Clinical trial NCT00837473: Study Performance of The Plexur P™ Bone Void Filler Device in Patients Undergoing Iliac Crest Harvesting Procedures
Official title: A Prospective Pilot Study on the Performance of The Plexur P™ Bone Void Filler
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iliac Crest Harvesting Procedure-Bone Void Filler
Keywords: Bone Void Filler
Iliac Crest Bone Void Filler
Back Surgery and Autograft Bone
Autograft Bone
Allograft Bone
Lead sponsor: Medtronic Spinal and Biologics
Sponsor class: INDUSTRY
First posted: 2009-02-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Reconstitution of Bone Growth in the Iliac Crest Bone Void Determined by an Independent Radiologist
timeFrame: 6 wks, 3 mths, 6 mths 12 mths, and 24 mths
Secondary outcomes:
measure: General Health Status
timeFrame: Baseline, 6 wks, 3 mths, 6 mths, 12 mths, and 24 mths
measure: Oswestry Disability Index
timeFrame: Baseline, 6 wks, 3 mths, 6 mths, 12 mths, and 24 mths
measure: Pain Status Assessed by Visual Analog Scale (VAS)
timeFrame: Baseline, 6 wks, 3 mths, 6 mths, 12 mths, and 24 mths
measure: Surgical Related Outcome--locations of Iliac Crest Bone Harvest
timeFrame: During the time of operation, a range of 2.5-8.5 hrs
measure: Surgical outcome-the Amount of Cancellous Bone Harvested
timeFrame: During the time of operation, a range of 2.5-8.5 hrs
measure: Surgical Outcome--operative Time
timeFrame: The time of operation, a range of 2.5-8.5 hrs
measure: Surgical Outcome--blood Loss
timeFrame: During the time of operation, a range of 2.5-8.5 hrs
measure: Surgical Outcome--length of Hospital Stay
timeFrame: From admission to discharge, a range of 2 to 20 days
measure: Surgical Outcome- the Amount of Plexur™ P Product Utilized for Filling Void
timeFrame: During the time of operation, a range of 2.5-8.5 hrs
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Oheneba Boachie-Adijei, MD
role: PRINCIPAL_INVESTIGATOR
References: