Evaluate Effectiveness of the Biomet Lumbar Spinal Fusion System

Degenerative Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00758719
• Other study ID #: CS-045
• Status: Completed
• Start date: September 2008
• Est. completion date: August 2012

Study information

• Verified date: February 2020
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Locations

Country	Name	City	State
United States	Orthopedics and Neurological Consultants, Inc	Columbus	Ohio
United States	Family Orthopedic Associates	Flint	Michigan
United States	Union Hospital Neurosurgical	Terre Haute	Indiana
United States	Neurological Associates of Waukesha	Waukesha	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic Fusion		12 Month
Secondary	Visual Analog Scale (VAS) change from baseline	Mean VAS % change from baseline	24 Months
Secondary	Oswestry Disability Index change from baseline	Oswestry Disability Index % change from baseline	24 Month
Secondary	Neurologic Assessment, Maintenance or improvement from baseline		12 Month
Secondary	Short Form Health Survey (SF-36) % change from baseline		24 Month
Secondary	Time to return to work		24 month
Secondary	Time to return to normal activity		24 month
Secondary	Narcotic Use	pre and post-operatively	24 month