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Lumbar Spine DegenerationPhase 3TLIFNCT01415908

INFUSE®Bone Graft in Transforaminal Lumbar Interbody Fusion for Degenerative Disease of Lumbosacral Spine

A Phase 3 study testing INFUSE Bone Graft and Iliac Crest Bone Graft in people with Lumbar Spine Degeneration, run by Medtronic Spinal and Biologics at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This investigation will provide safety and effectiveness information on the use of INFUSE® Bone Graft with the CAPSTONE® Spinal System and CD HORIZON® Spinal System with a Transforaminal Lumbar Interbody Fusion (TLIF) surgical approach at one or two adjacent levels from L2-S1 to treat subjects with advanced… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lumbar Spine Degeneration
What is being tested?
INFUSE Bone Graft and Iliac Crest Bone Graft
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
5 sitesUnited States
Study dates
Jul 2011to Jan 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has advanced degenerative disease of the lumbosacral spine (L2 to S1) that results in radiculopathy secondary to nerve root compression, manifested by, History of radiating leg or buttock pain, paresthesias, numbness or weakness, or History of neurogenic claudication.
  • Has a history of low back pain
  • Has radiographic evidence of advanced degenerative lumbosacral disease, such as decreased disc height; herniated nucleus pulposus; hypertrophy or thickening of the ligamentum flavum, annulus fibrosis, or facet joint capsule; hypertrophied facet joints, facet joint space narrowing, or facet periarticular osteophyte formation; trefoil canal shape; or lateral(subarticular) stenosis; or vertebral endplate osteophyte formation; and at least one of the following:
  • Sagittal plane translation (slippage) of the superior (cranial) vertebral body anterior or posterior to the inferior (caudal) vertebral body greater than 3mm, or Coronal plane translation (slippage) of the superior (cranial) vertebral body lateral to the inferior (caudal) vertebral body greater than 3mm, or Narrowing (stenosis) of the lumbar spinal canal and/or intervertebral foramen
  • Has single-level or adjacent two-level involvement from L2 to S1.
  • Has preoperative Oswestry score ≥30.
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  • Has preoperative back pain score of ≥ 6 based on the Preoperative Back and Leg Pain Questionnaire (pain intensity + pain frequency).
  • Has preoperative leg pain score of ≥ 6 based on the Preoperative Back and Leg Pain Questionnaire (pain intensity + pain frequency).
  • Is at least 18 years of age and skeletally mature at the time of surgery.
  • Has not responded to non-operative treatment (e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS) for a period of six months.
  • Is willing and able to comply with the study plan and able to understand and sign the Subject Informed Consent Form.

