ScoliosisASLSNCT00854828
A Multicenter Prospective Study of Quality of Life in Adult Scoliosis
A study testing Surgical intervention and Non-operative intervention in people with Scoliosis, run by Washington University School of Medicine at 9 sites in 2 countries.
Trial summary
This is a multicenter study evaluating the effectiveness of nonoperative and operative treatments. The investigators wish to identify important clinical and radiographic determinants of outcomes in the management of adults with symptomatic lumbar scoliosis (ASLS). Note: Enrollment was complete July 2014. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Scoliosis
- What is being tested?
- Surgical intervention and Non-operative intervention
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Apr 2010to 28 Feb 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 40 to 80 years with
- ASLS defined as lumbar curve with a coronal Cobb measurement ≥ 30°, and either of the following: Oswestry Disability Index (ODI) score ≥ 20 or SRS-QOL score ≤ 4.0 in the domains of pain, function and/or appearance.
- If assigned to surgical intervention (by randomization or patient preference), the intervention plan would include, at a minimum, the Cobb levels of the Thoracolumbar/lumbar spine.
Who cannot join
- Substantial cardiac, pulmonary, renal or metabolic disease that, in the judgment of the surgical team, would preclude performing an operative procedure without undue risk of morbidity and mortality
- Concomitant high-grade spondylolisthesis (Grade 3)
- Prior thoracic or multiple level lumbar laminectomy or decompression [single or two level lumbar decompression (e.g., herniated disc) will not be an exclusion]
- Prior thoracic or lumbar fusion
- Osteoporosis evidence by a dual-energy x-ray absorptiometry (DEXA) T-score <-3.0 at hip or lumbar spine for patients considered to be at risk (post menopausal females, males > 60 years of age, steroid dependent rheumatoid arthritics, status post organ transplantation, etc.). Patients may be randomized prior to obtaining DEXA results. Non Surgical patients may initiate non surgical treatments prior to completion of DEXA (if required) as non surgical treatments will not affect DEXA results but DEXA must be completed and results entered within 3 months of enrollment. Surgical patient must have DEXA prior to surgical intervention.
- Neuromuscular scoliosis (e.g., spinal muscular atrophy, cerebral palsy, Parkinson's Disease, post-polio syndrome, Charcot Marie Tooth disease)
Show all 12Show fewer
- Congenital scoliosis in the lumbar spine. Congenital anomalies of the cervical or thoracic spine are acceptable.
- Spine tumor, infection or connective tissue disorder
- Cognitively impaired or unable/unwilling to comply with follow-up
- Pregnancy or planning on conceiving during time of study involvement
- Ankylosing Spondylitis
- Past history of vertebroplasty or kyphoplasty of the thoracic or lumbar spine
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States7 sites
Maryland Spine Center
Baltimore, Maryland, 21212
University of Virginia
Charlottesville, Virginia, 22908
Northwestern University
Chicago, Illinois, 60611
University of Louisville
Louisville, Kentucky, 40202
New York University
New York, New York, 10010
Hospital for Special Surgery
New York, New York, 10021
Washington University
St Louis, Missouri, 63110
Canada2 sites
Hopital du Sacre'
Montreal, Quebec, HrJ 1C5
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
About this study
This is a multicenter study evaluating the effectiveness of nonoperative and operative treatments. The investigators wish to identify important clinical and radiographic determinants of outcomes in the management of adults with symptomatic lumbar scoliosis (ASLS).
Note: Enrollment was complete July 2014. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) funding ended 2/28/17. We continue to follow enrolled subjects while we seek additional funding to follow all subjects through 8 years.
Read the detailed description
Specific Aim #1: Compare the outcomes of surgery and nonoperative treatment in patients aged 40 to 80 with ASLS defined as a lumbar curve with a coronal Cobb measurement ≥ 30°, and either of the following: Oswestry (ODI) score of 20 or more; or Scoliosis Research Society Quality of Life instrument (SRS-QOL) score of 4.0 or less, in the domains of pain, function and/or appearance.
Specific Aim #2: Evaluate the impact of patient factors (age, gender, socioeconomic status, education) and comorbidities [mental health, body mass index (BMI) and bone mineral density (BMD)] on adverse events and treatment outcomes for both the nonoperative and operative arms. Incorporate these variables into a prediction model to help identify those patients most likely to benefit from either a surgical or nonoperative approach
- Conditions
- Scoliosis
- Being tested
- Surgical intervention, Non-operative intervention
- Keywords
- Symptomatic 40-80 y/o w/lumbar Cobb of 30 degrees, All Participants must be reasonable surgical candidate at enrollment
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical interventionProcedure or surgery
Surgical intervention as appropriate for adults with symptomatic lumbar scoliosis
Non-operative interventionOther
Non operative intervention as appropriate for treatment of adults with symptomatic lumbar scoliosis such as: injections, medications, physical therapy, etc.
| Study group | Role | What they receive |
|---|---|---|
| Surgical Intervention | Active comparator | Not described Receives: Procedure: Surgical intervention |
| Non-Operative Intervention | Active comparator | Not described Receives: Other: Non-operative intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scoliosis Research Society Quality of Life Questionnaire (SRS QOL) Subscore
Change was calculated as the SRS QOL Subscore value at 2-year minus the value at Baseline for Randomized Cohort (Intent-to-Treat analysis).
