NCT01442922

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 29, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 17, 2013

Status Verified

December 1, 2012

Enrollment Period

1.8 years

First QC Date

September 23, 2011

Last Update Submit

January 16, 2013

Conditions

Degenerative Disc Disease

Keywords

L3-L4L4-L5L5-S1Human Meniscus AllograftNucleus pulposusMinimally invasive surgeryDegeneration of L3-L4 Intervertebral DiscDegeneration of L4-L5 Intervertebral DiscDegeneration of L5-S1 Intervertebral Disc

Outcome Measures

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.

    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 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.

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

Study Arms (1)

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

Interventions

completion of the (VAS) for level of back painOTHER

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

Human Meniscus Allograft (HMA)
completion of the (OLBPQ) for assessment of functionOTHER

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

Human Meniscus Allograft (HMA)

Eligibility Criteria

Age18 Years - 44 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • diagnosis of degenerative disk disease at L3-L4, L4-L5, or L5-S1
  • low back for no more that one year prior to enrollment

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UF&Shands Orthopaedics and Sports Medicine Institute

Gainesville, Florida, 32607, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Michael Mac Millan, M.D.

    University of Florida Department of Orthopaedics and Rehabilitation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2011

First Posted

September 29, 2011

Study Start

March 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 17, 2013

Record last verified: 2012-12

Locations

US(1)