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| ID | Type | Description | Link |
|---|---|---|---|
| R01AR055176 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
| Northwestern University | OTHER |
| New York University | OTHER |
| University of Virginia |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical Intervention | Active Comparator |
| |
| Non-Operative Intervention | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical intervention | Procedure | Surgical intervention as appropriate for adults with symptomatic lumbar scoliosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline, 2-year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 2-year |
| Oswestry Disability Index (ODI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keith H Bridwell, MD | Washington University School of Medicine | Principal Investigator |
| Jon Lurie, MD | Dartmouth-Hitchcock Medical Center | Study Director |
| Christopher Shaffrey, MD | University of Virginia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States | ||
| University of Louisville |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40172880 | Derived | 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. | |
| 35428916 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Randomized Cohort/Operative Intervention | Operative intervention: Operative intervention as appropriate for adults with symptomatic lumbar scoliosis. |
| FG001 | Randomized Cohort/Non-Operative Intervention | Non-operative intervention: Non operative intervention as appropriate for treatment of adults with symptomatic lumbar scoliosis such as: injections, medications, physical therapy, etc. |
| FG002 | Observational Cohort/Operative Intervention | Operative intervention: Operative intervention as appropriate for adults with symptomatic lumbar scoliosis. |
| FG003 | Observational Cohort/Non-Operative Intervention | Non-operative intervention: Non operative intervention as appropriate for treatment of adults with symptomatic lumbar scoliosis such as: injections, medications, physical therapy, etc. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Symptomatic adult lumbar scoliosis patients (ages 40-80, lumbar Cobb measurement >30° and Oswestry Disability Index (ODI) >20 or Scoliosis Research Society-22 <4.0) with no prior history of scoliosis surgery from 9 North American centers were enrolled in randomized or observational cohorts to evaluate surgery versus nonoperative treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Randomized Cohort/Operative Intervention | Operative intervention: Operative intervention as appropriate for adults with symptomatic lumbar scoliosis |
| BG001 | Randomized Cohort/Non-Operative Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All randomized participants were included in analysis. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, 2-year |
|
Adverse events were monitored/assessed in each participant from enrollment through study completion (end of funding), an average of 3.6 years. Specific amount of time for each individual is dependent upon when he/she entered the study and if/when they withdrew from the study.
Serious Adverse Events (SAE) were any events that resulted in:
Death Hospitalization (new or prolonged) - Exception was hospitalization for index spinal deformity correction surgery.
New disability (significant or permanent) Life threatening Unexpected but Reasonably Related to the Intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Surgical Intervention-As Treated AE's Occurring While Patient Was in Surgical Arm | Surgical intervention: Surgical intervention as appropriate for adults with symptomatic lumbar scoliosis. AE's are reported in the treatment arm (surgical or non-operative) patient was in at time of AE. A total of 171 patients had surgical intervention. This number includes non operative patients who crossed over to surgical intervention. Some patients spent time and had AEs in both treatment arms. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Surveillance, Epidemiology and End Results (SEER) Cancers | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Musculoskeletal Event (excluding spine related symptoms) | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Keith H. Bridwell, MD | Washington University | 314-747-2655 | bridwellk@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 23, 2015 | Apr 16, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 23, 2015 | Apr 16, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012600 | Scoliosis |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| OTHER |
| University of Louisville | OTHER |
| Maryland Spine Center | OTHER |
| Hospital for Special Surgery, New York | OTHER |
| University Health Network, Toronto | OTHER |
| Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal | OTHER |
| Dartmouth College | OTHER |
There were 2 cohorts: Randomized and Observational, each with an operative and non-operative arm.
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| Non-operative intervention | Other | Non operative intervention as appropriate for treatment of adults with symptomatic lumbar scoliosis such as: injections, medications, physical therapy, etc. |
|
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. |
| Baseline, 2-year |
| Louisville |
| Kentucky |
| 40202 |
| United States |
| Maryland Spine Center | Baltimore | Maryland | 21212 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| New York University | New York | New York | 10010 | United States |
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Toronto Western Hospital | Toronto | Ontario | M5T 2S8 | Canada |
| Hopital du Sacre' | Montreal | Quebec | HrJ 1C5 | Canada |
| Dial 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. |
| Withdrawal by Subject |
|
| Missed 24mo visit |
|
Non-operative intervention: Non operative intervention as appropriate for treatment of adults with symptomatic lumbar scoliosis such as: injections, medications, physical therapy, etc.
