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NCT01045473 Clinical Trial

Prospective Study of Minimally Invasive Spine Surgery

Spinal Stenosis Clinical Trial

Official title:
Prospective Study of Minimally Invasive Spinal Fusion Surgery for the Treatment of Spondylolisthesis, Degenerative Disk Disease, Spinal Stenosis and Degenerative Scoliosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01045473
Other study ID # SMISS-001
Secondary ID
Status Not yet recruiting
Phase N/A
First received January 7, 2010
Last updated January 8, 2010
Start date January 2010
Est. completion date June 2012

Study information
Verified date January 2010
Source Society for Minimally Invasive Spine Surgery
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 450
Est. completion date June 2012
Est. primary completion date January 2012
Accepts healthy volunteers No
Gender Both
Age group 21 Years to 90 Years
Eligibility 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Society for Minimally Invasive Spine Surgery
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