Cost Effectiveness of Nonoperative Management for Adult Spinal Deformity

NCT01880164 | Completed

• 1 other identifier: 2108
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 10

Brief Summary

Quantify the efficacy and cost of nonoperative treatment modalities used for adult spinal deformity.

Conditions

Spinal Deformity

Keywords

Scoliosis; Kyphosis; Sagittal plane deformity

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Index (ODI)

  This questionnaire has been designed to provide information as to how back pain affects ability to manage in everyday life. Score must be equal to or greater than 30 for eligibility to enroll.

  Initial visit and six months post enrollment

Secondary Outcomes (1)

• Radiographs

  Initial visit (Day 1)

Other Outcomes (5)

• SRS22r

  Initial (Day1) and six months post enrollment

• EQ5D-3L

  Initial (Day1) and six months post enrollment

• Work Productivity and Activity Impairment (WPAI:SHP)

  Initial (Day1) and six months post enrollment

Study Arms (1)

Nonoperative

Adult spinal deformity (degenerative or idiopathic) with an ODI of 30 or greater

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult spinal deformity patients

You may qualify if:

• Age 40-75 years of age at the time of enrollment.
• ODI ≥30
• Adult degenerative or idiopathic lumbar scoliosis 10-40° as measured by the Cobb angle technique
• Sagittal plane deformity by SRS Schwab classification with at least one modifier ++ or two modifiers + and associated coronal cobb of at least 10 degrees

You may not qualify if:

• Adult degenerative or idiopathic scoliosis with a curvature of the spine measuring \<10 degrees or \>40 degrees
• Diagnosis of scoliosis other than degenerative or idiopathic (i.e. neuromuscular, congenital, etc.)
• Cardiopulmonary disease or comorbidities that preclude surgical intervention
• Patient not deemed surgical candidate by treating surgeon

Sponsors & Collaborators

• Shay Bess: lead
• DePuy Spine: collaborator
• Medtronic: collaborator

Study Sites (10)

University of California - Davis

Sacramento, California, 95817, United States

Location

University of California - San Francisco Medical Center

San Francisco, California, 94143, United States

Location

Rocky Mountain Scoliosis and Spine

Denver, Colorado, 80205, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Norton Leatherman Spine Center

Louisville, Kentucky, 40202, United States

Location

Washington University at St. Louis

St Louis, Missouri, 63110, United States

Location

NYU Hospital for Joint Diseases

New York, New York, 10010, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97239, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (35)

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MeSH Terms

Conditions

Scoliosis; Kyphosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Shay Bess, MD

  Rocky Mountain Scoliosis and Spine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: President, ISSGF

Study Record Dates

• First Submitted: June 14, 2013
• First Posted: June 18, 2013
• Study Start: June 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: April 1, 2017
• Last Updated: April 6, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)