A Multicenter Prospective Study of Quality of Life in Adult Scoliosis

NCT ID: NCT00854828

Last Updated: 2021-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 286 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2017-02-28

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

Conditions

Scoliosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Surgical Intervention

Group Type: ACTIVE_COMPARATOR

Surgical intervention

Intervention Type: PROCEDURE

Surgical intervention as appropriate for adults with symptomatic lumbar scoliosis

Non-Operative Intervention

Group Type: ACTIVE_COMPARATOR

Non-operative intervention

Intervention Type: OTHER

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

Interventions

Surgical intervention

Surgical intervention as appropriate for adults with symptomatic lumbar scoliosis

Intervention Type: PROCEDURE

Non-operative intervention

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: collaborator

New York University

OTHER

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: collaborator

University of Louisville

OTHER

Sponsor Role: collaborator

Maryland Spine Center

OTHER

Sponsor Role: collaborator

Hospital for Special Surgery, New York

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: collaborator

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

OTHER

Sponsor Role: collaborator

Dartmouth College

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Keith H Bridwell, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Jon Lurie, MD

Role: STUDY_DIRECTOR

Dartmouth-Hitchcock Medical Center

Christopher Shaffrey, MD

Role: STUDY_DIRECTOR

University of Virginia

Locations

Northwestern University

Chicago, Illinois, United States

University of Louisville

Louisville, Kentucky, United States

Maryland Spine Center

Baltimore, Maryland, United States

Washington University

St Louis, Missouri, United States

New York University

New York, New York, United States

Hospital for Special Surgery

New York, New York, United States

University of Virginia

Charlottesville, Virginia, United States

Toronto Western Hospital

Toronto, Ontario, Canada

Hopital du Sacre'

Montreal, Quebec, Canada

Countries

United States; Canada

References

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.

Reference Type: DERIVED

PMID: 40172880 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35428916 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

R01AR055176

Identifier Type: NIH

Identifier Source: secondary_id

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R01AR055176-01A2

Identifier Type: NIH

Identifier Source: org_study_id

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