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

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ClinicalTrials.gov Identifier: NCT00837473
Recruitment Status : Completed
First Posted : February 5, 2009
Last Update Posted : December 2, 2017
Information provided by (Responsible Party):
Medtronic Spinal and Biologics ( Osteotech, Inc )

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 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.

Condition or disease Intervention/treatment
Iliac Crest Harvesting Procedure-Bone Void Filler Device: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures

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 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Pilot Study on the Performance of The Plexur P™ Bone Void Filler
Study Start Date : January 2009
Primary Completion Date : March 2011
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Plexur-P Bone Void Filler
Single arm. Open Label.
Device: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures
Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures

Primary Outcome Measures :
  1. One outcome measure: "reconstitution" of bone growth in the iliac crest bone void (determined by an independent radiologist). [ Time Frame: Radiographs will be given in: 6 wks, 3 mths, 6 mths 12 mths. and 24 mths. An 18 month CT scan may be required based on independent radiolgist's review of 12 mth CT scan. ]

Secondary Outcome Measures :
  1. A secondary outcome will be a review of patient responses to questionnaires given at each post operative visit. [ Time Frame: Questionnaires will be given postoperatively in 6 wks, 3 mths, 6 mths, 12 mths, and 24 mths. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00837473

United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Osteotech, Inc
Principal Investigator: Oheneba Boachie-Adijei, MD Hospital for Special Surgery, New York

Responsible Party: Osteotech, Inc
ClinicalTrials.gov Identifier: NCT00837473     History of Changes
Other Study ID Numbers: Trial #3206
First Posted: February 5, 2009    Key Record Dates
Last Update Posted: December 2, 2017
Last Verified: September 2012

Keywords provided by Medtronic Spinal and Biologics ( Osteotech, Inc ):
Bone Void Filler
Iliac Crest Bone Void Filler
Back Surgery and Autograft Bone
Autograft Bone
Allograft Bone