SRS QOL Subscore value range is 1 to 5, where 5 is the best score and 1 is the worst score possible.
Measured: Baseline, 2-year
Scoliosis Research Society Quality of Life (SRS QOL) Subscore
Change was calculated as the SRS QOL Subscore value at 2-year as-treated follow-up minus the value at Baseline in the Observational cohort.
SRS QOL Subscore value range is 1 to 5, where 5 is the best score and 1 is the worst score possible.
Measured: Baseline, 2-year
Secondary outcomes (2)
Oswestry Disability Index (ODI) - Randomized Cohort
Change was calculated as the ODI score at 2-year minus the value at Baseline in Randomized Cohort (intent-to-treat analysis).
ODI score range is 0 to 100, where 0 is the best score and 100 is the worst score possible.
Measured: Baseline, 2-year
Oswestry Disability Index (ODI)
Change was calculated as the ODI score at 2-year as treated follow-up minus the value at baseline.
ODI score range is 0 to 100, where 0 is the best score and 100 is the worst score possible.
Measured: Baseline, 2-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2009 (estimated)
- Study startApr 2010
- Primary completion28 Feb 2017
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There were 2 cohorts: Randomized and Observational, each with an operative and non-operative arm.
- Masking
- None (open label)
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Northwestern University, New York University, University of Virginia, University of Louisville, Maryland Spine Center, Hospital for Special Surgery, New York, University Health Network, Toronto, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal, Dartmouth College
- Responsible party
- Sponsor
- Investigators
- Keith H Bridwell, MD, Principal investigator, Washington University School of MedicineJon Lurie, MD, Study director, Dartmouth-Hitchcock Medical CenterChristopher Shaffrey, MD, Study director, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00854828
- Sponsor's protocol ID
- R01AR055176-01A2
- Other IDs
- R01AR055176
- Acronym
- ASLS
- Status last verified
- Aug 2021
- First submitted
- 2 Mar 2009
- Last updated
- 14 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Smith JS, Kelly MP, Yanik EL, Baldus CR, Pham V, Ben-Israel D, Lurie JD, Edwards C, Glassman SD, Lenke LG, Buchowski JM, Carreon LY, Crawford CH 3rd, Lewis SJ, Koski T, Lafage V, Gupta MC, Kim HJ, Ames CP, Bess S, Schwab FJ, Shaffrey CI, Bridwell KH. Operative vs Nonoperative Treatment for Adult Symptomatic Lumbar Scoliosis at 8-Year Follow-Up: A Nonrandomized Clinical Trial. JAMA Surg. 2025 Jun 1;160(6):634-644. doi: 10.1001/jamasurg.2025.0496.
PubMed 40172880Dial BL, Hills JM, Smith JS, Sardi JP, Lazaro B, Shaffrey CI, Bess S, Schwab FJ, Lafage V, Lafage R, Kelly MP, Bridwell KH. The impact of lumbar alignment targets on mechanical complications after adult lumbar scoliosis surgery. Eur Spine J. 2022 Jun;31(6):1573-1582. doi: 10.1007/s00586-022-07200-3. Epub 2022 Apr 15.
PubMed 35428916
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Study of Quality of Life in Adult Scoliosis
- ClinicalTrials.gov ID
- NCT00854828
- Acronym / sponsor ID
- ASLS / R01AR055176-01A2
- Conditions
- Scoliosis
- Keywords
- Symptomatic 40-80 y/o w/lumbar Cobb of 30 degrees, All Participants must be reasonable surgical candidate at enrollment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Northwestern University, New York University, University of Virginia, University of Louisville, Maryland Spine Center, Hospital for Special Surgery, New York, University Health Network, Toronto, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal, Dartmouth College
- Study start
- Apr 2010 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 3 Mar 2009 (estimated)
- Results
- Posted 14 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter study evaluating the effectiveness of nonoperative and operative treatments. The investigators wish to identify important clinical and radiographic determinants of outcomes in the management of adults with symptomatic lumbar scoliosis (ASLS).
Note: Enrollment was complete July 2014. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) funding ended 2/28/17. We continue to follow enrolled subjects while we seek additional funding to follow all subjects through 8 years.
Detailed description
Specific Aim #1: Compare the outcomes of surgery and nonoperative treatment in patients aged 40 to 80 with ASLS defined as a lumbar curve with a coronal Cobb measurement ≥ 30°, and either of the following: Oswestry (ODI) score of 20 or more; or Scoliosis Research Society Quality of Life instrument (SRS-QOL) score of 4.0 or less, in the domains of pain, function and/or appearance.
