Degenerative Disc DiseaseNCT01442922
Intervertebral Disc Augmentation With Minimally Invasive Surgical Procedure
An observational study of Degenerative Disc Disease, run by University of Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 44 years
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- completion of the (VAS) for level of back pain and completion of the (OLBPQ) for assessment of function
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- diagnosis of degenerative disk disease at L3-L4, L4-L5, or L5-S1
- low back for no more that one year prior to enrollment
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
United States1 site
UF&Shands Orthopaedics and Sports Medicine Institute
Gainesville, Florida, 32607
About this study
Official title: 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.
Read the 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.
- Conditions
- Degenerative Disc Disease
- Being tested
- completion of the (VAS) for level of back pain, completion of the (OLBPQ) for assessment of function
- Keywords
- L3-L4, L4-L5, L5-S1, Human Meniscus Allograft, Nucleus pulposus, Minimally invasive surgery, Degeneration of L3-L4 Intervertebral Disc, Degeneration of L4-L5 Intervertebral Disc, Degeneration of L5-S1 Intervertebral Disc
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: completion of the (VAS) for level of back pain; Other: completion of the (OLBPQ) for assessment of function |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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) 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.
Measured: Patients will complete the (OLBPQ) at pre-op and at 6 wks. and at 3, 6, 12, and 24 mos. post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Mac Millan, M.D., Principal investigator, University of Florida Department of Orthopaedics and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01442922
- Sponsor's protocol ID
- 37-2011
- Status last verified
- Dec 2012
- First submitted
- 23 Sep 2011
- Last updated
- 17 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervertebral Disc Nucleus Augmentation With Allograft Meniscus With Minimally Invasive Surgical Procedure
- ClinicalTrials.gov ID
- NCT01442922
- Acronym / sponsor ID
- 37-2011
- Conditions
- Degenerative Disc Disease
- Keywords
- L3-L4, L4-L5, L5-S1, Human Meniscus Allograft, Nucleus pulposus, Minimally invasive surgery, Degeneration of L3-L4 Intervertebral Disc, Degeneration of L4-L5 Intervertebral Disc
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 29 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Human Meniscus Allograft (HMA) | – | Other: completion of the (VAS) for level of back pain, Other: completion of the (OLBPQ) for assessment of functionPatients with degenerative disk disease at L3-L4, L4-L5, or L5-S1 scheduled to undergo surgery for (HMA) implantation to replace the nucleus pulposus. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- diagnosis of degenerative disk disease at L3-L4, L4-L5, or L5-S1
- low back for no more that one year prior to enrollment
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| completion of the (VAS) for level of back painPatients will complete the (VAS) pre-operatively and post-operatively at 6 wks, and 3, 6, 12, and 24 mos. | Other | Human Meniscus Allograft (HMA) |
| completion of the (OLBPQ) for assessment of functionPatients will complete the (OLBPQ) pre-operatively and post-operatively at 6 wks, and 3, 6, 12, and 24 mos. | Other | Human Meniscus Allograft (HMA) |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Mac Millan, M.D. principal investigator
University of Florida Department of Orthopaedics and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2013.