Intervertebral Disc Augmentation With Minimally Invasive Surgical Procedure

University of Florida

Status: Completed

Conditions: Degenerative Disc Disease

Treatments: Other: completion of the (VAS) for level of back pain; Other: completion of the (OLBPQ) for assessment of function

Study type: Observational

Funder types: Other

Identifiers

NCT01442922

37-2011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 44 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

1 participants in 1 patient group

Human Meniscus Allograft (HMA)

Description:

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.

Treatment:

Other: completion of the (VAS) for level of back pain

Other: completion of the (OLBPQ) for assessment of function