SpondylolisthesisPhase 4SPORTNCT00000409
Spine Patient Outcomes Research Trial (SPORT): Degenerative Spondylolisthesis With Spinal Stenosis
A Phase 4 study testing Decompressive laminectomy, Non-surgical treatments and Fusion--Instrumented in people with Spondylolisthesis and Spinal Stenosis, run by Dartmouth-Hitchcock Medical Center at 13 sites in United States.
Trial summary
This study tests the effectiveness of different treatments for the three most commonly diagnosed conditions of the lower backbone (lumbar spine). The purpose is to learn which of two commonly prescribed treatments (surgery and nonsurgical therapy) works better for specific types of low back pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondylolisthesis, Spinal Stenosis, Low Back Pain
- What is being tested?
- Decompressive laminectomy, Non-surgical treatments and Fusion--Instrumented
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 13 sitesUnited States
- Study dates
- Mar 2000to Apr 2015
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Duration of Symptoms: 12 or more weeks.
- Treatments Tried: Nonsteroidal. anti-inflammatory medical therapy and physical therapy.
- Surgical Screening: Pain in low back, buttocks, or lower extremity that becomes worse with lumbar extension. Must be confirmed by evidence of central or central-lateral compression of the cauda equina by a degenerative lesion of the facet joint, disc, or ligamentum flavum on MRI, computed tomography scans, or myelograms.
- Tests: MRI to confirm diagnosis and level(s).
Who cannot join
- Previous lumbar spine surgery.
- Not a surgical candidate for any of these reasons: Overall health that makes spinal surgery too life-threatening to be an appropriate alternative, patient has improved dramatically with conservative care, or the patient is unable (for any reason) to undergo surgery within 6 months.
- Possible pregnancy.
- Active malignancy: Patients with a history of any invasive malignancy (except nonmelanoma skin cancer) are ineligible unless they have been treated with curative intent AND have not had any clinical signs or symptoms of the malignancy for at least 5 years.
- Current fracture, infection, and/or deformity (greater than 15 degrees of lumbar scoliosis, using Cobb measure technique) of the spine.
- Age less than 18 years.
Show all 10Show fewer
- Cauda equina syndrome or progressive neurologic deficit (usually requiring urgent surgery).
- Unavailability for followup (planning to move, no telephone, etc.) or inability to complete data surveys.
- Symptoms less than 12 weeks.
- Patient currently enrolled in any experimental "spine related" study.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Rush-Presbyterian, St. Luke's Medical Center
Chicago, Illinois, 60612-3833
Case Western Reserve University
Cleveland, Ohio, 44106
Emory University, The Emory Clinic
Decatur, Georgia, 30033
Dartmouth-Hitchcock Medical Center - Spine Center
Lebanon, New Hampshire, 03756
New York University, The Hospital for Joint Diseases
New York, New York, 10003
Hospital for Special Surgery
New York, New York, 10021
Kaiser Permanente Spine Care Program
Oakland, California, 94612
Nebraska Foundation for Spinal Research
Omaha, Nebraska, 68154-4438
Rothman Institute at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107-4216
William Beaumont Hospital
Royal Oak, Michigan, 48073-9952
University of California, San Francisco (UCSF)
San Francisco, California, 94143-0728
Maine Spine & Rehabilitation
Scarborough, Maine, 04074
Washington University
St Louis, Missouri, 63110
About this study
Official title: Spine Patient Outcomes Research Trial (SPORT): A Multicenter Randomized Trial for Degenerative Spondylolisthesis (DS) With Spinal Stenosis (SpS) at L4/L5 Level.
This study tests the effectiveness of different treatments for the three most commonly diagnosed conditions of the lower backbone (lumbar spine). The purpose is to learn which of two commonly prescribed treatments (surgery and nonsurgical therapy) works better for specific types of low back pain.
In this part of the study, we will treat patients with spinal stenosis (a narrowing of spaces in the backbone that results in pressure on the spinal cord and/or nerve roots) caused by degenerative spondylolisthesis (a condition in which one vertebra, or spinal bone, slips forward on another) with either surgery or nonsurgical methods. This study does not cover the cost of treatment.
