Degenerative Disc Disease
Conditions
Keywords
L3-L4, L4-L5, L5-S1, Human Meniscus Allograft, Nucleus pulposus, Minimally invasive surgery, Degeneration of L3-L4 Intervertebral Disc, Degeneration of L4-L5 Intervertebral Disc, Degeneration of L5-S1 Intervertebral Disc
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.
Interventions
OTHERcompletion of the (VAS) for level of back pain
Patients will complete the (VAS) pre-operatively and post-operatively at 6 wks, and 3, 6, 12, and 24 mos.
OTHERcompletion of the (OLBPQ) for assessment of function
Patients will complete the (OLBPQ) pre-operatively and post-operatively at 6 wks, and 3, 6, 12, and 24 mos.
Sponsors
University of Florida
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 44 Years
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | Patients will complete the (OLBPQ) pre-operatively and post-operatively at 6 wks, and 3, 6, 12, and 24 mos. This is a 10-question self-rating scale used to evaluate the degree of functional impairment a patient is experiencing in a number of activities of daily living. |
Countries
United States
Outcome results
None listed