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Evaluate Effectiveness of the Biomet Lumbar Spinal Fusion System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00758719
Recruitment Status : Completed
First Posted : September 25, 2008
Last Update Posted : February 29, 2016
Information provided by (Responsible Party):
Zimmer Biomet

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

Condition or disease
Degenerative Disc Disease

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

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Study Type : Observational
Actual Enrollment : 53 participants
Time Perspective: Prospective
Official Title: A Prospective Multicenter Lumbar Spine Fusion Study to Evaluate the Effectiveness of the Biomet Lumbar Spinal Fusion System
Study Start Date : September 2008
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Radiographic Fusion [ Time Frame: 12 Month ]

Secondary Outcome Measures :
  1. Mean VAS % change from baseline [ Time Frame: 24 Months ]
  2. Oswestry Disability Index % change from baseline [ Time Frame: 24 Month ]
  3. Neurologic Assessment, Maintenance or improvement from baseline [ Time Frame: 12 Month ]
  4. SF-36 % change from baseline [ Time Frame: 24 Month ]
  5. Return to work [ Time Frame: 24 month ]
  6. Return to normal activity [ Time Frame: 24 month ]
  7. Narcotic Usage, pre and post-operatively [ Time Frame: 24 month ]
  8. Serious Surgical Complications [ Time Frame: 24 month ]
  9. Clinical Success [ Time Frame: 24 month ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00758719

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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
Zimmer Biomet
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Study Director: Joel Batts Biomet Spine

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Responsible Party: Zimmer Biomet Identifier: NCT00758719     History of Changes
Other Study ID Numbers: CS-045
First Posted: September 25, 2008    Key Record Dates
Last Update Posted: February 29, 2016
Last Verified: September 2012
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Zimmer Biomet:
Spinal Fusion

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