Lumbar Spinal Fusion System - Full Text View

Sponsor:	Biomet, Inc.
Information provided by:	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00758719

Purpose

The purpose of this study is to evaluate the effectiveness of the Biomet Lumbar Spinal Fusion System in patients undergoing lumbar fusion surgery.

Condition
Degenerative Disc Disease

Study Type:	Observational
Study Design:	Prospective
Official Title:	A Prospective Multicenter Lumbar Spine Fusion Study to Evaluate the Effectiveness of the Biomet Lumbar Spinal Fusion System

Resource links provided by NLM:

MedlinePlus related topics: Surgery

U.S. FDA Resources

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:

Radiographic Fusion [ Time Frame: 12 Month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mean VAS % change from baseline [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
Oswestry Disability Index % change from baseline [ Time Frame: 24 Month ] [ Designated as safety issue: No ]
Neurologic Assessment, Maintenance or improvement from baseline [ Time Frame: 12 Month ] [ Designated as safety issue: Yes ]
SF-36 % change from baseline [ Time Frame: 24 Month ] [ Designated as safety issue: No ]
Return to work [ Time Frame: 24 month ] [ Designated as safety issue: No ]
Return to normal activity [ Time Frame: 24 month ] [ Designated as safety issue: No ]
Narcotic Usage, pre and post-operatively [ Time Frame: 24 month ] [ Designated as safety issue: No ]
Serious Surgical Complications [ Time Frame: 24 month ] [ Designated as safety issue: Yes ]
Clinical Success [ Time Frame: 24 month ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	480
Study Start Date:	September 2008
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Detailed Description:

All subjects enrolled in this study will receive the The Biomet Osteobiologic Treatment System which is comprised of the SpF® Spine Fusion Stimulator and any or all of the following can be utilized in the study: any Pedicle Screw System, a Biomet Biologic Agent and an Interbody Spacer

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

This study is open to all patients with one or two level Degenerative Disease who are between the ages of 18 and 75.

Criteria

Inclusion Criteria:

The subject must, in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent.
The subject must be diagnosed with DDD at up to 2 levels from L2-S1 inclusive and undergoing up to 2 level lumbar spinal fusion surgery.
Subjects must be between 18 and 75 years of age.
The patient must be skeletally mature (epiphyses closed).

Exclusion Criteria:

Subject is pregnant, lactating or interested in becoming pregnant during the duration of the study.
Any active litigation.
Subject is currently involved in another investigational study.
Subject has a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the investigator's opinion may interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up.
Subject is incarcerated.
More than 2 prior spine surgeries/revision surgeries or any previous spinal fusions at levels being currently treated.
Traumatic instability.
Any parathyroid or metabolic bone disease.
Any active malignancy.
Osteopenia/Osteoporosis - All subjects will be screened for osteoporosis using SCORE (Simple Calculated Osteoporosis Risk Estimation) with a threshold value of 6. All subjects with a SCORE value greater than 6 will be referred for DEXA Scan. Subjects with a T-Score of £-1-2.5 will be excluded.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00758719

Contacts

Contact: John Evangelista, MD

973-299-9300 ext 3930

john.evangelista@ebimed.com

Locations

United States, Indiana
Union Hospital Neurosurgical	Recruiting
Terre Haute, Indiana, United States, 47807
Contact: Angie Lindley 812-238-4555 alindley@uhhg.org
Principal Investigator: Pradeep Narotam, MD
United States, Michigan
Family Orthopedic Associates	Recruiting
Flint, Michigan, United States, 48507
Contact: Kathy Shire 810-733-1200 KShire@power-net.net
Principal Investigator: David Fernandez, MD
United States, New York
New York Neurosurgical, PLLC	Recruiting
Fishkill, New York, United States, 12524
Contact: Jessie Saa 845-896-9200 jsaa024@yahoo.com
Principal Investigator: Steven Jacobs, MD
United States, Ohio
Orthopedics and Neurological Consultants, Inc	Recruiting
Columbus, Ohio, United States, 43212
Contact: Courtney Cribbs 614-839-2165 buckeye92177@yahoo.com
Principal Investigator: Ying Chen, MD
United States, Pennsylvania
South Hills Orthopedics	Recruiting
Pittsburgh, Pennsylvania, United States, 15243
Contact: Jessica Black 412-429-0880 jblack@shosa.org
Principal Investigator: Eric Nabors, MD
United States, Wisconsin
Neurological Associates of Waukesha	Recruiting
Waukesha, Wisconsin, United States, 53188
Contact: Anjulie Cerillo 262-542-9503 anjuli@neurologicltd.com
Principal Investigator: Andrew Beykovski, MD
Sub-Investigator: Kenneth Reichert, MD
Sub-Investigator: Christopher King, DO
Sub-Investigator: Lynn M Bartyl, MD

Sponsors and Collaborators

Biomet, Inc.

Investigators

Study Chair:

John Evangelsita, MD

EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing

More Information

No publications provided

Responsible Party:	Biomet ( Betsy Lowry, Senior CRA, Supervisor Clinical Data Entry )
Study ID Numbers:	CS-045
Study First Received:	September 9, 2008
Last Updated:	December 7, 2009
ClinicalTrials.gov Identifier:	NCT00758719 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Biomet, Inc.:

Spinal Fusion
DDD

Additional relevant MeSH terms:

Spinal Diseases
Musculoskeletal Diseases
Bone Diseases

ClinicalTrials.gov processed this record on February 08, 2010