Evaluate Effectiveness of the Biomet Lumbar Spinal Fusion System

Completed

• Conditions: Degenerative Disc Disease

• Registration Number: NCT00758719
• Lead Sponsor: 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.

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

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-09
• Study First Submitted QC: 2008-09-23
• Study First Posted: 2008-09-25
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-20
• Last Update Posted: 2020-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Radiographic Fusion	12 Month

Secondary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS) change from baseline	24 Months	Mean VAS % change from baseline
Oswestry Disability Index change from baseline	24 Month	Oswestry Disability Index % change from baseline
Neurologic Assessment, Maintenance or improvement from baseline	12 Month
Time to return to normal activity	24 month
Short Form Health Survey (SF-36) % change from baseline	24 Month
Narcotic Use	24 month	pre and post-operatively
Time to return to work	24 month

Trial Locations

Locations (4)

Union Hospital Neurosurgical; 🇺🇸 Terre Haute, Indiana, United States

Family Orthopedic Associates; 🇺🇸 Flint, Michigan, United States

Orthopedics and Neurological Consultants, Inc; 🇺🇸 Columbus, Ohio, United States

Neurological Associates of Waukesha; 🇺🇸 Waukesha, Wisconsin, United States