A Pilot, Prospective, Non-Randomized Clinical Investigation of TELAMON P™ Implant With INFUSE® Bone Graft and the CD HORIZON® Spinal System for Posterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease

Medtronic Spinal and Biologics0 sites30 target enrollmentJuly 2003

ConditionsDegenerative Disc Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Degenerative Disc Disease
Sponsor: Medtronic Spinal and Biologics
Enrollment: 30
Primary Endpoint: Overall Success
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The purpose of this pilot study is to evaluate the feasibility of the implant ( TELAMON P™ Implant/INFUSE Bone Graft System used in conjunction with the CD HORIZON® Spinal System) as a method of facilitating lumbar spinal fusion utilizing a posterior surgical approach in patients with symptomatic degenerative disc disease. The safety and effectiveness of the implant will be evaluated.

Registry

clinicaltrials.gov

Start Date

July 2003

End Date

October 2008

Last Updated

7 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 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 (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 preoperative back pain score of \>= 25 based on the Preoperative Back and Leg Pain Questionnaire (intensity and duration).
•Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's Classification (Meyerding, HW, 1932).

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.
•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 excluding routine peri-operative nonsteroidal anti-inflammatory drugs. This does not include low dose aspirin for prophylactic anticoagulation.
•Has been previously diagnosed with osteopenia or osteomalacia.
•Has any of the following that may be associated with a 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, the patient is excluded from the study.

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) 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".