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

August 10, 2011
September 12, 2014
July 2011
July 2015   (final data collection date for primary outcome measure)
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."
Same as current
Complete list of historical versions of study NCT01415908 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
  • Pain Status [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Numerical rating scales will be used to evaluate back and leg pain intensity and frequency.
Not Provided
Not Provided
 
INFUSE®Bone Graft in Transforaminal Lumbar Interbody Fusion for Degenerative Disease of Lumbosacral Spine
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. These data will be used to seek regulatory approval for the use of INFUSE® Bone Graft for this indication.

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Lumbar Spine Degeneration
  • 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
  • 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
  • Active Comparator: Control Group
    Intervention: Other: Iliac Crest Bone Graft
  • Experimental: Investigational Group
    Intervention: Device: INFUSE Bone Graft
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
534
July 2017
July 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01415908
Medtronic P05-06
Yes
Medtronic Spinal and Biologics
Medtronic Spinal and Biologics
Not Provided
Not Provided
Medtronic Spinal and Biologics
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP