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Completed

NCT Number: NCT01880164

Cost Effectiveness of Nonoperative Management for Adult Spinal Deformity

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

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California - Davis, Sacramento, California, United States

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About this study

  • Identify disease burden associated with adult spinal deformity (ASD) using quality adjusted life year (QALY) analysis.
  • Identify disease burden of specific demographic and radiographic features associated with ASD.
  • Compare disease burden of ASD to other musculoskeletal and non-musculoskeletal diseases.
  • Identify efficacy of specific nonoperative treatment modalities to treat ASD and identify specific clinical and radiographic features of ASD responsive to nonoperative treatment modalities.
  • Compare QALY and ICER values for different ASD nonoperative treatment modalities to previously established QALY and ICER for values for operative and nonoperative treatment modalities for degenerative hip and knee disease, coronary artery disease, insulin dependent diabetes, and hypertension.
  • Evaluate the cost and work hours associated with data collection and minimum 85% patient follow up.
  • Evaluate patient characteristics associated with poor patient compliance for study follow up including demographic, radiographic and HRQOL values and for reasons for cross-over to operative treatment for ASD.
  • Establish standardized data collection methodology for economic based outcome studies based upon patient demographics and HRQOL values.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Patient unwilling to commit to monthly phone interviews or completion of necessary questionnaires or inability to return for defined follow up time points. Patients unwilling to comply with study protocol will not be offered enrollment into the study, regardless of meeting inclusion criteria.

Treatment and study plan

Primary outcomes

  1. Oswestry Disability Index (ODI)

    Time frame: Initial visit and six months post enrollment

    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.

Secondary outcomes

  1. Radiographs

    Time frame: Initial visit (Day 1)

    Coronal and sagittal radiographic views of the spine obtained to assess coronal curvature and sagittal balance.

Other outcomes

  1. SRS22r

    Time frame: Initial (Day1) and six months post enrollment

    Assess pain, function, self image, and mental health.

  2. EQ5D-3L

    Time frame: Initial (Day1) and six months post enrollment

    Assess health state (best imaginable vs worst imaginable).

  3. Work Productivity and Activity Impairment (WPAI:SHP)

    Time frame: Initial (Day1) and six months post enrollment

    Assess ability to work and perform regular activities as relates to spinal deformity.

  4. NRS

    Time frame: Initial (Day1) and six months post enrollment

    Assess back and leg pain.

  5. Resource Utilization (RRU)

    Time frame: Initial clinic visit (Day1) , Phone interviews at 1, 2, 3, 4, and 5 months, and 6 months clinic visit

    Document nonoperative treatment modalities, such as observation only, pain medicine, physical therapy, chiropractic care, injections, diagnostic radiology, emergency visits, and other therapies. Analysis of this data will determine cost associated with nonoperative care for adult spinal disorders.

Sponsors and collaborators

Lead sponsor

Shay Bess

Other

Collaborators

  • DePuy Spine
  • Medtronic

Registry information

Official study title

Cost Effectiveness of Nonoperative Management for Adult Spinal Deformity Associated With Low Grade Scoliosis: A Prospective Pilot Study to Evaluate Disease Burden and Longitudinal Study Feasibility

Acronym: HEO

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 18, 2013
Registry last updated
Apr 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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