Clinical trial NCT01415908: INFUSE®Bone Graft in Transforaminal Lumbar Interbody Fusion for Degenerative Disease of Lumbosacral Spine
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Lumbar Spine Degeneration
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
Lead sponsor: Medtronic Spinal and Biologics
Sponsor class: INDUSTRY
First posted: 2011-08-12
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 degenerative disease of the lumbosacral spine.

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 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.

Primary outcomes:
measure: Rate of Overall Success
timeFrame: 24 months
Secondary outcomes:
measure: Rate of Fusion Success
timeFrame: 24 months
measure: Success Rate of Oswestry Disability Index
timeFrame: 24 months
measure: Success Rate of Neurological Status
timeFrame: 24 months
measure: Success Rate of Back Pain
timeFrame: 24 months
measure: Success Rate of Leg Pain
timeFrame: 24 months
measure: Success Rate of General Health Status
timeFrame: 24 months
measure: Percent of Subjects Who Had Additional Surgical Procedures/Interventions
timeFrame: 24 months
measure: Operative Time
timeFrame: Operative time was recorded from skin incision to wound closure
measure: Blood Loss
timeFrame: During the operation, an average of 200 minutes for investigational group and 281.5 minutes for control group
measure: Hospital Stay
timeFrame: During the time of hospital stay
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Sonoran Spine Center
state: Arizona
city: Los Angeles
country: United States
facility: USC Department of Neurological Surgery
state: California
city: Gulf Breeze
country: United States
facility: Andrews Institute
state: Florida
city: Fort Wayne
country: United States
facility: Fort Wayne Orthopaedics
state: Indiana
city: Pittsburgh
country: United States
facility: UPMC Presbyterian
state: Pennsylvania
Study officials:
References: