Intervertebral Disc Augmentation With Minimally Invasive Surgical Procedure

University of Florida1 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Degenerative Disc Disease

Interventions

completion of the (VAS) for level of back painOTHER

Patients will complete the (VAS) pre-operatively and post-operatively at 6 wks, and 3, 6, 12, and 24 mos.

completion of the (OLBPQ) for assessment of functionOTHER

Patients will complete the (OLBPQ) pre-operatively and post-operatively at 6 wks, and 3, 6, 12, and 24 mos.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 44 Years

Medical Language ↔ Plain English

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.)

Locations (1)

UF&Shands Orthopaedics and Sports Medicine Institute

Gainesville, Florida, United States

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.

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.

Time frame: Patients will complete the (VAS) at pre-op and at 6 wks. and at 3, 6, 12, and 24 mos. post-operatively.

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) 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.

Time frame: Patients will complete the (OLBPQ) at pre-op and at 6 wks. and at 3, 6, 12, and 24 mos. post-operatively.

Data from ClinicalTrials.gov

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