Intervertebral Disc Augmentation With Minimally Invasive Surgical Procedure

Degenerative Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01442922
• Other study ID #: 37-2011
• Status: Completed
• Phase: N/A
• First received: September 23, 2011
• Last updated: January 16, 2013
• Start date: March 2011
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 44 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
United States	UF&Shands Orthopaedics and Sports Medicine Institute	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No