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Prospective Study of Minimally Invasive Spine Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Society for Minimally Invasive Spine Surgery.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Society for Minimally Invasive Spine Surgery
ClinicalTrials.gov Identifier:
NCT01045473
First received: January 7, 2010
Last updated: January 8, 2010
Last verified: January 2010
History of Changes
  Purpose

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
Degenerative Disk Disease
Spondylolisthesis
Spinal Stenosis
Degenerative Scoliosis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Society for Minimally Invasive Spine Surgery:

Estimated Enrollment: 450
Study Start Date: January 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   21 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Greg Anderson, MD, Society for Minimally Invasive Spine Surgery
ClinicalTrials.gov Identifier: NCT01045473     History of Changes
Other Study ID Numbers: SMISS-001
Study First Received: January 7, 2010
Last Updated: January 8, 2010
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 16, 2013