Evaluate Effectiveness of the Biomet Lumbar Spinal Fusion System

NCT00758719 | Completed

• 1 other identifier: CS-045
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 4

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.

Conditions

Degenerative Disc Disease

Keywords

Spinal Fusion; Degenerative Disc Disease

Outcome Measures

Primary Outcomes (1)

• Radiographic Fusion

  12 Month

Secondary Outcomes (7)

• Visual Analog Scale (VAS) change from baseline

  24 Months

• 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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (4)

Union Hospital Neurosurgical

Terre Haute, Indiana, 47807, United States

Location

Family Orthopedic Associates

Flint, Michigan, 48507, United States

Location

Orthopedics and Neurological Consultants, Inc

Columbus, Ohio, 43212, United States

Location

Neurological Associates of Waukesha

Waukesha, Wisconsin, 53188, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Joel Batts

  Biomet Spine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2008
• First Posted: September 25, 2008
• Study Start: September 1, 2008
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: February 24, 2020

Record last verified: 2020-02

Locations

US (4)