Spinal DeformityHEONCT01880164

Cost Effectiveness of Nonoperative Management for Adult Spinal Deformity

An observational study of Spinal Deformity, run by Shay Bess at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Quantify the efficacy and cost of nonoperative treatment modalities used for adult spinal deformity. Read more about this study

Who is it for?: Ages 40 to 75 years
Conditions the study is for: Spinal Deformity
How many people: 21 participants
Where: 10 sitesUnited States
Study dates: Jun 2015to Apr 2017
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Adult spinal deformity patients

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

University of Virginia
Charlottesville, Virginia, 22908
Rocky Mountain Scoliosis and Spine
Denver, Colorado, 80205
University of Kansas Medical Center
Kansas City, Kansas, 66160
Norton Leatherman Spine Center
Louisville, Kentucky, 40202
NYU Hospital for Joint Diseases
New York, New York, 10010
Hospital for Special Surgery
New York, New York, 10021
Oregon Health Sciences University
Portland, Oregon, 97239
University of California - Davis
Sacramento, California, 95817
University of California - San Francisco Medical Center
San Francisco, California, 94143
Washington University at St. Louis
St Louis, Missouri, 63110

Other trials in United States

About this study

Official 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

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

Read the detailed description

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.

Conditions: Spinal Deformity
Keywords: Scoliosis, Kyphosis, Sagittal plane deformity
Medical subject headings: Scoliosis, Kyphosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01880164
Study group	Role	What they receive
Nonoperative		Adult spinal deformity (degenerative or idiopathic) with an ODI of 30 or greater

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Initial visit and six months post enrollment

Secondary outcomes (1)

Radiographs
Coronal and sagittal radiographic views of the spine obtained to assess coronal curvature and sagittal balance.
Measured: Initial visit (Day 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2015Apr 2017