Read the detailed description
Low back pain is considered one of the most widely experienced health problems in the U.S. and the world. It is the second most frequent condition, after the common cold, for which patients see a physician or lose days from work. Estimated costs to those who are severely disabled from low back pain range from $30-70 billion annually. Rates of spinal surgery in the U.S. have increased sharply over time, and researchers have documented 15-fold geographic variation in rates of these surgeries. In many cases, where one lives and who one sees for the condition appear to determine the rates of surgery. Despite these trends, there is little evidence proving the effectiveness of these therapies over nonsurgical management.
This study will use the National Spine Network to conduct a multicenter, randomized, controlled trial for the three most common diagnostic groups for which spine surgery is performed: lumbar intervertebral disc herniation (IDH), spinal stenosis (SpS), and spinal stenosis secondary to degenerative spondylolisthesis (DS). This arm of the trial will deal with patients from the third diagnostic group. The study will compare the most commonly used standard surgical treatments to the most commonly used standard nonsurgical treatments. We will conduct the study at 12 sites throughout the United States.
The primary endpoint of the study will be changes in health-related quality of life as measured by the SF-36 health status questionnaire. Secondary endpoints will include patient satisfaction with treatment, utility for current health in order to estimate quality-adjusted life years (QALYS) as the measure for cost-effectiveness, resource use, and cost.
We will follow patients at 6 weeks and 3, 6, 12, and 24 months to determine their health status, function, satisfaction, and health care use. We anticipate that we will enroll and randomly allocate a total of 300 study participants in this arm of the trial. We will track an additional observational cohort to assess health and resource outcomes. Enrollment in the Observational cohort has been completed as of February 2003.
We will integrate data from the trial and observational cohorts to formally estimate the cost-effectiveness of surgical versus nonsurgical interventions for IDH, SpS, and DS. The results of this trial will provide, for the first time, scientific evidence as to the relative effectiveness of surgical versus nonsurgical treatment for these three most commonly diagnosed lumbar spine conditions.
- Conditions
- Spondylolisthesis, Spinal Stenosis, Low Back Pain
- Being tested
- Decompressive laminectomy, Non-surgical treatments, Fusion--Instrumented, Fusion-Non-instrumented
- Keywords
- Intervertebral disc herniation (IDH), Degenerative spondylolisthesis (DS), Spinal stenosis (SpS), Low back pain (LBP), Leg pain, Surgical therapy, Randomized study, Multicenter, MRI, Nonsurgical therapy
- Medical subject headings
- Spondylolisthesis, Spinal Stenosis, Low Back Pain, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decompressive laminectomyProcedure or surgery
Removal of the hypertrophic inferior and superior articular facets will be performed when they are intruding upon the midline and causing both central and lateral recess stenosis
Non-surgical treatmentsOther
Active physical therapy modality, Education/Counseling with home exercise instruction, and an NSAID if tolerated. Any non-operative therapies other than these are accepted and collected as data.
Fusion--InstrumentedProcedure or surgery
In addition to decompressive laminectomy, additional bilateral non-instrumented or instrumented, i.e., posterior pedicle fixation, posterolateral fusion with autogenous bone grafting (utilizing iliac crest harvested from between the tables and/or local bone) will be performed between the transverse processes and the lateral portion of the superior facets of the involved levels.
Fusion-Non-instrumentedProcedure or surgery
additional bilateral non-instrumented or instrumented, i.e., posterior pedicle fixation, posterolateral fusion with autogenous bone grafting (utilizing iliac crest harvested from between the tables and/or local bone) will be performed between the transverse processes and the lateral portion of the superior facets of the involved levels.
