Intervertebral Disc Augmentation With Minimally Invasive Surgical Procedure

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

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.

Study Overview

• Status: Completed
• Conditions: Degenerative Disc Disease
• Intervention / Treatment: Other: completion of the (VAS) for level of back pain; Other: completion of the (OLBPQ) for assessment of function

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 Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32607
      • UF&Shands Orthopaedics and Sports Medicine Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Michael Mac Millan, M.D., University of Florida Department of Orthopaedics and Rehabilitation

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: September 23, 2011
• First Submitted That Met QC Criteria: September 28, 2011
• First Posted (Estimate): September 29, 2011

Study Record Updates

• Last Update Posted (Estimate): January 17, 2013
• Last Update Submitted That Met QC Criteria: January 16, 2013
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Minimally invasive surgery; Nucleus pulposus; L3-L4; L4-L5; L5-S1; Human Meniscus Allograft; Degeneration of L3-L4 Intervertebral Disc; Degeneration of L4-L5 Intervertebral Disc; Degeneration of L5-S1 Intervertebral Disc
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: 37-2011