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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00854828
Recruitment Status : Completed
First Posted : March 3, 2009
Results First Posted : September 14, 2021
Last Update Posted : September 14, 2021
Sponsor:
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
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE March 2, 2009
First Posted Date  ICMJE March 3, 2009
Results First Submitted Date  ICMJE June 2, 2021
Results First Posted Date  ICMJE September 14, 2021
Last Update Posted Date September 14, 2021
Actual Study Start Date  ICMJE April 2010
Actual Primary Completion Date February 28, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2021)
  • Scoliosis Research Society Quality of Life Questionnaire (SRS QOL) Subscore [ Time Frame: Baseline, 2-year ]
    Change was calculated as the SRS QOL Subscore value at 2-year minus the value at Baseline for Randomized Cohort (Intent-to-Treat analysis). SRS QOL Subscore value range is 1 to 5, where 5 is the best score and 1 is the worst score possible.
  • Scoliosis Research Society Quality of Life (SRS QOL) Subscore [ Time Frame: Baseline, 2-year ]
    Change was calculated as the SRS QOL Subscore value at 2-year as-treated follow-up minus the value at Baseline in the Observational cohort. SRS QOL Subscore value range is 1 to 5, where 5 is the best score and 1 is the worst score possible.
Original Primary Outcome Measures  ICMJE
 (submitted: March 2, 2009)
Scoliosis Research Society Quality of Life Questionnaire [ Time Frame: baseline and post intervention at months 3, 6, 12, 18, 24, 30, 36, 42, 48 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2021)
  • Oswestry Disability Index (ODI) - Randomized Cohort [ Time Frame: 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) [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2009)
  • Oswestry Disability Index [ Time Frame: baseline & post-intervention at months 3, 6, 12, 18, 24, 30, 36, 42, 48 ]
  • Radiographic measures [ Time Frame: baseline and post-intervention at year 1, 2, 3, 4 ]
  • Patient follow up documentation [ Time Frame: Post intervention at months 3, 6, 12, 18, 24, 30, 36, 42, 48 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multicenter Prospective Study of Quality of Life in Adult Scoliosis
Official Title  ICMJE A Multicenter Prospective Study of Quality of Life in Adult Scoliosis
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
There were 2 cohorts: Randomized and Observational, each with an operative and non-operative arm.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Scoliosis
Intervention  ICMJE
  • Procedure: Surgical intervention
    Surgical intervention as appropriate for adults with symptomatic lumbar scoliosis
  • Other: Non-operative intervention
    Non operative intervention as appropriate for treatment of adults with symptomatic lumbar scoliosis such as: injections, medications, physical therapy, etc.
Study Arms  ICMJE
  • Active Comparator: Surgical Intervention
    Intervention: Procedure: Surgical intervention
  • Active Comparator: Non-Operative Intervention
    Intervention: Other: Non-operative intervention
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 10, 2021)
286
Original Estimated Enrollment  ICMJE
 (submitted: March 2, 2009)
300
Actual Study Completion Date  ICMJE February 28, 2017
Actual Primary Completion Date February 28, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00854828
Other Study ID Numbers  ICMJE R01AR055176-01A2( U.S. NIH Grant/Contract )
R01AR055176 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Washington University School of Medicine
Original Responsible Party Keith Bridwell, MD, Washington University
Current Study Sponsor  ICMJE Washington University School of Medicine
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • 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
Investigators  ICMJE
Principal Investigator: Keith H Bridwell, MD Washington University School of Medicine
Study Director: Jon Lurie, MD Dartmouth-Hitchcock Medical Center
Study Director: Christopher Shaffrey, MD University of Virginia
PRS Account Washington University School of Medicine
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP