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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Pilot Study on the Performance of The Plexur P™ Bone Void Filler

Conditions
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Iliac Crest Harvesting Procedure-Bone Void Filler

Intervention / Treatment
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* Device: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Plexur-P Bone Void Filler<br>Single arm. Open Label. | Device: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures<br>* Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Reconstitution of Bone Growth in the Iliac Crest Bone Void Determined by an Independent Radiologist | Reconstitution of bone growth was determined by an independent radiologist based on bony ingrowth and absence of a gap according to the following criteria: Absent: limited or no bone mineralization visualized at the defect site; extensive areas of radiolucency. Mild: identifiable bone mineralization and coalescence of the bone graft mass of < 50% of the defect site. Moderate: identifiable bone mineralization and coalescence of the bone graft mass over > 50% of the defect site; some remaining unmineralized areas of radiolucency; limited evidence of partial bone remodeling and trabeculation. Extensive: > 75% of bone mineralization over the defect site showing a contiguous and completely coalesced bone graft mass with confluent trabecular pattern. | 6 wks, 3 mths, 6 mths 12 mths, and 24 mths | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General Health Status | The general health status was assessed by Medical Outcomes Study 36-Item Short Form Health Survey (SF-36v2). The SF-36v2 questionnaire contains 36 questions pertaining to eight subscales of health status. These eight subscales can be summarized as relating to either physical health or mental health. The physical component summary (PCS) is based primarily on the physical functioning, role-physical, bodily pain, and general health scales of the SF-36v2 survey. The mental component summary (MCS) encompasses vitality, social functioning, role-emotional, and mental health scales. The score for PCS and MCS is between 0 and 100, with higher scores denoting better quality of life. | Baseline, 6 wks, 3 mths, 6 mths, 12 mths, and 24 mths | 
| Oswestry Disability Index | The Oswestry Disability Index (ODI) is an internationally validated questionnaire consisting of ten sets of statements which focus on pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and ability to travel. ODI scores are in a range of 0 to 100, with a lower score indicating less pain and disability and higher scores indicating more pain and disability. | Baseline, 6 wks, 3 mths, 6 mths, 12 mths, and 24 mths | 
| Pain Status Assessed by Visual Analog Scale (VAS) | The visual analog scale (VAS) was used for assessing pain status in the body locations of back/neck, left leg/arm, and right arm/leg. Subjects were asked to rate their perception of pain in VAS, generated by the Osteotech Clinical Department. The scale from 1 to 5 represented the pain levels at none, mild, average, severe, and extreme. | Baseline, 6 wks, 3 mths, 6 mths, 12 mths, and 24 mths | 
| Surgical Related Outcome--locations of Iliac Crest Bone Harvest |  | During the time of operation, a range of 2.5-8.5 hrs | 
| Surgical outcome-the Amount of Cancellous Bone Harvested |  | During the time of operation, a range of 2.5-8.5 hrs | 
| Surgical Outcome--operative Time |  | The time of operation, a range of 2.5-8.5 hrs | 
| Surgical Outcome--blood Loss |  | During the time of operation, a range of 2.5-8.5 hrs | 
| Surgical Outcome--length of Hospital Stay |  | From admission to discharge, a range of 2 to 20 days | 
| Surgical Outcome- the Amount of Plexur™ P Product Utilized for Filling Void |  | During the time of operation, a range of 2.5-8.5 hrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone Void Filler, Iliac Crest Bone Void Filler, Back Surgery and Autograft Bone, Autograft Bone, Allograft Bone