Adult Spinal DeformityNCT02949245
Neurologic Complications in Spinal Deformity Surgery - Extension
An observational study of Adult Spinal Deformity, run by AO Foundation, AO Spine at 11 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Adult Spinal Deformity
- What is being tested?
- Interventions
- Type of treatment
- Surgery or procedure
- How many people
- 77 participants
- Where
- 11 sitesin 6 countries
- Study dates
- 17 Aug 2017to 28 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participant completed Scoli-RISK-1 study are potential subjects for this observational study.
Who may be able to join
- Participant completed Scoli-RISK-1 study (no withdraws or drop-outs)
- Signed informed consent for extended study
Who cannot join
- 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
Trial locations and contacts
11 sites in 6 countries.
11 sites in 6 countries
United States5 sites
Johns Hopkins University
Baltimore, Maryland, 21205
University of Virginia
Charlottesville, Virginia, 22903
NYU School of Medicine
New York, New York, 10023
University of California
San Francisco, California, 94118
Department of Orthopaedic Surgery, Washington University School of Medicine
St Louis, Missouri, 63110
China2 sites
University of Hong Kong
Hong Kong, 102
Nanjing Drum Tower Hospital
Nanjing, 210008
United Kingdom1 site
University Hospital Nottingham, NHS Trust
Nottingham, NG7 2UH
About this study
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
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.
Read the 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
- Conditions
- Adult Spinal Deformity
- Being tested
- Interventions
- Keywords
- Spine, Surgery, Prospective Studies, Deformity, Neurologic deficit
- Medical subject headings
- Congenital Abnormalities, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionsProcedure or surgery
Procedure/Surgery: Routinely performed surgical correction of spinal deformity
Routinely performed surgical correction of spinal deformity
| Study group | Role | What they receive |
|---|---|---|
| Groups/Cohorts | Surgical treatment
This observational study is examining the outcomes of standard surgical treatments for adult spinal deformity. Receives: Procedure: Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of neurologic complication
Rate of treatment-related neurological complications determined by the Clinical Endpoint Committee (CEC) whether complications are of neurological nature or not.
Measured: 5 years postoperative
Absolute change in motor status as measured by the ASIA LEMS
Measured: between baseline and 5 years postoperative
Secondary outcomes (6)
ASIA Sensory Score
Sensory status as measured by the ASIA Sensory Score
Measured: Change between baseline and 5 years postoperative
ASIA Impairment Scale
Neurological status as measured by the ASIA Impairment Scale
Measured: Change between baseline and 5 years postoperative
SRS-22R
Function, pain and self-image as measured by the SRS-22R
Measured: Change between baseline and 5 years postoperative
ODI v2.1a
Functional impairment as measured by the ODI v2.1a score
Measured: Change between baseline and 5 years postoperative
SF-36 v2.0
Quality of life as measured by the SF-36 v2.0
Measured: Change between baseline and 5 years postoperative
Radiographic measures
major coronal curve, coronal balance, sagital alignment, T2-T12 sagital cobb, T12-S1 sagital cobb, major sagital curve
Measured: Change between baseline and 5 years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study start17 Aug 2017
- Primary completion28 Dec 2019
- Study completion28 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Spinal DeformityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Foundation, AO Spine
- Sponsor type
- University, hospital or other
- Collaborators
- Scoliosis Research Society
- Responsible party
- Sponsor
- Investigators
- Lawrence Lenke, MD, Principal investigator, Scoliosis Research Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02949245
- Sponsor's protocol ID
- Scoli-RISK-1 extension
- Status last verified
- May 2020
- First submitted
- 24 Oct 2016
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02949245
- Acronym / sponsor ID
- Scoli-RISK-1 extension
- Conditions
- Adult Spinal Deformity
- Keywords
- Spine, Surgery, Prospective Studies, Deformity, Neurologic deficit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- AO Foundation, AO SpineUniversity, hospital or other
- Collaborators
- Scoliosis Research Society
- Study start
- 17 Aug 2017 (actual)
- Primary completion
- 28 Dec 2019 (actual)
- Study completion
- 28 Dec 2019 (actual)
- First posted
- 31 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Groups/Cohorts | – | Procedure: InterventionsSurgical treatment This observational study is examining the outcomes of standard surgical treatments for adult spinal deformity. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participant completed Scoli-RISK-1 study are potential subjects for this observational study.
Key inclusion criteria (2 listed)
- Participant completed Scoli-RISK-1 study (no withdraws or drop-outs)
- Signed informed consent for extended study
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionsProcedure/Surgery: Routinely performed surgical correction of spinal deformity Routinely performed surgical correction of spinal deformity | Procedure or surgery | Groups/Cohorts |
Primary outcome
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
6 secondary outcomes
ASIA Sensory Score
Time frame: Change between baseline and 5 years postoperative
ASIA Impairment Scale
Time frame: Change between baseline and 5 years postoperative
SRS-22R
Time frame: Change between baseline and 5 years postoperative
ODI v2.1a
Time frame: Change between baseline and 5 years postoperative
SF-36 v2.0
Time frame: Change between baseline and 5 years postoperative
Radiographic measures
Time frame: Change between baseline and 5 years postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Adult Spinal Deformity
Not yet recruiting
SALVAGE Trial (Safety And cLinical Value of AutoloGous rEinfusion)
Adult Spinal Deformity Surgery
Active, not recruitingObservational study
Evaluation of Safety of Complex Pedicle Screw Trajectories Using Patient-Specific Guides (MySpine, Medacta)
Scoliosis Idiopathic, Scoliosis Idiopathic Adolescent
Enrolling by invitation
Essential Amino Acid Supplementation in Adult Spinal Deformity Patients
Adult Spinal Deformity
Recruiting
Feasibility of Wireless Continuous Vital Sign Monitoring and Impact on Patients Undergoing Adult Spinal Surgery in a General Ward
Adult Spinal Deformity, Wireless Continuous Vital Signs Monitoring
RecruitingObservational study
Complex Adult Deformity Surgery (CADS)
Adult Spinal Deformity, Scoliosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence Lenke, MD principal investigator
Scoliosis Research Society
11 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adult Spinal Deformity, run by AO Foundation, AO Spine at 11 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, China, Canada, Japan, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of neurologic complication (time frame: 5 years postoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2020; AzTrials last refreshed its copy on 1 Nov 2026.