| BG002 | Observational Cohort/Operative Intervention | Operative intervention: Operative intervention as appropriate for adults with symptomatic lumbar scoliosis |
| BG003 | Observational Cohort/Non-Operative Intervention | Non-operative intervention: Non operative intervention as appropriate for treatment of adults with symptomatic lumbar scoliosis such as: injections, medications, physical therapy, etc. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Scoliosis Research Society (SRS) Subscore | Scores range from 1 (worst score) to 5 (best score). | Median | Inter-Quartile Range | scores on a scale |
|
| SRS Pain Domain | Scores range from 1 (worst score) to 5 (best score). | Median | Inter-Quartile Range | scores on a scale |
|
| SRS Function Domain | Scores range from 1 (worst score) to 5 (best score). | Median | Inter-Quartile Range | scores on a scale |
|
| SRS Self-image Domain | Scores range from 1 (worst score) to 5 (best score). | Median | Inter-Quartile Range | scores on a scale |
|
| SRS Mental Health Domain | Scores range from 1 (worst score) to 5 (best score). | Median | Inter-Quartile Range | scores on a scale |
|
| Oswestry Disability Index (ODI) | Scores range from 100 (worst score) to 0 (best score). | Median | Inter-Quartile Range | scores on a scale |
|
| Numeric Rating Scale (NRS) Back Pain | Scores range from 10 (worst score) to 0 (best score). | Median | Inter-Quartile Range | scores on a scale |
|
| Numeric Rating Scale (NRS) Leg Pain | Scores range from 10 (worst score) to 0 (best score). | Median | Inter-Quartile Range | scores on a scale |
|
| Short form-12 (SF-12) Mental Component Score | Percentiles range from 0 to 100 with 'norm' being 50. | Median | Inter-Quartile Range | Percentile |
|
| SF-12 Physical Component Score | Percentiles range from 0 to 100 with 'norm' being 50. | Median | Inter-Quartile Range | Percentile |
|
| Lumbar Cobb Angle | Lumbar Cobb angle is the measurement of the scoliosis (curve in the coronal plane) measured in degrees. Normal is 0. | Median | Inter-Quartile Range | Degrees |
|
| Lumbar Lordosis (T12-Sacrum) | Lumbar lordosis is the sagittal plane measurement of T12 to S1 in degrees. Mean for normal adults is 64 degrees +/- 10 degrees based on 'An analysis of sagittal spinal alignment in 100 asymptomatic middle and older aged volunteers' published in SPINE, Vol 20, number 12, pp 1351-1358 in 1995. | Median | Inter-Quartile Range | Degrees |
|
| Sagittal balance (C7 to Sacrum plumb) | Measured in mm from mid body C7 to front of plumb in sagittal plane. Negative value indicates C7 plumb falls BEHIND sacrum. Ideal would be 0mm. | Median | Inter-Quartile Range | millimeters |
|
| Coronal balance | Measure (in mm) mid body C7 to mid Sacrum plumb in coronal plane, Values reported in absolute values. Ideal = 0mm. | Median | Inter-Quartile Range | millimeters |
|
| Pelvic Incidence-Lumbar Lordosis Mismatch | Mathematical difference between pelvic incidence and lumbar lordosis radiographic measurements in degrees. Differences > 10 degrees correlates with worse patient reported outcomes. | Median | Inter-Quartile Range | Degrees |
|
| Education | Count of Participants | Participants |
|
| Income per yer | Count of Participants | Participants |
|
| Smoking history | Count of Participants | Participants |
|
| Body Mass Index | Normal adult BMI is 18.5 to 24.9 | Median | Inter-Quartile Range | units on a scale |
|
| Osteopenia/Osteoporosis | Count of Participants | Participants |
|
| Hypertension | Count of Participants | Participants |
|
| Diabetes | Count of Participants | Participants |
|
| Depression/Anxiety/Psychiatric Disorder | Count of Participants | Participants |
|
| Duration of back symptoms | Median | Inter-Quartile Range | Months |
|
| Duration of leg symptoms | Length of time patient reported having Leg symptoms at time of enrollment. If no leg symptoms, patient reported 0 months. | Median | Inter-Quartile Range | Months |
|
Patients consenting to randomization and assigned to Non-operative intervention: Non operative intervention as appropriate for treatment of adults with symptomatic lumbar scoliosis such as: injections, medications, physical therapy, etc. |
|
|
|
| Primary | 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. | All Observational participants were included. Crossover participants provided data in both treatment arms. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, 2-year |
|
|
|
| Secondary | 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. | All randomized participants were included. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, 2-year |
|
|
|
