Intervertebral Disc Augmentation With Minimally Invasive Surgical Procedure

Completed

• Conditions: Degenerative Disc Disease
• Interventions: Other: completion of the (VAS) for level of back pain; Other: completion of the (OLBPQ) for assessment of function

• Registration Number: NCT01442922
• Lead Sponsor: University of Florida

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.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-09-23
• Study First Submitted QC: 2011-09-28
• Study First Posted: 2011-09-29
• Status Verified: 2012-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2013-01-16
• Last Update Posted: 2013-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Human Meniscus Allograft (HMA)	completion of the (VAS) for level of back pain	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.
Human Meniscus Allograft (HMA)	completion of the (OLBPQ) for assessment of function	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

UF&Shands Orthopaedics and Sports Medicine Institute; 🇺🇸 Gainesville, Florida, United States