Spinal DiseasesNCT00635934
A-MAV™ Anterior Motion Segment Replacement
A study testing A-MAV™ disc in people with Spinal Diseases, run by Medtronic Spinal and Biologics at 3 sites in United States.
Trial summary
The purpose of this clinical trial is to collect safety and effectiveness data concerning the A-MAV™ Anterior Motion Segment Replacement device as a method of treating patients with lumbar degenerative disc disease at one level from L4-S1. Overall success will be the primary clinical endpoint. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Diseases
- What is being tested?
- A-MAV™ disc
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2005to May 2010
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has back and/or radicular pain with degeneration of the disc as confirmed by patient history, physical examination, and radiographic studies with one or more of the following factors:
- instability as defined by > 5° angulation
- osteophyte formation of facet joints or vertebral endplates
- decreased disc height, on average by >2mm, relative to the next adjacent vertebral segment
- scarring/thickening of ligamentum flavum, annulus fibrosis, or facet joint capsule
- herniated nucleus pulposus
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- facet joint degeneration/changes
- vacuum phenomenon
- Has single-level symptomatic degenerative involvement from L4-S1 requiring surgical treatment
- Has intact facet joints at the involved vertebral levels documented by CT and/or MRI
- Has preop Oswestry score≥30
- Has preop back pain score ≥8
- Age 18 to 70 yrs, inclusive and is skeletally mature
- Has not responded to non-operative treatment for 6 mos
- If child-bearing potential, patient is non-pregnant, non-nursing, and agrees not to become pregnant for 1 yr after surgery
- Is willing and able to comply with the study plan and sign the Patient Informed Consent Form
Who cannot join
- Has primary diagnosis of a spinal disorder other than DDD at involved level
- Had previous anterior lumbar spinal surgery at involved level
- Had previous posterior lumbar spinal fusion surgical procedure at involved level
- Had prior posterior lumbar surgery resulting in significant muscle/ligament morbidity, not including facet saving techniques
- Requires surgical intervention at more than 1 lumbar level
- Has severe pathology of facet joints of involved vertebral bodies
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- Has facet arthritis or any posterior element insufficiency
- Has spondylolisthesis
- Has mid-sagittal stenosis of <8mm, based on remaining canal diameter
- Has rotatory scoliosis at involved level
- Has lumbar scoliosis with >11° sagittal plane deformity
- Had previous trauma to L4, L5, or S1 levels in compression or burst
- Meets any of the following criteria: Previous diagnosis of osteoporosis, osteopenia, or osteomalacia; postmenopausal Non-Black female over 60 yrs of age and weighs less than 140 pounds; postmenopausal female that has sustained a non-traumatic hip, spine or wrist fracture; male over age 60 that has sustained a non-traumatic hip or spine fracture. If Yes to any of these, a DEXA scan is required. If level of BMD is -3.5 or lower or -2.5 or lower with vertebral crush fracture, the patient is excluded
- Had previous lumbar spinal fusion at adjacent level
- Bone growth stimulator use in spine
- Has obesity defined by BMI greater than or equal to 40
- Has arachnoiditis
- Has a non-contained or extruded herniated nucleus pulposus with acute nerve root compression
- Has condition that requires postop medications that interfere with bone metabolism, such as chronic steroid use or prolonged use of non-steroidal anti-inflammatory drugs, excluding routine perioperative, non-steroidal anti-inflammatory drugs. Does not include low dose aspirin for prophylactic anticoagulation
- Has overt or active bacterial infection, either local or systemic and/or potential for bacteremia
- Has presence or prior history of malignancy (except for basal cell carcinoma of skin)
- Has documented metal allergy, titanium alloy intolerance or cobalt-chrome-molybdenum alloy
- Is mentally incompetent. If questionable, obtain psych consult
- Has a Waddell Signs of Inorganic Behavior score of 3 or greater
- Has chronic or acute renal and/or hepatic failure or prior history of renal and/or hepatic parenchymal disease
- Is prisoner
- Is pregnant
- Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse
- Has history of autoimmune disease
- Has received treatment with an investigational therapy within 30 days prior to implantation surgery or treatment is planned during 24 months following the implantation surgery
- Has history of any endocrine or metabolic disorder known to affect osteogenesis
- Has any disease that would preclude accurate clinical evaluation
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Central Texas Spine
Austin, Texas, 78731
Orthopedic Center of St. Louis
Chesterfield, Missouri, 63017
Hughston Clinic
Columbus, Georgia, 31908
About this study
Official title: A Prospective, Non-Randomized Pilot Clinical Investigation of the A-MAV™ Anterior Motion Segment Replacement in Patients With Lumbar Degenerative Disc Disease
The purpose of this clinical trial is to collect safety and effectiveness data concerning the A-MAV™ Anterior Motion Segment Replacement device as a method of treating patients with lumbar degenerative disc disease at one level from L4-S1. Overall success will be the primary clinical endpoint.
