Clinical trial NCT00758719: Evaluate Effectiveness of the Biomet Lumbar Spinal Fusion System
Official title: A Prospective Multicenter Lumbar Spine Fusion Study to Evaluate the Effectiveness of the Biomet Lumbar Spinal Fusion System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Disc Disease
Keywords: Spinal Fusion
Degenerative Disc Disease
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Radiographic Fusion
timeFrame: 12 Month
Secondary outcomes:
measure: Visual Analog Scale (VAS) change from baseline
timeFrame: 24 Months
measure: Oswestry Disability Index change from baseline
timeFrame: 24 Month
measure: Neurologic Assessment, Maintenance or improvement from baseline
timeFrame: 12 Month
measure: Short Form Health Survey (SF-36) % change from baseline
timeFrame: 24 Month
measure: Time to return to work
timeFrame: 24 month
measure: Time to return to normal activity
timeFrame: 24 month
measure: Narcotic Use
timeFrame: 24 month
Other outcomes:
Locations:
city: Terre Haute
country: United States
facility: Union Hospital Neurosurgical
state: Indiana
city: Flint
country: United States
facility: Family Orthopedic Associates
state: Michigan
city: Columbus
country: United States
facility: Orthopedics and Neurological Consultants, Inc
state: Ohio
city: Waukesha
country: United States
facility: Neurological Associates of Waukesha
state: Wisconsin
Study officials:
affiliation: Biomet Spine
name: Joel Batts
role: STUDY_DIRECTOR
References: