Neurologic Complications in Spinal Deformity Surgery - Extension
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| ClinicalTrials.gov Identifier: NCT02949245 |
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Recruitment Status : Unknown
Verified February 2018 by AOSpine International.
Recruitment status was: Recruiting
First Posted : October 31, 2016
Last Update Posted : April 18, 2018
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Adult Spinal Deformity | Procedure: Interventions |
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
| Study Type : | Observational |
| Estimated Enrollment : | 272 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| 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 |
| Actual Study Start Date : | August 17, 2017 |
| Estimated Primary Completion Date : | February 2019 |
| Estimated Study Completion Date : | February 2020 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Groups/Cohorts
Surgical treatment This observational study is examining the outcomes of standard surgical treatments for adult spinal deformity. |
Procedure: Interventions
Procedure/Surgery: Routinely performed surgical correction of spinal deformity Routinely performed surgical correction of spinal deformity |
- Rate of neurologic complication [ Time Frame: 5 years postoperative ]Rate of treatment-related neurological complications determined by the Clinical Endpoint Committee (CEC) whether complications are of neurological nature or not.
- Absolute change in motor status as measured by the ASIA LEMS [ Time Frame: between baseline and 5 years postoperative ]
- ASIA Sensory Score [ Time Frame: Change between baseline and 5 years postoperative ]Sensory status as measured by the ASIA Sensory Score
- ASIA Impairment Scale [ Time Frame: Change between baseline and 5 years postoperative ]Neurological status as measured by the ASIA Impairment Scale
- SRS-22R [ Time Frame: Change between baseline and 5 years postoperative ]Function, pain and self-image as measured by the SRS-22R
- ODI v2.1a [ Time Frame: Change between baseline and 5 years postoperative ]Functional impairment as measured by the ODI v2.1a score
- SF-36 v2.0 [ Time Frame: Change between baseline and 5 years postoperative ]Quality of life as measured by the SF-36 v2.0
- Radiographic measures [ Time Frame: Change between baseline and 5 years postoperative ]major coronal curve, coronal balance, sagital alignment, T2-T12 sagital cobb, T12-S1 sagital cobb, major sagital curve
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| 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 |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02949245
| Contact: Brigitte S. Gallo, PhD | +41 44 200 24 06 | brigitte.gallo@aofoundation.org | |
| Contact: Niccole Germscheid, Msc | +41 81 414 27 34 | ngermscheid@aospine.org |
| United States, California | |
| University of California | Recruiting |
| San Francisco, California, United States, 94118 | |
| United States, Kentucky | |
| Norton Leatherman Spine Center | Withdrawn |
| Louisville, Kentucky, United States, 40202 | |
| United States, Maryland | |
| Johns Hopkins University | Recruiting |
| Baltimore, Maryland, United States, 21205 | |
| United States, Minnesota | |
| Mayo Clinic | Withdrawn |
| Rochester, Minnesota, United States, 55905 | |
| United States, Missouri | |
| Department of Orthopaedic Surgery, Washington University School of Medicine | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| United States, New York | |
| NYU School of Medicine | Recruiting |
| New York, New York, United States, 10023 | |
| United States, Virginia | |
| University of Virginia | Recruiting |
| Charlottesville, Virginia, United States, 22903 | |
| Canada, Ontario | |
| University of Toronto Hospital | Not yet recruiting |
| Toronto, Ontario, Canada, M5T 2S8 | |
| China | |
| University of Hong Kong | Recruiting |
| Hong Kong, China, 102 | |
| Nanjing Drum Tower Hospital | Recruiting |
| NanJing, China, 210008 | |
| Denmark | |
| Rigshospitalet | Withdrawn |
| Copenhagen, Denmark, 2100 | |
| Japan | |
| Hamamatsu University School of Medicine | Recruiting |
| Hamamatsu, Japan, 3192 | |
| Spain | |
| Hospital Universitari Vall D'Hebron | Recruiting |
| Barcelona, Spain, 08035 | |
| United Kingdom | |
| University Hospital Nottingham, NHS Trust | Not yet recruiting |
| Nottingham, United Kingdom, NG7 2UH | |
| Principal Investigator: | Lawrence Lenke, MD | Scoliosis Research Society |
Additional Information:
| Responsible Party: | AOSpine International |
| ClinicalTrials.gov Identifier: | NCT02949245 |
| Other Study ID Numbers: |
Scoli-RISK-1 extension |
| First Posted: | October 31, 2016 Key Record Dates |
| Last Update Posted: | April 18, 2018 |
| Last Verified: | February 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Spine Surgery Prospective Studies Deformity Neurologic deficit |
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Congenital Abnormalities |