search
Back to results

A Multicenter Prospective Study of Quality of Life in Adult Scoliosis (ASLS)

Primary Purpose

Scoliosis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Surgical intervention
Non-operative intervention
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scoliosis focused on measuring Symptomatic 40-80 y/o w/lumbar Cobb of 30 degrees, All Participants must be reasonable surgical candidate at enrollment

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern University
  • University of Louisville
  • Maryland Spine Center
  • Washington University
  • New York University
  • Hospital for Special Surgery
  • University of Virginia
  • Toronto Western Hospital
  • Hopital du Sacre'

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Surgical Intervention

Non-Operative Intervention

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 2, 2009
Last Updated
September 10, 2021
Sponsor
Washington University School of Medicine
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, Hopital du Sacre-Coeur de Montreal, Dartmouth College
search

1. Study Identification

Unique Protocol Identification Number
NCT00854828
Brief Title
A Multicenter Prospective Study of Quality of Life in Adult Scoliosis
Acronym
ASLS
Official Title
A Multicenter Prospective Study of Quality of Life in Adult Scoliosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
April 2010 (Actual)
Primary Completion Date
February 28, 2017 (Actual)
Study Completion Date
February 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
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, Hopital du Sacre-Coeur de Montreal, Dartmouth College

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis
Keywords
Symptomatic 40-80 y/o w/lumbar Cobb of 30 degrees, All Participants must be reasonable surgical candidate at enrollment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There were 2 cohorts: Randomized and Observational, each with an operative and non-operative arm.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
286 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgical Intervention
Arm Type
Active Comparator
Arm Title
Non-Operative Intervention
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Surgical intervention
Intervention Description
Surgical intervention as appropriate for adults with symptomatic lumbar scoliosis
Intervention Type
Other
Intervention Name(s)
Non-operative intervention
Intervention Description
Non operative intervention as appropriate for treatment of adults with symptomatic lumbar scoliosis such as: injections, medications, physical therapy, etc.
Primary Outcome Measure Information:
Title
Scoliosis Research Society Quality of Life Questionnaire (SRS QOL) Subscore
Description
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
Title
Scoliosis Research Society Quality of Life (SRS QOL) Subscore
Description
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
Secondary Outcome Measure Information:
Title
Oswestry Disability Index (ODI) - Randomized Cohort
Description
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
Title
Oswestry Disability Index (ODI)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith H Bridwell, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jon Lurie, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Christopher Shaffrey, MD
Organizational Affiliation
University of Virginia
Official's Role
Study Director
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Maryland Spine Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21212
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Hopital du Sacre'
City
Montreal
State/Province
Quebec
ZIP/Postal Code
HrJ 1C5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35428916
Citation
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.
Results Reference
derived

Learn more about this trial

A Multicenter Prospective Study of Quality of Life in Adult Scoliosis

We'll reach out to this number within 24 hrs