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Completed

NCT Number: NCT01442922

Intervertebral Disc Augmentation 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.

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Key information

Conditions

Degenerative Disc Disease Bone Diseases Intervertebral Disc Degeneration Musculoskeletal Diseases Spinal Diseases

Age range

18 year–44 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UF&Shands Orthopaedics and Sports Medicine Institute

Gainesville, Florida, 32607, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

completion of the (VAS) for level of back pain

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

Other

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

Primary outcomes

  1. 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.

    Time frame: 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 outcomes

  1. 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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 29, 2011
Registry last updated
Jan 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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