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Active comparator | Decompressive Laminectomy Fusion-Instrumented Fusion-Non-instrumented Receives: Procedure: Decompressive laminectomy; Other: Non-surgical treatments; Procedure: Fusion--Instrumented; Procedure: Fusion-Non-instrumented |
| Non-surgical intervention | Active comparator | Other. Non-surgical treatments Receives: Other: Non-surgical treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in health-related quality of life as measured by the SF-36 health status questionnaire
Measured: Baseline, 6 wks, 3 and 6 mos, Annually thereafter
Secondary outcomes (4)
Patient satisfaction with treatment
Measured: Baseline, 6 wks, 3 mos, Annually thereafter
utility for current health in order to estimate quality-adjusted life years (QALYS) as the measure for cost effectiveness
Measured: Baseline, 1 yr, 4 yr
resource utilization
Measured: Baseline, 6 wks, 3 and 6 mos, Annually thereafter
cost
Measured: Baseline, 6 wks, 3 and 6 mos, Annually thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startMar 2000
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for SpondylolisthesisStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute for Occupational Safety and Health (NIOSH/CDC), Office of Research on Women's Health (ORWH)
- Responsible party
- Sponsor
- Investigators
- James N. Weinstein, DO, MS, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000409
- Sponsor's protocol ID
- U01 AR45444 NIAMS-004A
- Other IDs
- U01AR045444
- Acronym
- SPORT
- Status last verified
- Aug 2015
- First submitted
- 3 Nov 1999
- Last updated
- 4 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Birkmeyer NJ, Weinstein JN, Tosteson AN, Tosteson TD, Skinner JS, Lurie JD, Deyo R, Wennberg JE. Design of the Spine Patient outcomes Research Trial (SPORT). Spine (Phila Pa 1976). 2002 Jun 15;27(12):1361-72. doi: 10.1097/00007632-200206150-00020.
PubMed 12065987Weinstein JN, Brown PW, Hanscom B, Walsh T, Nelson EC. Designing an ambulatory clinical practice for outcomes improvement: from vision to reality--the Spine Center at Dartmouth-Hitchcock, year one. Qual Manag Health Care. 2000 Winter;8(2):1-20. doi: 10.1097/00019514-200008020-00003.
PubMed 10787504Fanciullo GJ, Hanscom B, Weinstein JN, Chawarski MC, Jamison RN, Baird JC. Cluster analysis classification of SF-36 profiles for patients with spinal pain. Spine (Phila Pa 1976). 2003 Oct 1;28(19):2276-82. doi: 10.1097/01.BRS.0000084880.33281.EB.
PubMed 14520044Lurie JD, Birkmeyer NJ, Weinstein JN. Rates of advanced spinal imaging and spine surgery. Spine (Phila Pa 1976). 2003 Mar 15;28(6):616-20. doi: 10.1097/01.BRS.0000049927.37696.DC.
PubMed 12642771Walsh TL, Hanscom B, Lurie JD, Weinstein JN. Is a condition-specific instrument for patients with low back pain/leg symptoms really necessary? The responsiveness of the Oswestry Disability Index, MODEMS, and the SF-36. Spine (Phila Pa 1976). 2003 Mar 15;28(6):607-15. doi: 10.1097/01.BRS.0000050654.97387.DF.
PubMed 12642770Weinstein JN, Lurie JD, Tosteson TD, Hanscom B, Tosteson AN, Blood EA, Birkmeyer NJ, Hilibrand AS, Herkowitz H, Cammisa FP, Albert TJ, Emery SE, Lenke LG, Abdu WA, Longley M, Errico TJ, Hu SS. Surgical versus nonsurgical treatment for lumbar degenerative spondylolisthesis. N Engl J Med. 2007 May 31;356(22):2257-70. doi: 10.1056/NEJMoa070302.
PubMed 17538085Weinstein JN, Lurie JD, Tosteson TD, Zhao W, Blood EA, Tosteson AN, Birkmeyer N, Herkowitz H, Longley M, Lenke L, Emery S, Hu SS. Surgical compared with nonoperative treatment for lumbar degenerative spondylolisthesis. four-year results in the Spine Patient Outcomes Research Trial (SPORT) randomized and observational cohorts. J Bone Joint Surg Am. 2009 Jun;91(6):1295-304. doi: 10.2106/JBJS.H.00913.
