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OpenTrials
Completed

NCT Number: NCT01220921

Neurosurgery Patient Outcomes in Treating Spinal Disorders

The creation of a multi-center cooperative research group encompassing academic and community-based spinal practices . . .

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Key information

Conditions

Symptomatic Lumbar Disc Herniation Symptomatic Grade I Lumbar Spondylolisthesis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Calgary - Alberta Health Sevices, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Grade I degenerative or isthmic spondylolisthesis recalcitrant to non-invasive therapies for at least 3 months or Lumbar degenerative disc herniation with radiculopathy refractory to non-invasive therapies for at least 6 weeks

Exclusion criteria

  • History of previous lumbar spine surgery
  • Significant motor weakness (3/5) (i.e. foot drop)
  • Cancer, infection, or fracture
  • Pregnancy

Treatment and study plan

lumbar discectomy

Procedure

Microsurgical removal of disc that is compressing a nerve root

Single-level lumbar fusion

Procedure

pedicle screws with arthrodesis as directed by surgeon. Fusion can be posterolateral, interbody, or both.

Primary outcomes

  1. SF-36 version 1

    Time frame: 1-Year

    Health-realted quality of life outcome measure

  2. Site and Physician Compliance

    Time frame: 1 Year

    Goal = 80% compliance in enrolling 20 patients over 1 year with completed outcomes instruments

Secondary outcomes

  1. Oswestry Disability Index (ODI)

    Time frame: 1 Year

    Validated lumbar spine disease-specific outcomes instrument

  2. Visual Analog Pain Score

    Time frame: 1 Year

    Patient-reported pain intensity scored 1-10

  3. Return to Work

    Time frame: 1 Year

    Return to work assessments will be performed at 1,3,6, and 12 months post-operatively

  4. 30 day complications

    Time frame: 30 days

    death, myocardial infarction (MI), pulmonary embolism (PE), readmission, wound infection, new neurological deficit, re-operation

  5. Delayed Surgical Complications

    Time frame: 1 year

    re-operation, fusion complication, problems with hardware, deformity

Sponsors and collaborators

Lead sponsor

Greenwich Hospital

Other

Collaborators

  • American Association of Neurological Surgeons

Registry information

Acronym: Neuropoint SD

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Oct 14, 2010
Registry last updated
Dec 4, 2015

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.