| Secondary | 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. | All observational participants were included. Crossover participants provided data in both arms. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, 2-year |
|
|
|
| 3 |
| 171 |
| 85 |
| 171 |
| 128 |
| 171 |
| EG001 | Non-Operative Intervention-As Treated AE's Occurring While Patient Was on Non Operative Arm | Non-operative intervention: Non operative intervention as appropriate for treatment of adults with symptomatic lumbar scoliosis such as: injections, medications, physical therapy, etc. AE's are reported in the treatment arm (surgical or non-operative) patient was in at time of AE. A total of 150 had non operative interventions. | 2 | 150 | 41 | 150 | 70 | 150 |
All Surveillance, Epidemiology and End Results (SEER) cancers occurring during the study were considered an SAE
|
| Cardiac Events | Cardiac disorders | Non-systematic Assessment | Cardiac events that met NIAMS SAE criteria |
|
| Gastrointestinal Events | Gastrointestinal disorders | Non-systematic Assessment | GI events that met NIAMS SAE definitions |
|
| Genitourinary Event | Renal and urinary disorders | Non-systematic Assessment | Genitourinary events meeting NIAMS SAE reporting criteria |
|
| Pulmonary Event | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Pulmonary related events meeting NIAMS SAE reporting guidelines |
|
| Surgeries Unrelated to Adult Symptomatic Lumbar Scoliosis | General disorders | Non-systematic Assessment | Surgical events NOT related to adult scoliosis resulting new hospitalization |
|
| Miscellaneous SAE | General disorders | Non-systematic Assessment | Misc events meeting NIAMS SAE criteria. Examples: Accidental injury, Dehydration, Altered metal status, Panic Attack, C spine stenosis, septic arthritis, anaphylactic shock, Addison's disease |
|
| Adult Lumbar Scoliosis Events | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Adult Scoliosis events meeting NIAMS SAE criteria. Examples: Lumbar stenosis, revision scoliosis spine surgeries) |
|
| Circulatory Disorders | Vascular disorders | Non-systematic Assessment | Circulatory Events meeting NIAMS SAE criteria such as transient ischemic attack, cerebrovascular accident, Deep Vein Thrombosis, Pulmonary Embolism) |
|
| Medication Reaction | General disorders | Non-systematic Assessment |
|
| Endocrine System Events | Endocrine disorders | Non-systematic Assessment |
|
| Gastrointestinal Event | Gastrointestinal disorders | Non-systematic Assessment |
|
| Genitourinary Events | Renal and urinary disorders | Non-systematic Assessment |
|
| Cardiac events | Cardiac disorders | Non-systematic Assessment |
|
| Circulatory Events | Vascular disorders | Non-systematic Assessment |
|
| Hypertensive events | General disorders | Non-systematic Assessment |
|
| Non SEER cancer | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Basal and squamous cell skin cancers |
|
| Respiratory Events | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Infectious Event (non spine) | Infections and infestations | Non-systematic Assessment | Ear, sinus, lyme disease, infected bites, herpes, etc. |
|
| Psychosocial Events | Social circumstances | Non-systematic Assessment |
|
| Reproductive | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Vision Events | Eye disorders | Non-systematic Assessment |
|
| Misc events | General disorders | Non-systematic Assessment | Shingles, Low B12, tinnitus, syncope, restless leg syndrome, cat bite, neuropathies d/t chemo, etc. |
|
| Cerebrospinal fluid leak (intra-op) | Surgical and medical procedures | Non-systematic Assessment |
|
| Excessive blood loss/Intraop Coagulopathy | Surgical and medical procedures | Non-systematic Assessment |
|
| Ineffective fixation/Posterior element fracture | Surgical and medical procedures | Non-systematic Assessment |
|
| Spinal implant failure (no revision) | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Spinal implant failure (rod fracture, hook/screw pull out, etc) that did not require revision surgery prior to end of funding. Those failures that were revised were considered SAE and reported under SAEs |
|
| Proximal junctional kyphosis/breakdown (No revision required) | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Proximal breakdown that required revision surgery during funding is considered an SAE and reported as SAE. |
|
| Spine wound problems (Not requiring admission) | Infections and infestations | Non-systematic Assessment | Superficial and deep wound infections that did not require a hospitalization. If hospitalization was required, it was considered an SAE and is reported under SAEs |
|
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