PubMed 19487505Tosteson AN, Tosteson TD, Lurie JD, Abdu W, Herkowitz H, Andersson G, Albert T, Bridwell K, Zhao W, Grove MR, Weinstein MC, Weinstein JN. Comparative effectiveness evidence from the spine patient outcomes research trial: surgical versus nonoperative care for spinal stenosis, degenerative spondylolisthesis, and intervertebral disc herniation. Spine (Phila Pa 1976). 2011 Nov 15;36(24):2061-8. doi: 10.1097/BRS.0b013e318235457b.
PubMed 22048651Abdu WA, Lurie JD, Spratt KF, Tosteson AN, Zhao W, Tosteson TD, Herkowitz H, Longely M, Boden SD, Emery S, Weinstein JN. Degenerative spondylolisthesis: does fusion method influence outcome? Four-year results of the spine patient outcomes research trial. Spine (Phila Pa 1976). 2009 Oct 1;34(21):2351-60. doi: 10.1097/BRS.0b013e3181b8a829.
PubMed 19755935
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spine Patient Outcomes Research Trial (SPORT): A Multicenter Randomized Trial for Degenerative Spondylolisthesis (DS) With Spinal Stenosis (SpS) at L4/L5 Level.
- ClinicalTrials.gov ID
- NCT00000409
- Acronym / sponsor ID
- SPORT / U01 AR45444 NIAMS-004A
- Conditions
- Spondylolisthesis, Spinal Stenosis, Low Back Pain
- Keywords
- Intervertebral disc herniation (IDH), Degenerative spondylolisthesis (DS), Spinal stenosis (SpS), Low back pain (LBP), Leg pain, Surgical therapy, Randomized study, Multicenter
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute for Occupational Safety and Health (NIOSH/CDC), Office of Research on Women's Health (ORWH)
- Study start
- Mar 2000
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 4 Nov 1999 (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.
This study tests the effectiveness of different treatments for the three most commonly diagnosed conditions of the lower backbone (lumbar spine). The purpose is to learn which of two commonly prescribed treatments (surgery and nonsurgical therapy) works better for specific types of low back pain.
In this part of the study, we will treat patients with spinal stenosis (a narrowing of spaces in the backbone that results in pressure on the spinal cord and/or nerve roots) caused by degenerative spondylolisthesis (a condition in which one vertebra, or spinal bone, slips forward on another) with either surgery or nonsurgical methods. This study does not cover the cost of treatment.
Detailed description
Low back pain is considered one of the most widely experienced health problems in the U.S. and the world. It is the second most frequent condition, after the common cold, for which patients see a physician or lose days from work. Estimated costs to those who are severely disabled from low back pain range from $30-70 billion annually. Rates of spinal surgery in the U.S. have increased sharply over time, and researchers have documented 15-fold geographic variation in rates of these surgeries. In many cases, where one lives and who one sees for the condition appear to determine the rates of surgery. Despite these trends, there is little evidence proving the effectiveness of these therapies over nonsurgical management.
This study will use the National Spine Network to conduct a multicenter, randomized, controlled trial for the three most common diagnostic groups for which spine surgery is performed: lumbar intervertebral disc herniation (IDH), spinal stenosis (SpS), and spinal stenosis secondary to degenerative spondylolisthesis (DS). This arm of the trial will deal with patients from the third diagnostic group. The study will compare the most commonly used standard surgical treatments to the most commonly used standard nonsurgical treatments. We will conduct the study at 12 sites throughout the United States.
The primary endpoint of the study will be changes in health-related quality of life as measured by the SF-36 health status questionnaire. Secondary endpoints will include patient satisfaction with treatment, utility for current health in order to estimate quality-adjusted life years (QALYS) as the measure for cost-effectiveness, resource use, and cost.
We will follow patients at 6 weeks and 3, 6, 12, and 24 months to determine their health status, function, satisfaction, and health care use. We anticipate that we will enroll and randomly allocate a total of 300 study participants in this arm of the trial. We will track an additional observational cohort to assess health and resource outcomes. Enrollment in the Observational cohort has been completed as of February 2003.
