A Pilot Prospective Randomized Clinical Investigation of INFUSE® Bone Graft and MASTERGRAFT® Granules With the CD HORIZON® Spinal System for Posterolateral Lumbar Fusion in Patients With Symptomatic Degenerative Disc Disease

Medtronic Spinal and Biologics0 sites46 target enrollmentApril 2003

ConditionsDegenerative Disc Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: Degenerative Disc Disease
Sponsor: Medtronic Spinal and Biologics
Enrollment: 46
Primary Endpoint: Overall Success
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The purpose of this pilot clinical trial is to evaluate the feasibility of using the investigational implant (INFUSE® Bone Graft and MASTERGRAFT® Granules with the CD HORIZON® Spinal System) as a method of facilitating spinal fusion in patients with symptomatic degenerative disc disease.

Registry

clinicaltrials.gov

Start Date

April 2003

End Date

March 2007

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Medtronic Spinal and Biologics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Has degenerative disc disease as noted by back pain of discogenic origin, with or without leg pain, with degeneration of the disc confirmed by patient history (e.g., pain \[leg, back, or symptoms in the sciatic nerve distribution\], functional deficit and/or neurological deficit) and radiographic studies (e.g.,C T, MRl, X-Ray,etc.) to include one or more of the following:
•instability (defined as angulation ≥ 5° and/or translation ≥ 4mm,based on flexion/extension radiographs);
•osteophyte formation;
•decreased disc height;
•thickening of ligamentous tissue;
•disc degeneration or herniation; and/or
•facet joint degeneration.
•Has preoperative Oswestry score ≥
•Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's Classification (Meyerding HW,1932).
•Requires fusion of a single level disc space from L1 to S

Exclusion Criteria

•Has primary diagnosis of a spinal disorder other than degenerative disc disease with Grade 1 or less spondylolisthesis at the involved level.
•Had previous spinal fusion surgical procedure at the involved level or an adjacent level.
•Requires spinal fusion at more than one lumbar level.
•Has a condition which requires postoperative medications that interfere with fusion, such as steroids or prolonged use of nonsteroidal anti-inflammatory drugs. This does not include low dose aspirin for prophylactic anticoagulation.
•Has a documented history of osteopenia or osteomalacia.
•Has any of the following that may be associated with diagnosis of osteoporosis (if "Yes" to any of the below risk factors,a dual x-ray absorptiometry (DEXA) scan will be required to determine eligibility.)
•Postmenopausal non-black female over 60 years of age and weighs less than 140 pounds.
•Postmenopausal female that has sustained a non-traumatic hip, spine, or wrist fracture.
•Male over the age of
•Male over the age of 60 that has sustained a non-traumatic hip or spine fracture. If the level of BMD is a T score of -3.5 or a T score of -2.5 with vertebral crush fracture,then the patient is excluded from the study.

Outcomes

Primary Outcomes

Overall Success

Time Frame: 24 months

A patient will be considered an overall success if all of the following conditions are met: 1. Fusion; 2. Postoperative Oswestry score improvement of at least 15% from preoperative; 3. Maintenance or improvement in neurological status; 4. No serious adverse event classified as implant associated or implant surgical procedure associated; 5. No additional surgical procedure classified as a "failure".