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INFUSE®Bone Graft in Transforaminal Lumbar Interbody Fusion for Degenerative Disease of Lumbosacral Spine | Clinical Trials | Clareo Health

TERMINATEDPHASE3

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

NCT01415908•Medtronic Spinal and Biologics

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

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.
+22 more criteria

Locations (5)

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

Key Dates

Start Date

July 1, 2011

Primary Completion Date

September 1, 2014

Completion Date

January 1, 2015

Last Updated

February 18, 2016

Enrollment

ACTUAL participants

Conditions

Lumbar Spine Degeneration

Interventions

INFUSE Bone Graft

DEVICE

Iliac Crest Bone Graft

OTHER

OpalGenix- Personalized Postoperative Pain Management Following Lumbar Spinal Fusion and Decompression Surgery in Adults

NCT05452694

Lumbar Spine StenosisLumbar Spine Degeneration

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COMPLETEDNA

LLIF Plus Posterior Decompression for Severe Lumbar Spinal Stenosis

NCT04094220

Lumbar Spine DegenerationLumbar Spinal Stenosis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 18, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

OpalGenix- Personalized Postoperative Pain Management Following Lumbar Spinal Fusion and Decompression Surgery in Adults

LLIF Plus Posterior Decompression for Severe Lumbar Spinal Stenosis

The Six-Minute Walking Test (6MWT) as a Measure of Functional Impairment in Lumbar Degenerate Disc Disease.

A Prospective, Multicenter Observational Study on MAST™ (Minimal Access Spinal Technologies) Fusion Procedures for the Treatment of the Degenerative Lumbar Spine