We will integrate data from the trial and observational cohorts to formally estimate the cost-effectiveness of surgical versus nonsurgical interventions for IDH, SpS, and DS. The results of this trial will provide, for the first time, scientific evidence as to the relative effectiveness of surgical versus nonsurgical treatment for these three most commonly diagnosed lumbar spine conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery | Active comparator | Procedure: Decompressive laminectomy, Other: Non-surgical treatments, Procedure: Fusion--Instrumented, Procedure: Fusion-Non-instrumentedDecompressive Laminectomy Fusion-Instrumented Fusion-Non-instrumented |
| Non-surgical intervention | Active comparator | Other: Non-surgical treatmentsOther. Non-surgical treatments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Duration of Symptoms: 12 or more weeks.
- Treatments Tried: Nonsteroidal. anti-inflammatory medical therapy and physical therapy.
- Surgical Screening: Pain in low back, buttocks, or lower extremity that becomes worse with lumbar extension. Must be confirmed by evidence of central or central-lateral compression of the cauda equina by a degenerative lesion of the facet joint, disc, or ligamentum flavum on MRI, computed tomography scans, or myelograms.
- Tests: MRI to confirm diagnosis and level(s).
Key exclusion criteria (10 listed)
- Previous lumbar spine surgery.
- Not a surgical candidate for any of these reasons: Overall health that makes spinal surgery too life-threatening to be an appropriate alternative, patient has improved dramatically with conservative care, or the patient is unable (for any reason) to undergo surgery within 6 months.
- Possible pregnancy.
- Active malignancy: Patients with a history of any invasive malignancy (except nonmelanoma skin cancer) are ineligible unless they have been treated with curative intent AND have not had any clinical signs or symptoms of the malignancy for at least 5 years.
- Current fracture, infection, and/or deformity (greater than 15 degrees of lumbar scoliosis, using Cobb measure technique) of the spine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decompressive laminectomyRemoval of the hypertrophic inferior and superior articular facets will be performed when they are intruding upon the midline and causing both central and lateral recess stenosis | Procedure or surgery | Surgery |
| Non-surgical treatmentsActive physical therapy modality, Education/Counseling with home exercise instruction, and an NSAID if tolerated. Any non-operative therapies other than these are accepted and collected as data. | Other | Non-surgical intervention, Surgery |
| Fusion--InstrumentedIn addition to decompressive laminectomy, additional bilateral non-instrumented or instrumented, i.e., posterior pedicle fixation, posterolateral fusion with autogenous bone grafting (utilizing iliac crest harvested from between the tables and/or local bone) will be performed between the transverse processes and the lateral portion of the superior facets of the involved levels. | Procedure or surgery | Surgery |
| Fusion-Non-instrumentedadditional bilateral non-instrumented or instrumented, i.e., posterior pedicle fixation, posterolateral fusion with autogenous bone grafting (utilizing iliac crest harvested from between the tables and/or local bone) will be performed between the transverse processes and the lateral portion of the superior facets of the involved levels. | Procedure or surgery | Surgery |
Primary outcome
Changes in health-related quality of life as measured by the SF-36 health status questionnaire
Time frame: Baseline, 6 wks, 3 and 6 mos, Annually thereafter
4 secondary outcomes
Patient satisfaction with treatment
Time frame: Baseline, 6 wks, 3 mos, Annually thereafter
utility for current health in order to estimate quality-adjusted life years (QALYS) as the measure for cost effectiveness
Time frame: Baseline, 1 yr, 4 yr
resource utilization
Time frame: Baseline, 6 wks, 3 and 6 mos, Annually thereafter
cost
Time frame: Baseline, 6 wks, 3 and 6 mos, Annually thereafter
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 4 Aug 2015.
- Background: PubMed 12065987Birkmeyer NJ, Weinstein JN, Tosteson AN, Tosteson TD, Skinner JS, Lurie JD, Deyo R, Wennberg JE. Design of the Spine Patient outcomes Research Trial (SPORT). Spine (Phila Pa 1976). 2002 Jun 15;27(12):1361-72. doi: 10.1097/00007632-200206150-00020.