Who cannot join

  • Requires spinal fusion at more than two lumbar levels or at two non-adjacent levels.
  • Has had a prior lumbar surgical fusion procedure at the involved or adjacent spinal levels.
  • Has significant lumbar instability, defined as sagittal or coronal plane listhesis greater than Grade 2 spondylolisthesis utilizing Meyerding's Classification (Meyerding, HW, 1932).
  • Has scoliosis greater than 30 degrees.
  • Has had a previous diagnosis of osteoporosis, osteopenia, or osteomalacia.
  • In addition, if the subject has any of the following risk factors, a DEXA scan should be performed to determine eligibility:
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  • History of a non-traumatic hip or spine fracture. Female who is postmenopausal. Female over the age of 65. Male over the age of 70. If the DEXA T-score is -2.5 or lower, OR a T-score of -1.5 or lower WITH a history of a vertebral compression fracture, the subject is excluded.
  • Is morbidly obese, as defined as a Body Mass Index (BMI) > 40.
  • Has an active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).
  • Has an overt or active bacterial infection, either local or systemic.
  • Has undergone systemic administration of any type of corticosteroid, anti-neoplastic, immunostimulating, or immunosuppressive agents within 30 days prior to implantation of the assigned treatment.
  • Has a history of clinically significant cardiac or hematologic disease.
  • Has a history of autoimmune disease known to affect bone metabolism or the spine. Examples include spondyloarthropathies (e.g., ankylosing spondylitis, Crohn's disease, and ulcerative colitis), juvenile arthritis, rheumatoid arthritis, Grave's disease, and Hashimoto's thyroiditis.
  • Has a medical disease or condition that would preclude accurate clinical evaluation of the safety and effectiveness of the treatments in this study, such as motor weakness, sensory loss, or painful conditions that inhibit normal ambulation or other activities of daily living.
  • Has a history of any endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehlers-Danlos syndrome, or osteogenesis imperfecta).
  • Has chronic or acute renal and/or hepatic failure or prior history of renal and/or hepatic parenchymal disease.
  • Has a history of exposure to injectable collagen.
  • Has received any previous exposure to any/all BMPs of either human or animal extraction.
  • Has a history of hypersensitivity to collagen or protein pharmaceuticals (e.g., monoclonal antibodies or gamma globulins).
  • Has a history of any allergy resulting in anaphylaxis.
  • Has a history of allergy to bovine products.
  • Has a documented allergy or intolerance to titanium, titanium alloy, tantalum, tantalum alloy, or polyetheretherketone (PEEK).
  • Has any condition in which MRI scans are contraindicated (e.g., cardiac pacemaker, brain aneurysm clips).
  • Has any condition in which a gadolinium-contrast MRI is contraindicated (e.g., sickle cell anemia, renal failure).
  • Is mentally incompetent. If questionable, obtain psychiatric consult.
  • Has a 'Waddell Signs of Inorganic Behavior' score of 3 or greater.
  • Is a prisoner.
  • Is a tobacco user who does not agree to suspend tobacco use prior to surgery.
  • Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse.
  • Has received treatment with an investigational therapy (drug, device and/or biologic) within 28 days prior to implantation surgery or such treatment is planned during the 24-month period following the study surgery.
  • Is pregnant or nursing. Female of child-bearing potential must agree not to become pregnant for one year following surgery.
  • Is a Worker's Compensation case or is involved in spinal litigation.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Fort Wayne Orthopaedics

    Fort Wayne, Indiana, 46804

  • Andrews Institute

    Gulf Breeze, Florida, 32561

  • USC Department of Neurological Surgery

    Los Angeles, California, 90033

  • Sonoran Spine Center

    Mesa, Arizona, 85202

  • UPMC Presbyterian

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: A Prospective, Multi-center, Pivotal Trial for INFUSE® Bone Graft With CAPSTONE® Spinal System and Posterior Supplemental Fixation to Treat 1- or 2-level Advanced Degenerative Disease of the Lumbosacral Spine For a TLIF Approach

This investigation will provide safety and effectiveness information on the use of INFUSE® Bone Graft with the CAPSTONE® Spinal System and CD HORIZON® Spinal System with a Transforaminal Lumbar Interbody Fusion (TLIF) surgical approach at one or two adjacent levels from L2-S1 to treat subjects with advanced degenerative disease of the lumbosacral spine.

Read the detailed description

The study is a prospective, multi-national study that compares INFUSE® Bone Graft (investigational group) to autogenous bone graft (control group). Control group subjects will receive the same surgical treatment except for the use of autogenous bone graft (from the iliac crest) instead of INFUSE® Bone Graft. All sites will follow a common Clinical Investigational Plan (CIP) that consists of the protocol and accompanying case report forms, risk analysis, investigator's agreement, subject informed consent, institutional review board (IRB) certification, labeling, and monitoring information.

Being tested
INFUSE Bone Graft, Iliac Crest Bone Graft
Keywords
advanced degenerative disease of the lumbosacral spine, lumbosacral spine, radiculopathy, degenerative instability, spondylolisthesis, retrolisthesis, lateral listhesis, spinal stenosis, disc herniation, INFUSE Bone Graft, CD HORIZON Spinal System, CAPSTONE Spinal System
Medical subject headings
Radiculopathy, Spondylolisthesis, Spinal Stenosis, Intervertebral Disc Displacement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INFUSE Bone GraftDevice

    Also called rhBMP-2/ACS, Dibotermin alfa

    Subjects enrolled in the investigational treatment group will receive surgical treatment with INFUSE® Bone Graft, the CAPSTONE® Spinal System, and posterior supplemental fixation (in this study the CD HORIZON® Spinal System). The investigational treatment will be implanted using a TLIF surgical approach.

