Trial Outcomes & Findings for A Multicenter Prospective Study of Quality of Life in Adult Scoliosis (NCT NCT00854828)

Last Updated: 2021-09-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

286 participants

Primary outcome timeframe

Baseline, 2-year

Results posted on

2021-09-14

Participant Flow

Participant milestones

Participant milestones
Measure	Randomized Cohort/Operative Intervention Operative intervention: Operative intervention as appropriate for adults with symptomatic lumbar scoliosis.	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.	Observational Cohort/Operative Intervention Operative intervention: Operative intervention as appropriate for adults with symptomatic lumbar scoliosis.	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.
Overall Study STARTED	30	33	112	111
Overall Study 3 Months Post Intervention	24	32	112	106
Overall Study 12 Months Post Intervention	26	32	112	101
Overall Study 24 Months Post Intervention	27	31	104	94
Overall Study COMPLETED	27	31	104	94
Overall Study NOT COMPLETED	3	2	8	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Randomized Cohort/Operative Intervention Operative intervention: Operative intervention as appropriate for adults with symptomatic lumbar scoliosis.	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.	Observational Cohort/Operative Intervention Operative intervention: Operative intervention as appropriate for adults with symptomatic lumbar scoliosis.	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.
Overall Study Death	1	0	0	0
Overall Study Withdrawal by Subject	1	1	0	9
Overall Study Missed 24mo visit	1	1	8	8

