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OpenTrials
Completed

NCT Number: NCT00758719

Evaluate Effectiveness of the Biomet Lumbar Spinal Fusion System

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Union Hospital Neurosurgical, Terre Haute, Indiana, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 degenerative disc disease 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.
  • 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 Dual-energy X-ray absorptiometry (DEXA) Scan. Subjects with a T-Score of £-1-2.5 will be excluded.

Treatment and study plan

Primary outcomes

  1. Radiographic Fusion

    Time frame: 12 Month

Secondary outcomes

  1. Visual Analog Scale (VAS) change from baseline

    Time frame: 24 Months

    Mean VAS % change from baseline

  2. Oswestry Disability Index change from baseline

    Time frame: 24 Month

    Oswestry Disability Index % change from baseline

  3. Neurologic Assessment, Maintenance or improvement from baseline

    Time frame: 12 Month

  4. Short Form Health Survey (SF-36) % change from baseline

    Time frame: 24 Month

  5. Time to return to work

    Time frame: 24 month

  6. Time to return to normal activity

    Time frame: 24 month

  7. Narcotic Use

    Time frame: 24 month

    pre and post-operatively

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Registry information

Official study title

A Prospective Multicenter Lumbar Spine Fusion Study to Evaluate the Effectiveness of the Biomet Lumbar Spinal Fusion System

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Sep 25, 2008
Registry last updated
Feb 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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