Spine Patient Outcomes Research Trial (SPORT) - Intervertebral Disc Herniation

Low back pain is considered one of the most widely experienced health problems in the United
States and the world. This condition is the second most frequent condition, after the common
cold, for which people 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 problem appear to determine the rates of surgery. Despite these trends,
there is little evidence proving the effectiveness of these therapies over non-surgical
management.

Overall, the SPORT study is 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 first
diagnostic group. The study will compare the most commonly used standard surgical treatments
to the most commonly used standard non-surgical 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 use of health care. In this arm of the trial, we
anticipate enrolling and randomly allocating a total of 500 participants. We will track an
additional observational cohort to assess health and resource outcomes (1000 participants).
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 non-surgical interventions for IDH, SpS, and DS. On
the basis of the results of this trial we will, for the first time, have scientific evidence
as to the relative effectiveness of surgical versus non-surgical treatment for these three
most commonly diagnosed lumbar spine conditions.

Inclusion Criteria:

- Duration of symptoms: 6 or more weeks.

- Treatments tried: Non-steroidal anti-inflammatory medical therapy and physical
therapy.

- Surgical screening: Persistent radicular pain provoked by moderate exercise, sitting,
increased abdominal pressure, decreased mobility, list (scoliosis), straight leg
raising.

- 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 which makes spinal
surgery too life-threatening to be an appropriate alternative, dramatic improvement
with conservative care, or inability (for any reason) to undergo surgery within 6
months.

- Possible pregnancy.

- Active malignancy: A patient with a history of any invasive malignancy (except
non-melanoma skin cancer) is ineligible unless he or she has been treated with a
curative intent AND there has been no 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 neurological deficit (usually requiring urgent
surgery).

- Unavailability for follow-up (planning to move, no telephone, etc.) or inability to
complete data surveys.

- Symptoms less than 6 weeks.

- Patient currently enrolled in any experimental "spine related" study.