Study Performance of The Plexur P™ Bone Void Filler Device in Patients Undergoing Iliac Crest Harvesting Procedures

Completed · Not applicable

Conditions studied: Iliac Crest Harvesting Procedure-Bone Void Filler

In brief

The purpose of this study is to determine if Plexur P grows bone in the iliac crest (where bone was removed or "harvested") for the back surgery. The study will be focusing on patients who require back surgery. Often additional bone is required from the hip of the patient (iliac crest). When bone removed from the hip, a "void" is often created. This "void" will be filled in with Osteotech's Plexur P product.

Key facts

Study ID

NCT00837473

Run by

Osteotech, Inc

People needed

15

Starts

2009-01-01

Expected to finish

2011-10-01

Last updated by the study team

2018-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The patient is at least 18 yrs old.
• The patient requires an iliac crest harvesting procedure.
• The patient has signed an Informed Consent, approved by the IRB.

You may not qualify if…

• Patient is less than 18 years old.
• Patient presents with a bony void or gap in an area other than the iliac crest and/or has an infection present at the (operative) site.
• Insulin dependent diabetics and/or in the opinion of the investigator, has poorly controlled non-insulin dependent diabetes.
• The patient is a smoker.
• The patient is mentally compromised (e.g., currently being treated from a psychiatric disorder, senile dementia, Alzheimer's disease, etc.) and/or in the opinion of the investigator, is not likely to complete follow up visits;
• The patient has a bleeding disorder of any etiology, severe vascular or neurological disease;
• The patient has hypercalcemia and/or severe degenerative bone disease;
• The patient has a history of long term steroid use;
• The patient requires immunosuppressive therapy;
• The patient has a history of drug or alcohol abuse that may interfere with his/her ability to provide written informed consent;
• The patient is pregnant at the time of study entry or may likely become pregnant during the course of study participation;
• The subject has an implanted device, which is incompatible with the use of imaging equipment;
• The patient has an allergy to one of the components of the investigational device;
• The patient has renal insufficiency;
• The patient has a terminal illness.

Where it is running

• Hospital for Special Surgery — New York, New York, United States

Full record on ClinicalTrials.gov

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