Study Performance of The Plexur P™ Bone Void Filler Device in Patients Undergoing Iliac Crest Harvesting Procedures
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.
|Iliac Crest Harvesting Procedure-Bone Void Filler||Device: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures||Phase 1|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective Pilot Study on the Performance of The Plexur P™ Bone Void Filler|
- 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. ]
- 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. ]
|Study Start Date:||January 2009|
|Study Completion Date:||October 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
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
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00837473
|United States, New York|
|Hospital for Special Surgery|
|New York, New York, United States, 10021|
|Principal Investigator:||Oheneba Boachie-Adijei, MD||Hospital for Special Surgery, New York|