A Multicenter Prospective Study of Quality of Life in Adult Scoliosis

NCT00854828 | Completed Results DMC

• 2 other identifiers: R01AR055176-01A2R01AR055176
• Study Type: interventional
• Target: 286
• Locations: 2 countries
• Sites: 9

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.

Conditions

Scoliosis

Keywords

Symptomatic 40-80 y/o w/lumbar Cobb of 30 degrees; All Participants must be reasonable surgical candidate at enrollment

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline, 2-year

• 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.

  Baseline, 2-year

Secondary Outcomes (2)

• Oswestry Disability Index (ODI) - Randomized Cohort

  Baseline, 2-year

• Oswestry Disability Index (ODI)

  Baseline, 2-year

Study Arms (2)

Surgical Intervention

ACTIVE COMPARATOR

Procedure: Surgical intervention

Non-Operative Intervention

ACTIVE COMPARATOR

Other: Non-operative intervention

Interventions

Surgical intervention PROCEDURE

Surgical intervention as appropriate for adults with symptomatic lumbar scoliosis

Surgical Intervention

Non-operative intervention OTHER

Non operative intervention as appropriate for treatment of adults with symptomatic lumbar scoliosis such as: injections, medications, physical therapy, etc.

Non-Operative Intervention

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator
• Northwestern University: collaborator
• New York University: collaborator
• University of Virginia: collaborator
• University of Louisville: collaborator
• Maryland Spine Center: collaborator
• Hospital for Special Surgery, New York: collaborator
• University Health Network, Toronto: collaborator
• Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal: collaborator
• Dartmouth College: collaborator

Study Sites (9)

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Maryland Spine Center

Baltimore, Maryland, 21212, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

New York University

New York, New York, 10010, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Hopital du Sacre'

Montreal, Quebec, HrJ 1C5, Canada

Location

Related Publications (2)

• Smith JS, Kelly MP, Yanik EL, Baldus CR, Pham V, Ben-Israel D, Lurie JD, Edwards C, Glassman SD, Lenke LG, Buchowski JM, Carreon LY, Crawford CH 3rd, Lewis SJ, Koski T, Lafage V, Gupta MC, Kim HJ, Ames CP, Bess S, Schwab FJ, Shaffrey CI, Bridwell KH. Operative vs Nonoperative Treatment for Adult Symptomatic Lumbar Scoliosis at 8-Year Follow-Up: A Nonrandomized Clinical Trial. JAMA Surg. 2025 Jun 1;160(6):634-644. doi: 10.1001/jamasurg.2025.0496.

  PMID: 40172880 DERIVED

• 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.

  PMID: 35428916 DERIVED

MeSH Terms

Conditions

Scoliosis

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Keith H. Bridwell, MD
• Organization: Washington University

bridwellk@wustl.edu

314-747-2655

Study Officials

• Keith H Bridwell, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Jon Lurie, MD

  Dartmouth-Hitchcock Medical Center

  STUDY DIRECTOR

• Christopher Shaffrey, MD

  University of Virginia

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There were 2 cohorts: Randomized and Observational, each with an operative and non-operative arm.

Study Record Dates

• First Submitted: March 2, 2009
• First Posted: March 3, 2009
• Study Start: April 1, 2010
• Primary Completion: February 28, 2017
• Study Completion: February 28, 2017
• Last Updated: September 14, 2021
• Results First Posted: September 14, 2021

Record last verified: 2021-08

Locations

US (7); CA (2)