A Multicenter Prospective Study of Quality of Life in Adult Scoliosis - Full Text View

Sponsors and Collaborators:	Washington University School of Medicine National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Emory University New York University School of Medicine University of Virginia University of Louisville Dartmouth-Hitchcock Medical Center
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00854828

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 as appropriate for adults with symptomatic lumbar scoliosis Other: Non operative intervention

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter Prospective Study of Quality of Life in Adult Scoliosis

Resource links provided by NLM:

MedlinePlus related topics: Scoliosis Surgery

U.S. FDA Resources

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, 12, 18, 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, 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 ]

Estimated Enrollment:	300
Study Start Date:	July 2009
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Surgical Intervention: Active Comparator	Procedure: Surgical intervention as appropriate for adults with symptomatic lumbar scoliosis Surgical intervention as appropriate for adults with symptomatic lumbar scoliosis
Non-Surgical Intervention: Active Comparator	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:

Adults ages 40-80 years of age
Double Major or Thoracolumbar/lumbar scoliosis with minimum Cobb angle of 30 degrees
Oswestry score > 19 or SRS score <4.0 in domains of pain, activity &/or appearance.

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 (greater than Grade 2)
Prior thoracic or multiple level lumbar laminectomy or decompression [single 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 less than -3.0 at hip or lumbar spine
Neuromuscular scoliosis (e.g., spinal muscular atrophy, cerebral palsy, Parkinson's Disease)
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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Washington University ( Keith Bridwell, MD )
Study ID Numbers:	R01AR055176-01A2
Study First Received:	March 2, 2009
Last Updated:	March 2, 2009
ClinicalTrials.gov Identifier:	NCT00854828 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:

Adults ages 40-80 years of age
Double Major or Thoracolumbar/lumbar scoliosis with minimum Cobb angle of 30 degrees
Oswestry score > 19 or SRS score <4.0 in domains of pain, activity &/or appearance.
Must be healthy enough to undergo surgical intervention

Study placed in the following topic categories:

Spinal Diseases
Scoliosis
Musculoskeletal Diseases
Quality of Life

Pain
Healthy
Bone Diseases

Additional relevant MeSH terms:

Spinal Diseases
Scoliosis
Spinal Curvatures
Musculoskeletal Diseases
Bone Diseases

ClinicalTrials.gov processed this record on September 11, 2009