Evaluate Effectiveness of the Biomet Lumbar Spinal Fusion System

A Prospective Multicenter Lumbar Spine Fusion Study to Evaluate the 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.

Study Overview

• Status: Completed
• Conditions: 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

• Study Type: Observational
• Enrollment (Actual): 53

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Terre Haute, Indiana, United States, 47807
      • Union Hospital Neurosurgical
  • Michigan
    • Flint, Michigan, United States, 48507
      • Family Orthopedic Associates
  • Ohio
    • Columbus, Ohio, United States, 43212
      • Orthopedics and Neurological Consultants, Inc
  • Wisconsin
    • Waukesha, Wisconsin, United States, 53188
      • Neurological Associates of Waukesha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Radiographic Fusion	12 Month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Joel Batts, Biomet Spine

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: September 9, 2008
• First Submitted That Met QC Criteria: September 23, 2008
• First Posted (Estimate): September 25, 2008

Study Record Updates

• Last Update Posted (Actual): February 24, 2020
• Last Update Submitted That Met QC Criteria: February 20, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Degenerative Disc Disease; Spinal Fusion
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: CS-045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED