Intervertebral Disc Augmentation With Minimally Invasive Surgical Procedure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-12-31

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.

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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.

Conditions

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Degenerative Disc Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Human Meniscus Allograft (HMA)

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.

completion of the (VAS) for level of back pain

Intervention Type OTHER

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 function

Intervention Type OTHER

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

Interventions

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completion 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.

Intervention Type OTHER

completion 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.

Intervention Type OTHER

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.)

Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No