Baseline Characteristics

A Multicenter Prospective Study of Quality of Life in Adult Scoliosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Randomized Cohort/Operative Intervention n=30 Participants Operative intervention: Operative intervention as appropriate for adults with symptomatic lumbar scoliosis	Randomized Cohort/Non-Operative Intervention n=33 Participants Non-operative intervention: Non operative intervention as appropriate for treatment of adults with symptomatic lumbar scoliosis such as: injections, medications, physical therapy, etc.	Observational Cohort/Operative Intervention n=112 Participants Operative intervention: Operative intervention as appropriate for adults with symptomatic lumbar scoliosis	Observational Cohort/Non-Operative Intervention n=111 Participants Non-operative intervention: Non operative intervention as appropriate for treatment of adults with symptomatic lumbar scoliosis such as: injections, medications, physical therapy, etc.	Total n=286 Participants Total of all reporting groups
Age, Continuous	63 years n=93 Participants	63 years n=4 Participants	59 years n=27 Participants	61 years n=483 Participants	61 years n=36 Participants
Sex: Female, Male Female	26 Participants n=93 Participants	29 Participants n=4 Participants	102 Participants n=27 Participants	101 Participants n=483 Participants	258 Participants n=36 Participants
Sex: Female, Male Male	4 Participants n=93 Participants	4 Participants n=4 Participants	10 Participants n=27 Participants	10 Participants n=483 Participants	28 Participants n=36 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	3 Participants n=27 Participants	0 Participants n=483 Participants	3 Participants n=36 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=93 Participants	31 Participants n=4 Participants	106 Participants n=27 Participants	104 Participants n=483 Participants	270 Participants n=36 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants	7 Participants n=483 Participants	13 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants	2 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants	8 Participants n=483 Participants	13 Participants n=36 Participants
Race (NIH/OMB) White	28 Participants n=93 Participants	32 Participants n=4 Participants	108 Participants n=27 Participants	99 Participants n=483 Participants	267 Participants n=36 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	2 Participants n=483 Participants	2 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants	2 Participants n=36 Participants
Region of Enrollment Canada	4 participants n=93 Participants	7 participants n=4 Participants	5 participants n=27 Participants	3 participants n=483 Participants	19 participants n=36 Participants
Region of Enrollment United States	26 participants n=93 Participants	26 participants n=4 Participants	107 participants n=27 Participants	108 participants n=483 Participants	267 participants n=36 Participants
Scoliosis Research Society (SRS) Subscore	3.2 scores on a scale n=93 Participants	2.9 scores on a scale n=4 Participants	3.1 scores on a scale n=27 Participants	3.4 scores on a scale n=483 Participants	3.2 scores on a scale n=36 Participants
SRS Pain Domain	3.0 scores on a scale n=93 Participants	2.8 scores on a scale n=4 Participants	2.8 scores on a scale n=27 Participants	3.0 scores on a scale n=483 Participants	2.9 scores on a scale n=36 Participants
SRS Function Domain	3.2 scores on a scale n=93 Participants	3.0 scores on a scale n=4 Participants	3.2 scores on a scale n=27 Participants	3.4 scores on a scale n=483 Participants	3.4 scores on a scale n=36 Participants
SRS Self-image Domain	2.8 scores on a scale n=93 Participants	2.8 scores on a scale n=4 Participants	2.8 scores on a scale n=27 Participants	3.0 scores on a scale n=483 Participants	2.8 scores on a scale n=36 Participants
SRS Mental Health Domain	3.8 scores on a scale n=93 Participants	4.0 scores on a scale n=4 Participants	3.8 scores on a scale n=27 Participants	3.8 scores on a scale n=483 Participants	3.8 scores on a scale n=36 Participants
Oswestry Disability Index (ODI)	34 scores on a scale n=93 Participants	46 scores on a scale n=4 Participants	37 scores on a scale n=27 Participants	32 scores on a scale n=483 Participants	34 scores on a scale n=36 Participants
Numeric Rating Scale (NRS) Back Pain	7 scores on a scale n=93 Participants	6 scores on a scale n=4 Participants	7 scores on a scale n=27 Participants	5 scores on a scale n=483 Participants	6 scores on a scale n=36 Participants
Numeric Rating Scale (NRS) Leg Pain	4.5 scores on a scale n=93 Participants	5 scores on a scale n=4 Participants	4 scores on a scale n=27 Participants	3 scores on a scale n=483 Participants	4 scores on a scale n=36 Participants
Short form-12 (SF-12) Mental Component Score	50 Percentile n=93 Participants	51 Percentile n=4 Participants	52 Percentile n=27 Participants	51 Percentile n=483 Participants	51 Percentile n=36 Participants
SF-12 Physical Component Score	34 Percentile n=93 Participants	31 Percentile n=4 Participants	34 Percentile n=27 Participants	37 Percentile n=483 Participants	35 Percentile n=36 Participants
Lumbar Cobb Angle	55 Degrees n=93 Participants	48 Degrees n=4 Participants	57 Degrees n=27 Participants	48 Degrees n=483 Participants	51 Degrees n=36 Participants
Lumbar Lordosis (T12-Sacrum)	-32 Degrees n=93 Participants	-38 Degrees n=4 Participants	-38 Degrees n=27 Participants	-45 Degrees n=483 Participants	-40 Degrees n=36 Participants
Sagittal balance (C7 to Sacrum plumb)	27 millimeters n=93 Participants	34 millimeters n=4 Participants	26 millimeters n=27 Participants	33 millimeters n=483 Participants	30 millimeters n=36 Participants
Coronal balance	13 millimeters n=93 Participants	23 millimeters n=4 Participants	19 millimeters n=27 Participants	14 millimeters n=483 Participants	18 millimeters n=36 Participants
Pelvic Incidence-Lumbar Lordosis Mismatch	14 Degrees n=93 Participants	25 Degrees n=4 Participants	15 Degrees n=27 Participants	13 Degrees n=483 Participants	16 Degrees n=36 Participants
Education Less than high school	1 Participants n=93 Participants	4 Participants n=4 Participants	1 Participants n=27 Participants	3 Participants n=483 Participants	9 Participants n=36 Participants
Education High school diploma or GED	7 Participants n=93 Participants	5 Participants n=4 Participants	26 Participants n=27 Participants	38 Participants n=483 Participants	76 Participants n=36 Participants
Education Technical or associate's degree	8 Participants n=93 Participants	11 Participants n=4 Participants	18 Participants n=27 Participants	13 Participants n=483 Participants	50 Participants n=36 Participants
Education Bachelor's degree	7 Participants n=93 Participants	6 Participants n=4 Participants	28 Participants n=27 Participants	31 Participants n=483 Participants	72 Participants n=36 Participants
Education Graduate degree	7 Participants n=93 Participants	7 Participants n=4 Participants	39 Participants n=27 Participants	26 Participants n=483 Participants	79 Participants n=36 Participants
Income per yer <$20,000	1 Participants n=93 Participants	2 Participants n=4 Participants	6 Participants n=27 Participants	8 Participants n=483 Participants	17 Participants n=36 Participants
Income per yer $20,000-39,999	1 Participants n=93 Participants	5 Participants n=4 Participants	11 Participants n=27 Participants	14 Participants n=483 Participants	31 Participants n=36 Participants
Income per yer $40,000-74,999	9 Participants n=93 Participants	10 Participants n=4 Participants	15 Participants n=27 Participants	26 Participants n=483 Participants	60 Participants n=36 Participants
Income per yer $75,000+	12 Participants n=93 Participants	13 Participants n=4 Participants	61 Participants n=27 Participants	51 Participants n=483 Participants	137 Participants n=36 Participants
Income per yer Did not report	7 Participants n=93 Participants	3 Participants n=4 Participants	19 Participants n=27 Participants	12 Participants n=483 Participants	41 Participants n=36 Participants
Smoking history Current smoker	1 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants	7 Participants n=483 Participants	17 Participants n=36 Participants
Smoking history Former smoker	11 Participants n=93 Participants	13 Participants n=4 Participants	31 Participants n=27 Participants	32 Participants n=483 Participants	87 Participants n=36 Participants
Smoking history Never	18 Participants n=93 Participants	17 Participants n=4 Participants	75 Participants n=27 Participants	72 Participants n=483 Participants	182 Participants n=36 Participants
Body Mass Index	28 units on a scale n=93 Participants	25 units on a scale n=4 Participants	26 units on a scale n=27 Participants	25 units on a scale n=483 Participants	26 units on a scale n=36 Participants
Osteopenia/Osteoporosis None/Does not apply	11 Participants n=93 Participants	11 Participants n=4 Participants	42 Participants n=27 Participants	48 Participants n=483 Participants	112 Participants n=36 Participants
Osteopenia/Osteoporosis t-score -1 to -1.5	12 Participants n=93 Participants	11 Participants n=4 Participants	32 Participants n=27 Participants	20 Participants n=483 Participants	75 Participants n=36 Participants
Osteopenia/Osteoporosis t-score -1.6 to -2.4	6 Participants n=93 Participants	7 Participants n=4 Participants	29 Participants n=27 Participants	33 Participants n=483 Participants	75 Participants n=36 Participants
Osteopenia/Osteoporosis t-score -2.5 or worse (or vertebral compression fx	1 Participants n=93 Participants	4 Participants n=4 Participants	9 Participants n=27 Participants	10 Participants n=483 Participants	24 Participants n=36 Participants
Hypertension No	16 Participants n=93 Participants	17 Participants n=4 Participants	70 Participants n=27 Participants	68 Participants n=483 Participants	171 Participants n=36 Participants
Hypertension Yes, controlled with diet/exercise	1 Participants n=93 Participants	0 Participants n=4 Participants	4 Participants n=27 Participants	4 Participants n=483 Participants	9 Participants n=36 Participants
Hypertension Yes, controlled w/medication	13 Participants n=93 Participants	16 Participants n=4 Participants	37 Participants n=27 Participants	39 Participants n=483 Participants	105 Participants n=36 Participants
Hypertension Yes, poorly controlled w/medication	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants
Diabetes No	29 Participants n=93 Participants	29 Participants n=4 Participants	108 Participants n=27 Participants	106 Participants n=483 Participants	272 Participants n=36 Participants
Diabetes Yes, controlled with diet	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	2 Participants n=483 Participants	2 Participants n=36 Participants
Diabetes Yes, controlled with oral hypoglycemics	0 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants	2 Participants n=483 Participants	9 Participants n=36 Participants
Diabetes Yes, insulin dependent	1 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	3 Participants n=36 Participants
Depression/Anxiety/Psychiatric Disorder	11 Participants n=93 Participants	9 Participants n=4 Participants	35 Participants n=27 Participants	22 Participants n=483 Participants	77 Participants n=36 Participants
Duration of back symptoms	36 Months n=93 Participants	96 Months n=4 Participants	12 Months n=27 Participants	24 Months n=483 Participants	24 Months n=36 Participants
Duration of leg symptoms	3 Months n=93 Participants	0 Months n=4 Participants	0 Months n=27 Participants	0 Months n=483 Participants	0 Months n=36 Participants

