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

This study has suspended participant recruitment.
(Sponsor decision to place on hold.)
Sponsor:
Information provided by (Responsible Party):
Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier:
NCT01415908
First received: August 10, 2011
Last updated: September 12, 2014
Last verified: September 2014
  Purpose

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. These data will be used to seek regulatory approval for the use of INFUSE® Bone Graft for this indication.


Condition Intervention Phase
Lumbar Spine Degeneration
Device: INFUSE Bone Graft
Other: Iliac Crest Bone Graft
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Medtronic Spinal and Biologics:

Primary Outcome Measures:
  • Overall Success [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

    A subject will be considered an overall success if all of the following conditions are met:

    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 per the ISO definition of "serious;"
    5. no additional surgical procedure classified as a "failure."


Secondary Outcome Measures:
  • Radiographic Fusion [ Time Frame: 24 months ] [ Designated as safety issue: No ]

    Fusion success is defined radiographically 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.

  • Pain/Disability Status [ Time Frame: 24 months ] [ Designated as safety issue: No ]

    The self-administered Oswestry Disability Index will be used. Success will be defined as pain/disability improvement postoperatively according to the following definition:

    Preoperative Score - Postoperative Score >= 15 points


  • Neurological Status [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Neurological status is based on six types of measurements: motor, sensory, reflexes, straight leg raising, bowel function, and bladder function. Each of the sections is comprised of a number of elements.Overall neurological success will be defined as maintenance or improvement in the three key neurological assessments—motor and sensory examinations and deep tendon reflexes.

  • Pain Status (Back Pain and Leg Pain) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Numerical rating scales will be used to evaluate pain intensity and duration. The pain score (0 min, 20 Max) is derived by adding the numerical rating scores from the pain intensity (0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be.") and duration scales (0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time"). Success for back and leg pain is described as follows: Preoperative Score - Postoperative Score >0

  • General Health Status [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) will be used to assess general health status. The SF-36 results can be summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). To be classified as a success, the following criteria must be met for SF-36 PCS and MCS, respectively: PCSPostop - PCSPreop >= 0; MCSPostop - MCSPreop >= 0

  • Additional Surgical Procedures/Interventions [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Surgery and Hospitalization Information [ Time Frame: At the time of discharge ] [ Designated as safety issue: No ]
    Surgery and hospitalization information includes operative time, blood loss, and number of hospital days.


Estimated Enrollment: 534
Study Start Date: July 2011
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control Group Other: Iliac Crest Bone Graft
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.
Other Name: Autograft
Experimental: Investigational Group Device: INFUSE Bone Graft
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.
Other Name: rhBMP-2/ACS

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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:

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01415908

Locations
United States, Arizona
Sonoran Spine Center
Mesa, Arizona, United States, 85202
United States, California
USC Department of Neurological Surgery
Los Angeles, California, United States, 90033
United States, Florida
Andrews Institute
Gulf Breeze, Florida, United States, 32561
United States, Indiana
Fort Wayne Orthopaedics
Fort Wayne, Indiana, United States, 46804
United States, Pennsylvania
UPMC Presbyterian
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Medtronic Spinal and Biologics
  More Information

No publications provided

Responsible Party: Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier: NCT01415908     History of Changes
Other Study ID Numbers: Medtronic P05-06
Study First Received: August 10, 2011
Last Updated: September 12, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Canada: Health Canada
Canada: Ethics Review Committee

Keywords provided by Medtronic Spinal and Biologics:
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

Additional relevant MeSH terms:
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases

ClinicalTrials.gov processed this record on September 29, 2014