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

NCT01415908 | Terminated Phase 3 Results DMC

• 1 other identifier: Medtronic P05-06
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 5

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.

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

Outcome Measures

Primary Outcomes (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."

  24 months

Secondary Outcomes (10)

• Rate of Fusion Success

  24 months

• Success Rate of Oswestry Disability Index

  24 months

• Success Rate of Neurological Status

  24 months

• Success Rate of Back Pain

  24 months

• Success Rate of Leg Pain

  24 months

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Other: Iliac Crest Bone Graft

Investigational Group

EXPERIMENTAL

Device: INFUSE Bone Graft

Interventions

INFUSE Bone Graft 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.

Also known as: rhBMP-2/ACS, Dibotermin alfa

Investigational Group

Iliac Crest Bone Graft 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.

Also known as: Autograft

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Medtronic Spinal and Biologics: lead

Study Sites (5)

Sonoran Spine Center

Mesa, Arizona, 85202, United States

Location

USC Department of Neurological Surgery

Los Angeles, California, 90033, United States

Location

Andrews Institute

Gulf Breeze, Florida, 32561, United States

Location

Fort Wayne Orthopaedics

Fort Wayne, Indiana, 46804, United States

Location

UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Radiculopathy; Spondylolisthesis; Spinal Stenosis; Intervertebral Disc Displacement

Interventions

Transplantation, Autologous

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Limitations and Caveats

A total of 534 ± 10 subjects were planned for enrollment. However, this study was terminated early with only 15 enrolled patients, leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Clinical Department
• Organization: Medtronic Spinal and Biologics

msbkclinicalresearch@medtronic.com

1800-876-3133

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2011
• First Posted: August 12, 2011
• Study Start: July 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: January 1, 2015
• Last Updated: February 18, 2016
• Results First Posted: October 28, 2015

Record last verified: 2016-01

Locations

US (5)