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Trial record 1 of 108 for:    ADULT SCOLIOSIS
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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

March 2, 2009
July 7, 2014
January 2010
September 2016   (final data collection date for primary outcome measure)
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 ]
Scoliosis Research Society Quality of Life Questionnaire [ Time Frame: baseline and post intervention at months 3, 6, 12, 18, 24, 30, 36, 42, 48 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00854828 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Oswestry Disability Index [ Time Frame: baseline & post-intervention at months 3, 6, 12, 18, 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, 12, 18, 24, 30, 36, 42, 48 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Multicenter Prospective Study of Quality of Life in Adult Scoliosis
A Multicenter Prospective Study of Quality of Life in Adult Scoliosis

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).

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Scoliosis
  • 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.
  • Active Comparator: Surgical Intervention
    Intervention: Procedure: Surgical intervention
  • Active Comparator: Non-Surgical Intervention
    Intervention: Other: Non operative intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
300
September 2016
September 2016   (final data collection date for primary outcome measure)

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
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00854828
R01AR055176-01A2
Yes
Washington University School of Medicine
Washington University School of Medicine
  • 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', Montreal University
  • Dartmouth-Hitchcock Medical Center
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
Study Director: James Weinstein, DO Dartmouth-Hitchcock Medical Center
Washington University School of Medicine
July 2014

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