Intervertebral Disc Nucleus Augmentation With Allograft Meniscus With Minimally Invasive Surgical Procedure
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Degenerative Disc Disease
- Sponsor
- University of Florida
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Visual Analog Scale (VAS) documentation of the level of back pain. The (VAS) will describe the change in the level of back pain from the pre-op level.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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 of a degenerative intervertebral disc.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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.)
Outcomes
Primary Outcomes
Visual Analog Scale (VAS) documentation of the level of back pain. The (VAS) will describe the change in the level of back pain from the pre-op level.
Time Frame: Patients will complete the (VAS) at pre-op and at 6 wks. and at 3, 6, 12, and 24 mos. post-operatively.
Patients will complete the (VAS) pre-operatively and post-operatively at 6 wks, and 3, 6, 12, and 24 mos. Responses are expressed on a ten centimeter line, with 0 representing no pain and 10cm representing the worst pain possible. The patient places a mark across the line representing where their perceived pain lies, from no pain to severe pain.
Secondary Outcomes
- The Oswestry Low Back Pain Disability Questionnaire (OLBPQ) function assessment The (OLBPQ) will describe the change in the level of function from the pre-op level.(Patients will complete the (OLBPQ) at pre-op and at 6 wks. and at 3, 6, 12, and 24 mos. post-operatively.)