  • Iliac Crest Bone GraftOther

    Also called Autograft

    Subjects enrolled in the control group will receive the same surgical treatment as the investigational group, including the CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System), except for the use of autogenous bone graft (from the iliac crest) instead of INFUSE® Bone Graft. A TLIF surgical approach will also be used for implanting the control treatment.

Study groups in NCT01415908
Study groupRoleWhat they receive
Control GroupActive comparatorNot described
Receives: Other: Iliac Crest Bone Graft
Investigational GroupExperimentalNot described
Receives: Device: INFUSE Bone Graft

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Overall Success

    Rate of overall success is reported as percent of subjects who met all of the following criteria:

    1. fusion at all treated levels (e.g., one level for a one level fusion and two levels for a two level fusion);
    2. pain/disability (Oswestry Disability Index) success;
    3. neurological status success;
    4. no serious adverse event classified as "implant associated" or "implant/surgical procedure associated";
    5. no additional surgical procedure classified as a "failure."

    Measured: 24 months

Secondary outcomes (10)

  1. Rate of Fusion Success

    Rate of fusion success is reported as percent of subjects having fusion success. The fusion success was defined radiologically as:

    1. evidence of bridging bone;
    2. no evidence of motion;
    3. no evidence of radiolucency at greater than 50% of the superior or inferior PEEK spacer-vertebra interface.

    Measured: 24 months

  2. Success Rate of Oswestry Disability Index

    ODI Questionnaire was used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability). Success rate of Oswestry Disability Index (ODI) is reported as percent of subjects whose ODI score met: pre-operative score - post-operative score ≥ 15.

    Measured: 24 months

  3. Success Rate of Neurological Status

    Neurological status was assessed in six sections: motor, sensory, reflexes, straight leg raising, bowel function, and bladder function. Each of the sections had a number of elements. Success rate of neurological status is reported as percent of subjects whose neurological status was maintained or improved in three key neurological assessments-motor, sensory, and deep tendon reflexes.

    Measured: 24 months

  4. Success Rate of Back Pain

    Numerical rating scales were used to evaluate back pain intensity and frequency. Subjects rated their back pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be." Similarly, subjects recorded their back pain frequency on a scale from 0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time." The total back pain score were the sum of pain intensity and frequency scores. Success rate of back pain is reported as percent of subjects whose back pain improvement met: pre-operative score - post-operative score > 0.

    Measured: 24 months

  5. Success Rate of Leg Pain

    Numerical rating scales were used to evaluate leg pain intensity and frequency. Subjects rated their leg pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be." Similarly, subjects recorded their leg pain frequency on a scale from 0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time." The total leg pain score were the sum of pain intensity and frequency scores. Success rate of leg pain is reported as percent of subjects whose leg pain improvement met: pre-operative score - post-operative score > 0.

    Measured: 24 months

  6. Success Rate of General Health Status

    The Medical Outcomes Study 36-Item Short Form (SF-36) health survey was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The scores for PCS and MCS are between 0 and 100, with higher scores denoting better quality of life. To be classified as a success, the following criteria must be met for SF-36 PCS and MCS, respectively: post-operative score - pre-operative score >= 0. The results are reported as percent of subjects who have SF-36 PCS success, SF-36 MCS success, and overall SF-36 success.

    Measured: 24 months

  7. Percent of Subjects Who Had Additional Surgical Procedures/Interventions

    Measured: 24 months

  8. Operative Time

    Measured: Operative time was recorded from skin incision to wound closure

  9. Blood Loss

    Measured: During the operation, an average of 200 minutes for investigational group and 281.5 minutes for control group

  10. Hospital Stay

    Measured: During the time of hospital stay

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionSep 2014
  4. Study completionJan 2015

Why it stopped: Due to study design challenges including DMC enrollment suspension as required by the protocol stopping rules and recommended changes to the surgical technique

Resources

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 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01415908
Sponsor's protocol ID
Medtronic P05-06
Acronym
TLIF
Status last verified
Jan 2016
First submitted
10 Aug 2011
Last updated
18 Feb 2016
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing INFUSE Bone Graft and Iliac Crest Bone Graft in people with Lumbar Spine Degeneration, run by Medtronic Spinal and Biologics at 5 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 11 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: stopped early, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Rate of Overall Success (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01415908.

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 Feb 2016.

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