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

This prospective trial is designed to evaluate the ability of the Plexur P device (bone void filler) to reconstitute the iliac crest in patients requiring iliac crest bone harvesting procedures at one single study site.

Plexur P Bone Void Filler is:

• A biocomposite of mineralized cortical allograft bone fibers and polylactide-co-glycolide co-polymer.
• Designed to fill bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure.
• Porosity is introduced into the Plexur P Biocomposites to create a cancellous-like structure that provides a scaffold for bone growth.

In addition:

• Patients will be screened for study eligibility based on the need for iliac crest bone harvesting.
• Fifteen (15) eligible patients will be enrolled and will have an iliac crest harvesting defect backfilled with Plexur P to repair the iliac crest defect.
• As a part of routine follow up care, patient related outcomes including measurements of pain severity and pain relief will be determined using patient (IRB approved) questionnaires.
• Radiographic analysis will also be used to determine amount of bony ingrowth of the Plexur P device.

Inclusion criteria

• 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.

Exclusion criteria

• 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.