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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
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', Montreal University
Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00854828
First received: March 2, 2009
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

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).


Condition Intervention
Scoliosis
Procedure: Surgical intervention
Other: Non operative intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter Prospective Study of Quality of Life in Adult Scoliosis

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Scoliosis Research Society Quality of Life Questionnaire [ Time Frame: baseline and post intervention at months 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Oswestry Disability Index [ Time Frame: baseline & post-intervention at months 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48 ] [ Designated as safety issue: No ]
  • Radiographic measures [ Time Frame: baseline and post-intervention at year 1, 2, 3, 4 ] [ Designated as safety issue: No ]
  • Patient follow up documentation [ Time Frame: Post intervention at months 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: January 2010
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Surgical Intervention Procedure: Surgical intervention
Surgical intervention as appropriate for adults with symptomatic lumbar scoliosis
Active Comparator: Non-Surgical Intervention Other: Non operative intervention
Non operative intervention as appropriate for treatment of adults with symptomatic lumbar scoliosis such as: injections, medications, physical therapy, etc.

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

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00854828

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Maryland
Maryland Spine Center
Baltimore, Maryland, United States, 21212
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, New York
New York University
New York City, New York, United States, 10010
Hospital for Special Surgery
NYC, New York, United States, 10021
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Canada, Quebec
Hopital du Sacre'
Montreal, Quebec, Canada, HrJ 1C5
Sponsors and Collaborators
Washington University School of Medicine
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', Montreal University
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: Keith H Bridwell, MD Washington University Early Recognition Center
Study Director: Jon Lurie, MD Dartmouth-Hitchcock Medical Center
Study Director: Christopher Shaffrey, MD University of Virginia
Study Director: James Weinstein, DO Dartmouth-Hitchcock Medical Center
  More Information

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00854828     History of Changes
Other Study ID Numbers: R01AR055176-01A2
Study First Received: March 2, 2009
Last Updated: July 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Adults 40-80 y/o
Symptomatic Thoracolumbar/lumbar scoliosis w/min Cobb of 30 degrees
Must be considered healthy enough for surgical intervention even if participant is not assigned to or does not select surgical intervention.

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 26, 2014