Clinical trial NCT02949245: Neurologic Complications in Spinal Deformity Surgery - Extension
Official title: Evaluation of Neurologic Complications Associated With Surgical Correction of Adult Spinal Deformity (Scoli-RISK-1): A Prospective, Observational, Multi-center Study 5 Year Follow-up Extension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adult Spinal Deformity
Keywords: Spine
Surgery
Prospective Studies
Deformity
Neurologic deficit
Lead sponsor: AO Foundation, AO Spine
Sponsor class: OTHER
Collaborators: name: Scoliosis Research Society
First posted: 2016-10-31
Enrollment: 77
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: Participant completed Scoli-RISK-1 study are potential subjects for this observational study.

Brief summary: 272 subjects with "high risk" adult spinal deformity requiring surgical correction were enrolled in the previous prospective multi-center international Scoli-RISK-1 study. "High risk" patients were defined by either their diagnoses and/or the type of surgical intervention as listed in the inclusion criteria. Neurological complications in the form of new motor and sensory deficits were monitored prospectively in all patients at hospital discharge, at 6 weeks (± 2 weeks), 6 months (± 2 months) and 24 months (± 2 months) after the surgery. The relationship to the surgical intervention was assessed in all new deficits.

Regression analyses were 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.

All enrolled Scoli-RISK-1 participants will be re-consented and asked to return for a 5 year FU visit.

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. As 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:

* Participant completed Scoli-RISK-1 study (no withdraws or drop-outs)
* Signed informed consent for extended study

Exclusion Criteria:

* Subjects enrolled in Scoli-RISK-1 which are unlikely to comply with the FU
* Subjects which by law are not eligible to participate any longer in clinical trials

Primary outcomes:
measure: Rate of neurologic complication
timeFrame: 5 years postoperative
measure: Absolute change in motor status as measured by the ASIA LEMS
timeFrame: between baseline and 5 years postoperative
Secondary outcomes:
measure: ASIA Sensory Score
timeFrame: Change between baseline and 5 years postoperative
measure: ASIA Impairment Scale
timeFrame: Change between baseline and 5 years postoperative
measure: SRS-22R
timeFrame: Change between baseline and 5 years postoperative
measure: ODI v2.1a
timeFrame: Change between baseline and 5 years postoperative
measure: SF-36 v2.0
timeFrame: Change between baseline and 5 years postoperative
measure: Radiographic measures
timeFrame: Change between baseline and 5 years postoperative
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California
state: California
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
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: 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 Hospital
state: Ontario
city: Hong Kong
country: China
facility: University of Hong Kong
city: NanJing
country: China
facility: Nanjing Drum Tower Hospital
city: Hamamatsu
country: Japan
facility: Hamamatsu 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: