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Prospective Study of Minimally Invasive Spine Surgery

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ClinicalTrials.gov Identifier: NCT01045473
Recruitment Status : Unknown
Verified January 2010 by Society for Minimally Invasive Spine Surgery.
Recruitment status was:  Not yet recruiting
First Posted : January 11, 2010
Last Update Posted : January 11, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
The population of the US is aging. They remain more active and place greater demands on their musculoskeletal system. A key problem is that pain and disability of age related spinal disorders will increase. Problems such as Degenerative Lumbar Spondylolisthesis, Degenerative Disk Disease, Spinal Stenosis and Degenerative Scoliosis are age related problems that are treated with spinal fusion when non-operative treatment fails. Traditional open surgery poses significant risk for patients in this age group. The use of minimally invasive spinal surgery techniques provides an opportunity to treat these patients with less morbidity than traditional open surgery.

Condition or disease
Degenerative Disk Disease Spondylolisthesis Spinal Stenosis Degenerative Scoliosis

Study Design

Study Type : Observational
Estimated Enrollment : 450 participants
Time Perspective: Prospective
Official Title: Prospective Study of Minimally Invasive Spinal Fusion Surgery for the Treatment of Spondylolisthesis, Degenerative Disk Disease, Spinal Stenosis and Degenerative Scoliosis
Study Start Date : January 2010
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Orthropedic surgeon's clinic. Neurosurgeon's clinic.
Criteria

Inclusion Criteria: Inclusion Criteria:

  • Patient age 21 - 90 years.
  • Diagnosis of Spondylolisthesis, degenerative disk disease, and degenerative scoliosis (any curve magnitude).
  • A spinal fusion is being undertaken via the minimally invasive approach.
  • The patient agrees to follow-up for routine care for at least 2 years post-operatively.

Exclusion Criteria:

  • Inability for post-operative follow-up
More Information

Additional Information:
Responsible Party: Greg Anderson, MD, Society for Minimally Invasive Spine Surgery
ClinicalTrials.gov Identifier: NCT01045473     History of Changes
Other Study ID Numbers: SMISS-001
First Posted: January 11, 2010    Key Record Dates
Last Update Posted: January 11, 2010
Last Verified: January 2010

Keywords provided by Society for Minimally Invasive Spine Surgery:
MIS
Minimally Invasive Spine Surgery
Fusion
Spine
SMISS

Additional relevant MeSH terms:
Constriction, Pathologic
Scoliosis
Spinal Stenosis
Intervertebral Disc Degeneration
Spondylolisthesis
Pathological Conditions, Anatomical
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis