Scoliosis
Conditions
Keywords
Symptomatic 40-80 y/o w/lumbar Cobb of 30 degrees, All Participants must be reasonable surgical candidate at enrollment
Brief 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. 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
Interventions
PROCEDURESurgical intervention
Surgical intervention as appropriate for adults with symptomatic lumbar scoliosis
OTHERNon-operative intervention
Non operative intervention as appropriate for treatment of adults with symptomatic lumbar scoliosis such as: injections, medications, physical therapy, etc.
Sponsors
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
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
There were 2 cohorts: Randomized and Observational, each with an operative and non-operative arm.
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scoliosis Research Society Quality of Life Questionnaire (SRS QOL) Subscore | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index (ODI) - Randomized Cohort | Baseline, 2-year | 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. |
| Oswestry Disability Index (ODI) | Baseline, 2-year | 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. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Randomized Cohort/Operative Intervention Operative intervention: Operative intervention as appropriate for adults with symptomatic lumbar scoliosis | 30 |
| 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. | 33 |
| Observational Cohort/Operative Intervention Operative intervention: Operative intervention as appropriate for adults with symptomatic lumbar scoliosis | 112 |
| 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. | 111 |
| Total | 286 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 1 | 0 | 0 | 0 |
| Overall Study | Missed 24mo visit | 1 | 1 | 8 | 8 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 | 9 |
Baseline characteristics
| Characteristic | Total | Randomized Cohort/Non-Operative Intervention | Randomized Cohort/Operative Intervention | Observational Cohort/Operative Intervention | Observational Cohort/Non-Operative Intervention |
|---|---|---|---|---|---|
| Age, Continuous | 61 years | 63 years | 63 years | 59 years | 61 years |
| Body Mass Index | 26 units on a scale | 25 units on a scale | 28 units on a scale | 26 units on a scale | 25 units on a scale |
| Coronal balance | 18 millimeters | 23 millimeters | 13 millimeters | 19 millimeters | 14 millimeters |
| Depression/Anxiety/Psychiatric Disorder | 77 Participants | 9 Participants | 11 Participants | 35 Participants | 22 Participants |
| Diabetes No | 272 Participants | 29 Participants | 29 Participants | 108 Participants | 106 Participants |
| Diabetes Yes, controlled with diet | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Diabetes Yes, controlled with oral hypoglycemics | 9 Participants | 3 Participants | 0 Participants | 4 Participants | 2 Participants |
| Diabetes Yes, insulin dependent | 3 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants |
| Duration of back symptoms | 24 Months | 96 Months | 36 Months | 12 Months | 24 Months |
| Duration of leg symptoms | 0 Months | 0 Months | 3 Months | 0 Months | 0 Months |
| Education Bachelor's degree | 72 Participants | 6 Participants | 7 Participants | 28 Participants | 31 Participants |
| Education Graduate degree | 79 Participants | 7 Participants | 7 Participants | 39 Participants | 26 Participants |
| Education High school diploma or GED | 76 Participants | 5 Participants | 7 Participants | 26 Participants | 38 Participants |
| Education Less than high school | 9 Participants | 4 Participants | 1 Participants | 1 Participants | 3 Participants |
| Education Technical or associate's degree | 50 Participants | 11 Participants | 8 Participants | 18 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 0 Participants | 0 Participants | 3 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 270 Participants | 31 Participants | 29 Participants | 106 Participants | 104 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 13 Participants | 2 Participants | 1 Participants | 3 Participants | 7 Participants |
| Hypertension No | 171 Participants | 17 Participants | 16 Participants | 70 Participants | 68 Participants |
| Hypertension Yes, controlled with diet/exercise | 9 Participants | 0 Participants | 1 Participants | 4 Participants | 4 Participants |
| Hypertension Yes, controlled w/medication | 105 Participants | 16 Participants | 13 Participants | 37 Participants | 39 Participants |
| Hypertension Yes, poorly controlled w/medication | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Income per yer <$20,000 | 17 Participants | 2 Participants | 1 Participants | 6 Participants | 8 Participants |
| Income per yer $20,000-39,999 | 31 Participants | 5 Participants | 1 Participants | 11 Participants | 14 Participants |
| Income per yer $40,000-74,999 | 60 Participants | 10 Participants | 9 Participants | 15 Participants | 26 Participants |
| Income per yer $75,000+ | 137 Participants | 13 Participants | 12 Participants | 61 Participants | 51 Participants |
| Income per yer Did not report | 41 Participants | 3 Participants | 7 Participants | 19 Participants | 12 Participants |
| Lumbar Cobb Angle | 51 Degrees | 48 Degrees | 55 Degrees | 57 Degrees | 48 Degrees |
| Lumbar Lordosis (T12-Sacrum) | -40 Degrees | -38 Degrees | -32 Degrees | -38 Degrees | -45 Degrees |
