Evaluate Effectiveness of the Biomet Lumbar Spinal Fusion System

Completed

Conditions studied: Degenerative Disc Disease

In brief

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

Key facts

Study ID

NCT00758719

Run by

Zimmer Biomet

People needed

53

Starts

2008-09-01

Expected to finish

2012-08-01

Last updated by the study team

2020-02-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.