Read the detailed description
For this clinical trial, there is only one treatment group- patients receiving the A-MAV™ Anterior Motion Segment Replacement via an anterior surgical approach in the lumbar region of the spine from L4-S1.
- Conditions
- Spinal Diseases
- Being tested
- A-MAV™ disc
- Keywords
- Lumbar Degenerative Disc Disease at One Level from L4-S1
- Medical subject headings
- Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A-MAV™ discDevice
Also called A-MAV™
The A-MAV™ device is a spinal arthroplasy system intended to replace a damaged spinal disc. It is inserted using an anterior surgical approach and aims to reduce low back pain and maintain disc height at the affected level.
| Study group | Role | What they receive |
|---|---|---|
| A-MAV™disc | Experimental | Not described Receives: Device: A-MAV™ disc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Success= Oswestry Disability Index success; Maintenance or improvement in neurological status; No serious AE classified as implant or implant/surgical procedure associated; No additional surgical procedure classified as a failure
Measured: 24 Months
Secondary outcomes (1)
Disc height; SF-36; Back Pain Status; Leg Pain Status; Patient Satisfaction; Patient Global Perceived Effect; Other Measurements-Radiographic; Return to Work; Doctor's Perception of Results
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startDec 2005
- Primary completionOct 2009
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal DiseasesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Spinal and Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635934
- Sponsor's protocol ID
- P04-05
- Status last verified
- Oct 2011
- First submitted
- 7 Mar 2008
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-Randomized Pilot Clinical Investigation of the A-MAV™ Anterior Motion Segment Replacement in Patients With Lumbar Degenerative Disc Disease
- ClinicalTrials.gov ID
- NCT00635934
- Acronym / sponsor ID
- P04-05
- Conditions
- Spinal Diseases
- Keywords
- Lumbar Degenerative Disc Disease at One Level from L4-S1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Medtronic Spinal and BiologicsIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Oct 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 14 Mar 2008 (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 purpose of this clinical trial is to collect safety and effectiveness data concerning the A-MAV™ Anterior Motion Segment Replacement device as a method of treating patients with lumbar degenerative disc disease at one level from L4-S1. Overall success will be the primary clinical endpoint.
Detailed description
For this clinical trial, there is only one treatment group- patients receiving the A-MAV™ Anterior Motion Segment Replacement via an anterior surgical approach in the lumbar region of the spine from L4-S1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A-MAV™disc | Experimental | Device: A-MAV™ disc |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Has back and/or radicular pain with degeneration of the disc as confirmed by patient history, physical examination, and radiographic studies with one or more of the following factors:
- Has single-level symptomatic degenerative involvement from L4-S1 requiring surgical treatment
- Has intact facet joints at the involved vertebral levels documented by CT and/or MRI
- Has preop Oswestry score≥30
- Has preop back pain score ≥8
Key exclusion criteria (32 listed)
- Has primary diagnosis of a spinal disorder other than DDD at involved level
- Had previous anterior lumbar spinal surgery at involved level
- Had previous posterior lumbar spinal fusion surgical procedure at involved level
- Had prior posterior lumbar surgery resulting in significant muscle/ligament morbidity, not including facet saving techniques
- Requires surgical intervention at more than 1 lumbar level
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 |
|---|---|---|
| A-MAV™ discAlso: A-MAV™The A-MAV™ device is a spinal arthroplasy system intended to replace a damaged spinal disc. It is inserted using an anterior surgical approach and aims to reduce low back pain and maintain disc height at the affected level. | Device | A-MAV™disc |
Primary outcome
Overall Success= Oswestry Disability Index success; Maintenance or improvement in neurological status; No serious AE classified as implant or implant/surgical procedure associated; No additional surgical procedure classified as a failure
Time frame: 24 Months
1 secondary outcome
Disc height; SF-36; Back Pain Status; Leg Pain Status; Patient Satisfaction; Patient Global Perceived Effect; Other Measurements-Radiographic; Return to Work; Doctor's Perception of Results
Time frame: 24 Months
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 18 Sep 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A-MAV™ disc in people with Spinal Diseases, run by Medtronic Spinal and Biologics at 3 sites 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 16 inclusion and 32 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 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Overall Success= Oswestry Disability Index success; Maintenance or improvement in neurological status; No serious AE classified as implant or implant/surgical procedure associated; No additional surgical procedure classified as a failure (time frame: 24 Months). 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 18 Sep 2018.