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

Purpose

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	Intervention	Phase
Iliac Crest Harvesting Procedure-Bone Void Filler	Device: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study 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

Resource links provided by NLM:

Genetics Home Reference related topics: systemic scleroderma

MedlinePlus related topics: Urine and Urination

U.S. FDA Resources

Further study details as provided by Osteotech, Inc:

Primary Outcome Measures:

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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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. ] [ Designated as safety issue: Yes ]

Enrollment:	15
Study Start Date:	January 2009
Study Completion Date:	October 2011
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00837473

Locations

United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021

Sponsors and Collaborators

Osteotech, Inc

Investigators

Principal Investigator:

Oheneba Boachie-Adijei, MD

Hospital for Special Surgery, New York

More Information

No publications provided

Responsible Party:	Osteotech, Inc
ClinicalTrials.gov Identifier:	NCT00837473 History of Changes
Other Study ID Numbers:	Trial #3206
Study First Received:	February 4, 2009
Last Updated:	September 14, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Osteotech, Inc:

Bone Void Filler
Iliac Crest Bone Void Filler
Back Surgery and Autograft Bone
Autograft Bone
Allograft Bone

Additional relevant MeSH terms:

CREST Syndrome
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Raynaud Disease
Peripheral Vascular Diseases
Vascular Diseases

Cardiovascular Diseases
Telangiectasis
Scleroderma, Limited
Scleroderma, Systemic
Connective Tissue Diseases
Skin Diseases
Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 23, 2013