Status:
COMPLETED
Study Performance of The Plexur P™ Bone Void Filler Device in Patients Undergoing Iliac Crest Harvesting Procedures
Lead Sponsor:
Osteotech, Inc
Conditions:
Iliac Crest Harvesting Procedure-Bone Void Filler
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ba...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00837473
Start Date
January 1 2009
End Date
October 1 2011
Last Update
April 30 2018
Active Locations (1)
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1
Hospital for Special Surgery
New York, New York, United States, 10021