| Numeric Rating Scale (NRS) Back Pain | 6 scores on a scale | 6 scores on a scale | 7 scores on a scale | 7 scores on a scale | 5 scores on a scale |
| Numeric Rating Scale (NRS) Leg Pain | 4 scores on a scale | 5 scores on a scale | 4.5 scores on a scale | 4 scores on a scale | 3 scores on a scale |
| Osteopenia/Osteoporosis None/Does not apply | 112 Participants | 11 Participants | 11 Participants | 42 Participants | 48 Participants |
| Osteopenia/Osteoporosis t-score -1.6 to -2.4 | 75 Participants | 7 Participants | 6 Participants | 29 Participants | 33 Participants |
| Osteopenia/Osteoporosis t-score -1 to -1.5 | 75 Participants | 11 Participants | 12 Participants | 32 Participants | 20 Participants |
| Osteopenia/Osteoporosis t-score -2.5 or worse (or vertebral compression fx | 24 Participants | 4 Participants | 1 Participants | 9 Participants | 10 Participants |
| Oswestry Disability Index (ODI) | 34 scores on a scale | 46 scores on a scale | 34 scores on a scale | 37 scores on a scale | 32 scores on a scale |
| Pelvic Incidence-Lumbar Lordosis Mismatch | 16 Degrees | 25 Degrees | 14 Degrees | 15 Degrees | 13 Degrees |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 1 Participants | 2 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 267 Participants | 32 Participants | 28 Participants | 108 Participants | 99 Participants |
| Region of Enrollment Canada | 19 participants | 7 participants | 4 participants | 5 participants | 3 participants |
| Region of Enrollment United States | 267 participants | 26 participants | 26 participants | 107 participants | 108 participants |
| Sagittal balance (C7 to Sacrum plumb) | 30 millimeters | 34 millimeters | 27 millimeters | 26 millimeters | 33 millimeters |
| Scoliosis Research Society (SRS) Subscore | 3.2 scores on a scale | 2.9 scores on a scale | 3.2 scores on a scale | 3.1 scores on a scale | 3.4 scores on a scale |
| Sex: Female, Male Female | 258 Participants | 29 Participants | 26 Participants | 102 Participants | 101 Participants |
| Sex: Female, Male Male | 28 Participants | 4 Participants | 4 Participants | 10 Participants | 10 Participants |
| SF-12 Physical Component Score | 35 Percentile | 31 Percentile | 34 Percentile | 34 Percentile | 37 Percentile |
| Short form-12 (SF-12) Mental Component Score | 51 Percentile | 51 Percentile | 50 Percentile | 52 Percentile | 51 Percentile |
| Smoking history Current smoker | 17 Participants | 3 Participants | 1 Participants | 6 Participants | 7 Participants |
| Smoking history Former smoker | 87 Participants | 13 Participants | 11 Participants | 31 Participants | 32 Participants |
| Smoking history Never | 182 Participants | 17 Participants | 18 Participants | 75 Participants | 72 Participants |
| SRS Function Domain | 3.4 scores on a scale | 3.0 scores on a scale | 3.2 scores on a scale | 3.2 scores on a scale | 3.4 scores on a scale |
| SRS Mental Health Domain | 3.8 scores on a scale | 4.0 scores on a scale | 3.8 scores on a scale | 3.8 scores on a scale | 3.8 scores on a scale |
| SRS Pain Domain | 2.9 scores on a scale | 2.8 scores on a scale | 3.0 scores on a scale | 2.8 scores on a scale | 3.0 scores on a scale |
| SRS Self-image Domain | 2.8 scores on a scale | 2.8 scores on a scale | 2.8 scores on a scale | 2.8 scores on a scale | 3.0 scores on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 171 | 2 / 150 |
| other Total, other adverse events | 128 / 171 | 70 / 150 |
| serious Total, serious adverse events | 85 / 171 | 41 / 150 |
Outcome results
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.
Time frame: Baseline, 2-year
Population: All randomized participants were included in analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Randomized Surgical Intervention | Scoliosis Research Society Quality of Life Questionnaire (SRS QOL) Subscore | 0.5 score on a scale |
| Randomized Non-Operative Intervention | Scoliosis Research Society Quality of Life Questionnaire (SRS QOL) Subscore | 0.5 score on a scale |
p-value: <0.001Mixed Models Analysis
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.
Time frame: Baseline, 2-year
Population: All Observational participants were included. Crossover participants provided data in both treatment arms.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Randomized Surgical Intervention | Scoliosis Research Society Quality of Life (SRS QOL) Subscore | 0.7 score on a scale |
| Randomized Non-Operative Intervention | Scoliosis Research Society Quality of Life (SRS QOL) Subscore | 0.1 score on a scale |
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.
Time frame: Baseline, 2-year
Population: All observational participants were included. Crossover participants provided data in both arms.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Randomized Surgical Intervention | Oswestry Disability Index (ODI) | -15 score on a scale |
| Randomized Non-Operative Intervention | Oswestry Disability Index (ODI) | -2 score on a scale |
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.
Time frame: Baseline, 2-year
Population: All randomized participants were included.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Randomized Surgical Intervention | Oswestry Disability Index (ODI) - Randomized Cohort | -13 score on a scale |
| Randomized Non-Operative Intervention | Oswestry Disability Index (ODI) - Randomized Cohort | -9 score on a scale |