A Multicenter Prospective Study of Quality of Life in Adult Scoliosis

Scoliosis Clinical Trial

— ASLS  

Official title:

A Multicenter Prospective Study of Quality of Life in Adult Scoliosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00854828
• Other study ID #: R01AR055176-01A2
• Secondary ID: R01AR055176
• Status: Completed
• Phase: N/A
• Start date: April 2010
• Est. completion date: February 28, 2017

Study information

• Verified date: August 2021
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: February 28, 2017
• Est. primary completion date: February 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Scoliosis

Intervention

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.

Locations

Country	Name	City	State
Canada	Hopital du Sacre'	Montreal	Quebec
Canada	Toronto Western Hospital	Toronto	Ontario
United States	Maryland Spine Center	Baltimore	Maryland
United States	University of Virginia	Charlottesville	Virginia
United States	Northwestern University	Chicago	Illinois
United States	University of Louisville	Louisville	Kentucky
United States	Hospital for Special Surgery	New York	New York
United States	New York University	New York	New York
United States	Washington University	Saint Louis	Missouri

Sponsors (11)

Lead Sponsor	Collaborator
Washington University School of Medicine	Dartmouth College, Hopital du Sacre-Coeur de Montreal, Hospital for Special Surgery, New York, Maryland Spine Center, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), New York University, Northwestern University, University Health Network, Toronto, University of Louisville, University of Virginia

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Oswestry Disability Index (ODI) - Randomized Cohort	Change was calculated as the ODI score at 2-year minus the value at Baseline in Randomized Cohort (intent-to-treat analysis).; ODI score range is 0 to 100, where 0 is the best score and 100 is the worst score possible.	Baseline, 2-year
Secondary	Oswestry Disability Index (ODI)	Change was calculated as the ODI score at 2-year as treated follow-up minus the value at baseline.; ODI score range is 0 to 100, where 0 is the best score and 100 is the worst score possible.	Baseline, 2-year