- Background: PubMed 10787504Weinstein JN, Brown PW, Hanscom B, Walsh T, Nelson EC. Designing an ambulatory clinical practice for outcomes improvement: from vision to reality--the Spine Center at Dartmouth-Hitchcock, year one. Qual Manag Health Care. 2000 Winter;8(2):1-20. doi: 10.1097/00019514-200008020-00003.
- Background: PubMed 14520044Fanciullo GJ, Hanscom B, Weinstein JN, Chawarski MC, Jamison RN, Baird JC. Cluster analysis classification of SF-36 profiles for patients with spinal pain. Spine (Phila Pa 1976). 2003 Oct 1;28(19):2276-82. doi: 10.1097/01.BRS.0000084880.33281.EB.
- Background: PubMed 12642771Lurie JD, Birkmeyer NJ, Weinstein JN. Rates of advanced spinal imaging and spine surgery. Spine (Phila Pa 1976). 2003 Mar 15;28(6):616-20. doi: 10.1097/01.BRS.0000049927.37696.DC.
- Background: PubMed 12642770Walsh TL, Hanscom B, Lurie JD, Weinstein JN. Is a condition-specific instrument for patients with low back pain/leg symptoms really necessary? The responsiveness of the Oswestry Disability Index, MODEMS, and the SF-36. Spine (Phila Pa 1976). 2003 Mar 15;28(6):607-15. doi: 10.1097/01.BRS.0000050654.97387.DF.
- Results publication: PubMed 17538085Weinstein JN, Lurie JD, Tosteson TD, Hanscom B, Tosteson AN, Blood EA, Birkmeyer NJ, Hilibrand AS, Herkowitz H, Cammisa FP, Albert TJ, Emery SE, Lenke LG, Abdu WA, Longley M, Errico TJ, Hu SS. Surgical versus nonsurgical treatment for lumbar degenerative spondylolisthesis. N Engl J Med. 2007 May 31;356(22):2257-70. doi: 10.1056/NEJMoa070302.
- Results publication: PubMed 19487505Weinstein JN, Lurie JD, Tosteson TD, Zhao W, Blood EA, Tosteson AN, Birkmeyer N, Herkowitz H, Longley M, Lenke L, Emery S, Hu SS. Surgical compared with nonoperative treatment for lumbar degenerative spondylolisthesis. four-year results in the Spine Patient Outcomes Research Trial (SPORT) randomized and observational cohorts. J Bone Joint Surg Am. 2009 Jun;91(6):1295-304. doi: 10.2106/JBJS.H.00913.
- Results publication: PubMed 22048651Tosteson AN, Tosteson TD, Lurie JD, Abdu W, Herkowitz H, Andersson G, Albert T, Bridwell K, Zhao W, Grove MR, Weinstein MC, Weinstein JN. Comparative effectiveness evidence from the spine patient outcomes research trial: surgical versus nonoperative care for spinal stenosis, degenerative spondylolisthesis, and intervertebral disc herniation. Spine (Phila Pa 1976). 2011 Nov 15;36(24):2061-8. doi: 10.1097/BRS.0b013e318235457b.
- Derived from this study: PubMed 19755935Abdu WA, Lurie JD, Spratt KF, Tosteson AN, Zhao W, Tosteson TD, Herkowitz H, Longely M, Boden SD, Emery S, Weinstein JN. Degenerative spondylolisthesis: does fusion method influence outcome? Four-year results of the spine patient outcomes research trial. Spine (Phila Pa 1976). 2009 Oct 1;34(21):2351-60. doi: 10.1097/BRS.0b013e3181b8a829.
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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.
James N. Weinstein, DO, MS principal investigator
Dartmouth-Hitchcock Medical Center
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Decompressive laminectomy, Non-surgical treatments and Fusion--Instrumented in people with Spondylolisthesis and Spinal Stenosis, run by Dartmouth-Hitchcock Medical Center at 13 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 10 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 4 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes in health-related quality of life as measured by the SF-36 health status questionnaire (time frame: Baseline, 6 wks, 3 and 6 mos, Annually thereafter). 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 NCT00000409, which also lists 9 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 4 Aug 2015.