Specific Aim #2: Evaluate the impact of patient factors (age, gender, socioeconomic status, education) and comorbidities [mental health, body mass index (BMI) and bone mineral density (BMD)] on adverse events and treatment outcomes for both the nonoperative and operative arms. Incorporate these variables into a prediction model to help identify those patients most likely to benefit from either a surgical or nonoperative approach
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There were 2 cohorts: Randomized and Observational, each with an operative and non-operative arm.
| Arm | Type | Receives |
|---|---|---|
| Surgical Intervention | Active comparator | Procedure: Surgical intervention |
| Non-Operative Intervention | Active comparator | Other: Non-operative intervention |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 40 to 80 years with
- ASLS defined as lumbar curve with a coronal Cobb measurement ≥ 30°, and either of the following: Oswestry Disability Index (ODI) score ≥ 20 or SRS-QOL score ≤ 4.0 in the domains of pain, function and/or appearance.
- If assigned to surgical intervention (by randomization or patient preference), the intervention plan would include, at a minimum, the Cobb levels of the Thoracolumbar/lumbar spine.
Key exclusion criteria (12 listed)
- Substantial cardiac, pulmonary, renal or metabolic disease that, in the judgment of the surgical team, would preclude performing an operative procedure without undue risk of morbidity and mortality
- Concomitant high-grade spondylolisthesis (Grade 3)
- Prior thoracic or multiple level lumbar laminectomy or decompression [single or two level lumbar decompression (e.g., herniated disc) will not be an exclusion]
- Prior thoracic or lumbar fusion
- Osteoporosis evidence by a dual-energy x-ray absorptiometry (DEXA) T-score <-3.0 at hip or lumbar spine for patients considered to be at risk (post menopausal females, males > 60 years of age, steroid dependent rheumatoid arthritics, status post organ transplantation, etc.). Patients may be randomized prior to obtaining DEXA results. Non Surgical patients may initiate non surgical treatments prior to completion of DEXA (if required) as non surgical treatments will not affect DEXA results but DEXA must be completed and results entered within 3 months of enrollment. Surgical patient must have DEXA prior to surgical intervention.
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 |
|---|---|---|
| Surgical interventionSurgical intervention as appropriate for adults with symptomatic lumbar scoliosis | Procedure or surgery | Surgical Intervention |
| Non-operative interventionNon operative intervention as appropriate for treatment of adults with symptomatic lumbar scoliosis such as: injections, medications, physical therapy, etc. | Other | Non-Operative Intervention |
Primary outcome
Scoliosis Research Society Quality of Life Questionnaire (SRS QOL) Subscore
Time frame: Baseline, 2-year
Change was calculated as the SRS QOL Subscore value at 2-year minus the value at Baseline for Randomized Cohort (Intent-to-Treat analysis). SRS QOL Subscore value range is 1 to 5, where 5 is the best score and 1 is the worst score possible.
Scoliosis Research Society Quality of Life (SRS QOL) Subscore
Time frame: Baseline, 2-year
Change was calculated as the SRS QOL Subscore value at 2-year as-treated follow-up minus the value at Baseline in the Observational cohort. SRS QOL Subscore value range is 1 to 5, where 5 is the best score and 1 is the worst score possible.
2 secondary outcomes
Oswestry Disability Index (ODI) - Randomized Cohort
Time frame: Baseline, 2-year
Oswestry Disability Index (ODI)
Time frame: Baseline, 2-year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40172880Smith JS, Kelly MP, Yanik EL, Baldus CR, Pham V, Ben-Israel D, Lurie JD, Edwards C, Glassman SD, Lenke LG, Buchowski JM, Carreon LY, Crawford CH 3rd, Lewis SJ, Koski T, Lafage V, Gupta MC, Kim HJ, Ames CP, Bess S, Schwab FJ, Shaffrey CI, Bridwell KH. Operative vs Nonoperative Treatment for Adult Symptomatic Lumbar Scoliosis at 8-Year Follow-Up: A Nonrandomized Clinical Trial. JAMA Surg. 2025 Jun 1;160(6):634-644. doi: 10.1001/jamasurg.2025.0496.
- Derived from this study: PubMed 35428916Dial BL, Hills JM, Smith JS, Sardi JP, Lazaro B, Shaffrey CI, Bess S, Schwab FJ, Lafage V, Lafage R, Kelly MP, Bridwell KH. The impact of lumbar alignment targets on mechanical complications after adult lumbar scoliosis surgery. Eur Spine J. 2022 Jun;31(6):1573-1582. doi: 10.1007/s00586-022-07200-3. Epub 2022 Apr 15.
- Individual participant dataSharing planned: Undecided
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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.
Keith H Bridwell, MD principal investigator
Washington University School of Medicine
Jon Lurie, MD study director
Dartmouth-Hitchcock Medical Center
Christopher Shaffrey, MD study director
University of Virginia
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical intervention and Non-operative intervention in people with Scoliosis, run by Washington University School of Medicine at 9 sites in 2 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 3 inclusion and 12 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 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Canada. 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?
Yes. Results are posted in the registry (first posted 14 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Scoliosis Research Society Quality of Life Questionnaire (SRS QOL) Subscore (time frame: Baseline, 2-year). 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?
On the ClinicalTrials.gov record for NCT00854828, which also lists 2 linked publications.
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 14 Sep 2021.