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Lumbar Spinal Fusion System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT00758719
First received: September 9, 2008
Last updated: September 19, 2012
Last verified: September 2012
History of Changes
  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: Time Perspective: Prospective
Official Title: A Prospective Multicenter Lumbar Spine Fusion Study to Evaluate the Effectiveness of the Biomet Lumbar Spinal Fusion System

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 ]

Enrollment: 53
Study Start Date: September 2008
Study Completion Date: August 2012
Primary Completion Date: August 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, autograft 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:

  1. 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.
  2. The subject must be diagnosed with DDD at up to 2 levels from L2-S1 inclusive and undergoing up to 2 level posterior lumbar spinal fusion surgery with or without anterior column fusion.
  3. Subjects must be between 18 and 75 years of age.
  4. The patient must be skeletally mature (epiphyses closed).

Exclusion Criteria:

  1. Subject is pregnant, lactating or interested in becoming pregnant during the duration of the study.
  2. Any active litigation.
  3. Subject is currently involved in another investigational study.
  4. 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.
  5. Subject is incarcerated.
  6. More than 2 prior spine surgeries/revision surgeries or any previous spinal fusions at levels being currently treated.
  7. Traumatic instability.
  8. Any parathyroid or metabolic bone disease.
  9. Any active malignancy.
  10. 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

Locations
United States, Indiana
Union Hospital Neurosurgical
Terre Haute, Indiana, United States, 47807
United States, Michigan
Family Orthopedic Associates
Flint, Michigan, United States, 48507
United States, Ohio
Orthopedics and Neurological Consultants, Inc
Columbus, Ohio, United States, 43212
United States, Wisconsin
Neurological Associates of Waukesha
Waukesha, Wisconsin, United States, 53188
Sponsors and Collaborators
Biomet, Inc.
Investigators
Study Chair: Eileen Bridges EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing
  More Information

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT00758719     History of Changes
Other Study ID Numbers: CS-045
Study First Received: September 9, 2008
Last Updated: September 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Biomet, Inc.:
Spinal Fusion
DDD

Additional relevant MeSH terms:
Intervertebral Disk Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 19, 2013