Adult Spinal DeformityNCT01305343
Neurologic Complications in Spinal Deformity Surgery
An observational study of Adult Spinal Deformity, run by AO Foundation, AO Spine at 15 sites in 7 countries.
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. 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?
- Routinely performed surgical correction of spinal deformity
- Type of treatment
- Surgery or procedure
- How many people
- 273 participants
- Where
- 15 sitesin 7 countries
- Study dates
- Aug 2011to Mar 2015
- 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: Patients receiving care at the investigative sites will be pre-screened as potential subjects for this observational study study.
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- Pregnant or nursing women, unable to agree not to become pregnant for a period of 6 months after surgery
- Prisoners
- Institutionalized individuals
Trial locations and contacts
15 sites in 7 countries.
15 sites in 7 countries
United States8 sites
Johns Hopkins University
Baltimore, Maryland, 21205
University of Virginia
Charlottesville, Virginia, 22903
Norton Leatherman Spine Center
Louisville, Kentucky, 40202
Hospital for Special Surgery
New York, New York, 10021
Mayo Clinic
Rochester, Minnesota, 55905
University of California
San Francisco, California, 94118
Department of Orthopaedic Surgery, Washington University School of Medicine
St Louis, Missouri, 63110
NYU School of Medicine
Yew York, New York, 10023
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: A Prospective, Observational, Multi-center Study
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.
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. 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
- Conditions
- Adult Spinal Deformity
- Being tested
- Routinely performed surgical correction of spinal deformity
- Keywords
- Spinal Deformity, Scoliosis, Neurologic complications
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routinely performed surgical correction of spinal deformityProcedure or surgery
Routinely performed surgical correction of spinal deformity
| Study group | Role | What they receive |
|---|---|---|
| Surgical treatment | This observational study is examining the outcomes of standard surgical treatments for adult spinal deformity. Receives: Procedure: Routinely performed surgical correction of spinal deformity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of treatment-related neurologic complication
- Spinal Cord Deficit
- Cauda Equina Deficit
- Nerve Root Deficit
- Motor Deficit
- Sensory Deficit
- Radiculopathy
Measured: 6 months
Secondary outcomes (1)
• Sensory status as measured by the ASIA Sensory Score
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2011 (estimated)
- Study startAug 2011
- Primary completionNov 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 273 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
- NCT01305343
- Sponsor's protocol ID
- Scoli-Risk-1
- Status last verified
- Dec 2015
- First submitted
- 25 Feb 2011
- Last updated
- 24 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33079774
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2015. 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: A Prospective, Observational, Multi-center Study
- ClinicalTrials.gov ID
- NCT01305343
- Acronym / sponsor ID
- Scoli-Risk-1
- Conditions
- Adult Spinal Deformity
- Keywords
- Spinal Deformity, Scoliosis, Neurologic complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- AO Foundation, AO SpineUniversity, hospital or other
- Collaborators
- Scoliosis Research Society
- Study start
- Aug 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 28 Feb 2011 (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.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical treatment | – | Procedure: Routinely performed surgical correction of spinal deformityThis 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
- Patients receiving care at the investigative sites will be pre-screened as potential subjects for this observational study study.
Key inclusion criteria (9 listed)
- 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
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Routinely performed surgical correction of spinal deformityRoutinely performed surgical correction of spinal deformity | Procedure or surgery | Surgical treatment |
Primary outcome
Rate of treatment-related neurologic complication
Time frame: 6 months
* Spinal Cord Deficit * Cauda Equina Deficit * Nerve Root Deficit * Motor Deficit * Sensory Deficit * Radiculopathy
1 secondary outcome
• Sensory status as measured by the ASIA Sensory Score
Time frame: 6 months
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 24 Dec 2015.
- Derived from this study: PubMed 33079774Kwan 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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
15 sites in 7 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 15 sites in 7 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 9 inclusion and 9 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 24 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, China, Canada, Denmark, Japan and 2 more countries. 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 treatment-related neurologic complication (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01305343, which also lists 1 linked publication.
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 24 Dec 2015; AzTrials last refreshed its copy on 30 Oct 2026.