First posted18 Jun 2013 (estimated)
Study startJun 2015
Primary completionJan 2017
Study completionApr 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (35)Papers the sponsor has linked to this study.
Other trials for Spinal DeformityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01880164
Sponsor's protocol ID: 2108
Acronym: HEO
Status last verified: Apr 2017
First submitted: 14 Jun 2013
Last updated: 6 Apr 2017
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Avorn J. Debate about funding comparative-effectiveness research. N Engl J Med. 2009 May 7;360(19):1927-9. doi: 10.1056/NEJMp0902427. No abstract available.
PubMed 19420361
Baldus C, Bridwell KH, Harrast J, Edwards C 2nd, Glassman S, Horton W, Lenke LG, Lowe T, Mardjetko S, Ondra S, Schwab F, Shaffrey C. Age-gender matched comparison of SRS instrument scores between adult deformity and normal adults: are all SRS domains disease specific? Spine (Phila Pa 1976). 2008 Sep 15;33(20):2214-8. doi: 10.1097/BRS.0b013e31817c0466.
PubMed 18794764
Berven S, Deviren V, Demir-Deviren S, Hu SS, Bradford DS. Studies in the modified Scoliosis Research Society Outcomes Instrument in adults: validation, reliability, and discriminatory capacity. Spine (Phila Pa 1976). 2003 Sep 15;28(18):2164-9; discussion 2169. doi: 10.1097/01.BRS.0000084666.53553.D6.
PubMed 14501930
Bonham AC, Rich EC, Davis DA, Longnecker DE, Heinig SJ. Commentary: Putting evidence to work: an expanded research agenda for academic medicine in the era of health care reform. Acad Med. 2010 Oct;85(10):1551-3. doi: 10.1097/ACM.0b013e3181effdbc.
PubMed 20703148
Bridwell KH, Berven S, Glassman S, Hamill C, Horton WC 3rd, Lenke LG, Schwab F, Baldus C, Shainline M. Is the SRS-22 instrument responsive to change in adult scoliosis patients having primary spinal deformity surgery? Spine (Phila Pa 1976). 2007 Sep 15;32(20):2220-5. doi: 10.1097/BRS.0b013e31814cf120.
PubMed 17873814
Bridwell KH, Glassman S, Horton W, Shaffrey C, Schwab F, Zebala LP, Lenke LG, Hilton JF, Shainline M, Baldus C, Wootten D. Does treatment (nonoperative and operative) improve the two-year quality of life in patients with adult symptomatic lumbar scoliosis: a prospective multicenter evidence-based medicine study. Spine (Phila Pa 1976). 2009 Sep 15;34(20):2171-8. doi: 10.1097/BRS.0b013e3181a8fdc8.
PubMed 19752703
Carter OD, Haynes SG. Prevalence rates for scoliosis in US adults: results from the first National Health and Nutrition Examination Survey. Int J Epidemiol. 1987 Dec;16(4):537-44. doi: 10.1093/ije/16.4.537.
PubMed 3501989
Deyo RA, Mirza SK, Martin BI, Kreuter W, Goodman DC, Jarvik JG. Trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. JAMA. 2010 Apr 7;303(13):1259-65. doi: 10.1001/jama.2010.338.
PubMed 20371784
Everett CR, Patel RK. A systematic literature review of nonsurgical treatment in adult scoliosis. Spine (Phila Pa 1976). 2007 Sep 1;32(19 Suppl):S130-4. doi: 10.1097/BRS.0b013e318134ea88.
PubMed 17728680
Garber AM, Tunis SR. Does comparative-effectiveness research threaten personalized medicine? N Engl J Med. 2009 May 7;360(19):1925-7. doi: 10.1056/NEJMp0901355. No abstract available.
PubMed 19420360
Garrison KR, Donell S, Ryder J, Shemilt I, Mugford M, Harvey I, Song F. Clinical effectiveness and cost-effectiveness of bone morphogenetic proteins in the non-healing of fractures and spinal fusion: a systematic review. Health Technol Assess. 2007 Aug;11(30):1-150, iii-iv. doi: 10.3310/hta11300.
PubMed 17669279
Glassman SD, Berven S, Kostuik J, Dimar JR, Horton WC, Bridwell K. Nonsurgical resource utilization in adult spinal deformity. Spine (Phila Pa 1976). 2006 Apr 15;31(8):941-7. doi: 10.1097/01.brs.0000209318.32148.8b.
PubMed 16622386
Glassman SD, Bridwell K, Dimar JR, Horton W, Berven S, Schwab F. The impact of positive sagittal balance in adult spinal deformity. Spine (Phila Pa 1976). 2005 Sep 15;30(18):2024-9. doi: 10.1097/01.brs.0000179086.30449.96.
PubMed 16166889
Glassman SD, Carreon LY, Shaffrey CI, Polly DW, Ondra SL, Berven SH, Bridwell KH. The costs and benefits of nonoperative management for adult scoliosis. Spine (Phila Pa 1976). 2010 Mar 1;35(5):578-82. doi: 10.1097/BRS.0b013e3181b0f2f8.
PubMed 20118843
Glassman SD, Polly DW, Dimar JR, Carreon LY. The cost effectiveness of single-level instrumented posterolateral lumbar fusion at 5 years after surgery. Spine (Phila Pa 1976). 2012 Apr 20;37(9):769-74. doi: 10.1097/BRS.0b013e3181e03099.
PubMed 20489676

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Spinal Deformity trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT01880164
Acronym / sponsor ID: HEO / 2108
Conditions: Spinal Deformity
Keywords: Scoliosis, Kyphosis, Sagittal plane deformity
Study type: Observational
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Shay BessUniversity, hospital or other
Collaborators: DePuy Spine, Medtronic
Study start: Jun 2015
Primary completion: Jan 2017 (actual)
Study completion: Apr 2017 (actual)
First posted: 18 Jun 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Nonoperative	–	–Adult spinal deformity (degenerative or idiopathic) with an ODI of 30 or greater

Who may qualify

Ages: 40 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adult spinal deformity patients

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.