PRIMARY outcome

Timeframe: Baseline, 2-year

Population: All randomized participants were included in analysis.

Outcome measures

Outcome measures
Measure	Randomized Surgical Intervention n=30 Participants Patients consenting to randomization and assigned to Surgical intervention: Surgical intervention as appropriate for adults with symptomatic lumbar scoliosis	Randomized Non-Operative Intervention n=33 Participants 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.
Scoliosis Research Society Quality of Life Questionnaire (SRS QOL) Subscore	0.5 score on a scale Interval 0.3 to 0.8	0.5 score on a scale Interval 0.2 to 0.7

PRIMARY outcome

Timeframe: Baseline, 2-year

Population: All Observational participants were included. Crossover participants provided data in both treatment arms.

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.

Outcome measures

Outcome measures
Measure	Randomized Surgical Intervention n=125 Participants Patients consenting to randomization and assigned to Surgical intervention: Surgical intervention as appropriate for adults with symptomatic lumbar scoliosis	Randomized Non-Operative Intervention n=111 Participants 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.
Scoliosis Research Society Quality of Life (SRS QOL) Subscore	0.7 score on a scale Interval 0.6 to 0.8	0.1 score on a scale Interval 0.0 to 0.2

SECONDARY outcome

Timeframe: Baseline, 2-year

Population: All randomized participants were included.

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.

