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

NCT ID: NCT01415908

Last Updated: 2016-02-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2015-01-31

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.

Conditions

Lumbar Spine Degeneration

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control Group

Group Type: ACTIVE_COMPARATOR

Iliac Crest Bone Graft

Intervention Type: OTHER

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.

Investigational Group

Group Type: EXPERIMENTAL

INFUSE Bone Graft

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Other Intervention Names

rhBMP-2/ACS; Dibotermin alfa; Autograft

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Spinal and Biologics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sonoran Spine Center

Mesa, Arizona, United States

USC Department of Neurological Surgery

Los Angeles, California, United States

Andrews Institute

Gulf Breeze, Florida, United States

Fort Wayne Orthopaedics

Fort Wayne, Indiana, United States

UPMC Presbyterian

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

Medtronic P05-06

Identifier Type: -

Identifier Source: org_study_id