1 secondary outcome

Radiographs
Time frame: Initial visit (Day 1)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
Background: PubMed 19420361Avorn J. Debate about funding comparative-effectiveness research. N Engl J Med. 2009 May 7;360(19):1927-9. doi: 10.1056/NEJMp0902427. No abstract available.
Background: PubMed 18794764Baldus C, Bridwell KH, Harrast J, Edwards C 2nd, Glassman S, Horton W, Lenke LG, Lowe T, Mardjetko S, Ondra S, Schwab F, Shaffrey C. Age-gender matched comparison of SRS instrument scores between adult deformity and normal adults: are all SRS domains disease specific? Spine (Phila Pa 1976). 2008 Sep 15;33(20):2214-8. doi: 10.1097/BRS.0b013e31817c0466.
Background: PubMed 14501930Berven S, Deviren V, Demir-Deviren S, Hu SS, Bradford DS. Studies in the modified Scoliosis Research Society Outcomes Instrument in adults: validation, reliability, and discriminatory capacity. Spine (Phila Pa 1976). 2003 Sep 15;28(18):2164-9; discussion 2169. doi: 10.1097/01.BRS.0000084666.53553.D6.
Background: PubMed 20703148Bonham AC, Rich EC, Davis DA, Longnecker DE, Heinig SJ. Commentary: Putting evidence to work: an expanded research agenda for academic medicine in the era of health care reform. Acad Med. 2010 Oct;85(10):1551-3. doi: 10.1097/ACM.0b013e3181effdbc.
Background: PubMed 17873814Bridwell KH, Berven S, Glassman S, Hamill C, Horton WC 3rd, Lenke LG, Schwab F, Baldus C, Shainline M. Is the SRS-22 instrument responsive to change in adult scoliosis patients having primary spinal deformity surgery? Spine (Phila Pa 1976). 2007 Sep 15;32(20):2220-5. doi: 10.1097/BRS.0b013e31814cf120.
Background: PubMed 19752703Bridwell KH, Glassman S, Horton W, Shaffrey C, Schwab F, Zebala LP, Lenke LG, Hilton JF, Shainline M, Baldus C, Wootten D. Does treatment (nonoperative and operative) improve the two-year quality of life in patients with adult symptomatic lumbar scoliosis: a prospective multicenter evidence-based medicine study. Spine (Phila Pa 1976). 2009 Sep 15;34(20):2171-8. doi: 10.1097/BRS.0b013e3181a8fdc8.
Background: PubMed 3501989Carter OD, Haynes SG. Prevalence rates for scoliosis in US adults: results from the first National Health and Nutrition Examination Survey. Int J Epidemiol. 1987 Dec;16(4):537-44. doi: 10.1093/ije/16.4.537.
Background: PubMed 20371784Deyo RA, Mirza SK, Martin BI, Kreuter W, Goodman DC, Jarvik JG. Trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. JAMA. 2010 Apr 7;303(13):1259-65. doi: 10.1001/jama.2010.338.
Background: PubMed 17728680Everett CR, Patel RK. A systematic literature review of nonsurgical treatment in adult scoliosis. Spine (Phila Pa 1976). 2007 Sep 1;32(19 Suppl):S130-4. doi: 10.1097/BRS.0b013e318134ea88.
Background: PubMed 19420360Garber AM, Tunis SR. Does comparative-effectiveness research threaten personalized medicine? N Engl J Med. 2009 May 7;360(19):1925-7. doi: 10.1056/NEJMp0901355. No abstract available.
Background: PubMed 17669279Garrison KR, Donell S, Ryder J, Shemilt I, Mugford M, Harvey I, Song F. Clinical effectiveness and cost-effectiveness of bone morphogenetic proteins in the non-healing of fractures and spinal fusion: a systematic review. Health Technol Assess. 2007 Aug;11(30):1-150, iii-iv. doi: 10.3310/hta11300.
Background: PubMed 16622386Glassman SD, Berven S, Kostuik J, Dimar JR, Horton WC, Bridwell K. Nonsurgical resource utilization in adult spinal deformity. Spine (Phila Pa 1976). 2006 Apr 15;31(8):941-7. doi: 10.1097/01.brs.0000209318.32148.8b.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shay Bess, MD principal investigator

Rocky Mountain Scoliosis and Spine

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Spinal Deformity, run by Shay Bess at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oswestry Disability Index (ODI) (time frame: Initial visit and six months post enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01880164, which also lists 35 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2017.