Intervertebral Disc Augmentation With Minimally Invasive Surgical Procedure

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intervertebral Disc Nucleus Augmentation With Allograft Meniscus With Minimally Invasive Surgical Procedure

Conditions
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Degenerative Disc Disease

Intervention / Treatment
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* Other: completion of the (VAS) for level of back pain
* Other: completion of the (OLBPQ) for assessment of function


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Human Meniscus Allograft (HMA)<br>Patients with degenerative disk disease at L3-L4, L4-L5, or L5-S1 scheduled to undergo surgery for (HMA) implantation to replace the nucleus pulposus. | Other: completion of the (VAS) for level of back pain<br>* Patients will complete the (VAS) pre-operatively and post-operatively at 6 wks, and 3, 6, 12, and 24 mos.<br>Other: completion of the (OLBPQ) for assessment of function<br>* Patients will complete the (OLBPQ) pre-operatively and post-operatively at 6 wks, and 3, 6, 12, and 24 mos.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) 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. | Patients will complete the (VAS) at pre-op and at 6 wks. and at 3, 6, 12, and 24 mos. post-operatively. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) 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. | Patients will complete the (OLBPQ) at pre-op and at 6 wks. and at 3, 6, 12, and 24 mos. post-operatively. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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