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:

MedlinePlus related topics: Scoliosis Spinal Stenosis

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site


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 Stenosis Constriction, Pathologic Scoliosis Intervertebral Disc Degeneration Spondylolisthesis Pathological Conditions, Anatomical	Spinal Curvatures Spinal Diseases Bone Diseases Musculoskeletal Diseases Spondylolysis Spondylosis

ClinicalTrials.gov processed this record on September 23, 2016

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