Pilot Study of Recombinant Human Bone Morphogenetic Protein-2 and Compression Resistant Matrix With the CD HORIZON® Spinal System for Posterolateral Lumbar Fusion in Patients With Symptomatic DDD at Two Adjacent Vertebral Levels

Medtronic Spinal and Biologics0 sites29 target enrollmentJuly 2005

ConditionsDegenerative Disc Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: Degenerative Disc Disease
Sponsor: Medtronic Spinal and Biologics
Enrollment: 29
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 study is to evaluate the feasibility of using the investigational implant (rhBMP-2/CRM with the CD HORIZON® Spinal System) as a method of facilitating posterolateral lumbar spinal fusion at two adjacent treatment levels in patients with symptomatic degenerative disc disease.

Registry

clinicaltrials.gov

Start Date

July 2005

End Date

November 2010

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Medtronic Spinal and Biologics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Has degenerative disc disease at two adjacent lumbar levels as noted by back pain of discogenic origin, with or without leg pain, with degeneration of the disc confirmed by patient history and radiographic studies to include one or more of the following:
•instability;
•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) at either treatment level.
•Requires fusion at two adjacent lumbar levels 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 levels.
•Has had previous spinal fusion surgical procedure(s) at the involved levels.
•Requires spinal fusion at more than two lumbar levels.
•Has a condition that requires postoperative medications that interfere with fusion, such as steroids or prolonged use of nonsteroidal anti-inflammatory drugs, excluding routine perioperative nonsteroidal anti-inflammatory drugs. This does not include low dose aspirin for prophylactic anticoagulation.
•Has been previously diagnosed with osteopenia, osteomalacia, or osteoporosis, or has any of the following that may be associated with a diagnosis of osteoporosis. (If "Yes" to any of the criteria below, a dual x-ray absorptiometry \[DEXA\] scan will be required to determine eligibility.)
•Previously diagnosed with osteopenia, osteomalacia, or osteoporosis.
•Postmenopausal non-black female over 60 years of age who weighs less than 140 pounds.
•Postmenopausal female who has sustained a nontraumatic hip, spine, or wrist fracture.
•Male over the age of
•Male over the age of 60 who has sustained a nontraumatic hip or spine fracture. If the level of bone mineral density (BMD) is a T score of -3.5 or lower( i.e., -3.6, - 3.7, etc.) or a T score of -2.5 or lower( i.e., -2.6,

Outcomes

Primary Outcomes

Overall Success

Time Frame: 24 month

A patient will be considered an overall success if all of the following conditions are met: 1. fusion; 2. pain/disability (Oswestry) improvement; 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".