong Kong
country: China
facility: University of Hong Kong
city: NanJing
country: China
facility: Nanjing Drum Tower Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Hamamatsu
country: Japan
facility: University School of Medicine
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D'Hebron
city: Nottingham
country: United Kingdom
facility: University Hospital Nottingham, NHS Trust
Study officials:
affiliation: Scoliosis Research Society
name: Lawrence Lenke, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kwan KYH, Lenke LG, Shaffrey CI, Carreon LY, Dahl BT, Fehlings MG, Ames CP, Boachie-Adjei O, Dekutoski MB, Kebaish KM, Lewis SJ, Matsuyama Y, Mehdian H, Qiu Y, Schwab FJ, Cheung KMC; AO Spine Knowledge Forum Deformity. Are Higher Global Alignment and Proportion Scores Associated With Increased Risks of Mechanical Complications After Adult Spinal Deformity Surgery? An External Validation. Clin Orthop Relat Res. 2021 Feb 1;479(2):312-320. doi: 10.1097/CORR.0000000000001521.