Outcome measures

Outcome measures
Measure	Randomized Surgical Intervention n=30 Participants Patients consenting to randomization and assigned to Surgical intervention: Surgical intervention as appropriate for adults with symptomatic lumbar scoliosis	Randomized Non-Operative Intervention n=33 Participants 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.
Oswestry Disability Index (ODI) - Randomized Cohort	-13 score on a scale Interval -20.0 to -7.0	-9 score on a scale Interval -15.0 to -4.0

SECONDARY outcome

Timeframe: Baseline, 2-year

Population: All observational participants were included. Crossover participants provided data in both arms.

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.

Outcome measures

Outcome measures
Measure	Randomized Surgical Intervention n=125 Participants Patients consenting to randomization and assigned to Surgical intervention: Surgical intervention as appropriate for adults with symptomatic lumbar scoliosis	Randomized Non-Operative Intervention n=111 Participants 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.
Oswestry Disability Index (ODI)	-15 score on a scale Interval -18.0 to -13.0	-2 score on a scale Interval -5.0 to 0.0

Adverse Events

Surgical Intervention-As Treated AE's Occurring While Patient Was in Surgical Arm

Serious events: 85 serious events

Other events: 128 other events

Deaths: 3 deaths

Non-Operative Intervention-As Treated AE's Occurring While Patient Was on Non Operative Arm

Serious events: 41 serious events

Other events: 70 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Surgical Intervention-As Treated AE's Occurring While Patient Was in Surgical Arm n=171 participants at risk 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.	Non-Operative Intervention-As Treated AE's Occurring While Patient Was on Non Operative Arm n=150 participants at risk 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Surveillance, Epidemiology and End Results (SEER) Cancers	2.9% 5/171 • Number of events 5 • 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	7.3% 11/150 • Number of events 11 • 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
Cardiac disorders Cardiac Events	2.3% 4/171 • Number of events 6 • 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	3.3% 5/150 • Number of events 5 • 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
Gastrointestinal disorders Gastrointestinal Events	4.1% 7/171 • Number of events 7 • 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	6.7% 10/150 • Number of events 14 • 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
Renal and urinary disorders Genitourinary Event	1.8% 3/171 • Number of events 8 • 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	1.3% 2/150 • Number of events 2 • 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
Respiratory, thoracic and mediastinal disorders Pulmonary Event	8.2% 14/171 • Number of events 19 • 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	2.0% 3/150 • Number of events 3 • 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
General disorders Surgeries Unrelated to Adult Symptomatic Lumbar Scoliosis	18.7% 32/171 • Number of events 45 • 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	16.7% 25/150 • Number of events 31 • 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
General disorders Miscellaneous SAE	8.8% 15/171 • Number of events 17 • 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	2.7% 4/150 • Number of events 6 • 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
Musculoskeletal and connective tissue disorders Adult Lumbar Scoliosis Events	18.7% 32/171 • Number of events 66 • 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	0.67% 1/150 • Number of events 1 • 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
Vascular disorders Circulatory Disorders	2.9% 5/171 • Number of events 5 • 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	3.3% 5/150 • Number of events 5 • 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

Other adverse events

Additional Information

Keith H. Bridwell, MD

Washington University

Phone: 314-747-2655

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Surgical Intervention-As Treated AE's Occurring While Patient Was in Surgical Arm n=171 participants at risk 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.	Non-Operative Intervention-As Treated AE's Occurring While Patient Was on Non Operative Arm n=150 participants at risk 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Surveillance, Epidemiology and End Results (SEER) Cancers	2.9% 5/171 • Number of events 5 • 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	7.3% 11/150 • Number of events 11 • 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
Cardiac disorders Cardiac Events	2.3% 4/171 • Number of events 6 • 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	3.3% 5/150 • Number of events 5 • 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
Gastrointestinal disorders Gastrointestinal Events	4.1% 7/171 • Number of events 7 • 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	6.7% 10/150 • Number of events 14 • 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
Renal and urinary disorders Genitourinary Event	1.8% 3/171 • Number of events 8 • 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	1.3% 2/150 • Number of events 2 • 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
Respiratory, thoracic and mediastinal disorders Pulmonary Event	8.2% 14/171 • Number of events 19 • 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	2.0% 3/150 • Number of events 3 • 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
General disorders Surgeries Unrelated to Adult Symptomatic Lumbar Scoliosis	18.7% 32/171 • Number of events 45 • 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	16.7% 25/150 • Number of events 31 • 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
General disorders Miscellaneous SAE	8.8% 15/171 • Number of events 17 • 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	2.7% 4/150 • Number of events 6 • 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
Musculoskeletal and connective tissue disorders Adult Lumbar Scoliosis Events	18.7% 32/171 • Number of events 66 • 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	0.67% 1/150 • Number of events 1 • 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
Vascular disorders Circulatory Disorders	2.9% 5/171 • Number of events 5 • 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	3.3% 5/150 • Number of events 5 • 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