Spine Patient Outcomes Research Trial (SPORT): Degenerative Spondylolisthesis With Spinal Stenosis

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.

Inclusion Criteria:

- 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).

Exclusion Criteria:

- 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.

- 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.