Status:
COMPLETED
Intervertebral Disc Augmentation With Minimally Invasive Surgical Procedure
Lead Sponsor:
University of Florida
Conditions:
Degenerative Disc Disease
Eligibility:
All Genders
18-44 years
Brief Summary
The primary purpose of the study is to establish the degree and duration of pain relief following minimally invasive surgery for a painful degenerative disc.
Detailed Description
The investigators will study patient recovery (outcome measures) in patients who have had minimally invasive surgery for implantation of human meniscus allograft (HMA) to replace the nucleus pulposus ...
Eligibility Criteria
Inclusion
- diagnosis of degenerative disk disease at L3-L4, L4-L5, or L5-S1
- low back for no more that one year prior to enrollment
Exclusion
- Osteoporosis
- Degenerative changes of vertebral endplates (obvious fractures, osteophytes)
- Modic Type II changes indicative of advanced bony degeneration
- Facet arthrosis (loss of facet joint cartilage, increased synovial fluid collection, or presence of osteophytes in inferior or superior plates)
- Discs classified with stage I or II degeneration
- Patients unable to have an MRI (pacemaker, claustrophobia, etc.)
Key Trial Info
Start Date :
March 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01442922
Start Date
March 1 2011
End Date
December 1 2012
Last Update
January 17 2013
Active Locations (1)
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1
UF&Shands Orthopaedics and Sports Medicine Institute
Gainesville, Florida, United States, 32607