Iliac Crest Harvesting Procedure-Bone Void FillerNCT00837473

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

A study testing Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures in people with Iliac Crest Harvesting Procedure-Bone Void Filler, run by Osteotech, Inc at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Iliac Crest Harvesting Procedure-Bone Void Filler
What is being tested?: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: Jan 2009to Oct 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Hospital for Special Surgery
New York, New York, 10021

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Iliac Crest Harvesting Procedure-Bone Void Filler
Being tested: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures
Keywords: Bone Void Filler, Iliac Crest Bone Void Filler, Back Surgery and Autograft Bone, Autograft Bone, Allograft Bone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting ProceduresDevice
Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures

Study groups in NCT00837473
Study group	Role	What they receive
Plexur-P Bone Void Filler	Other	Single arm. Open Label. Receives: Device: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 wks, 3 mths, 6 mths 12 mths, and 24 mths

Secondary outcomes (9)

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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6 wks, 3 mths, 6 mths, 12 mths, and 24 mths
Surgical Related Outcome--locations of Iliac Crest Bone Harvest
Measured: During the time of operation, a range of 2.5-8.5 hrs
Surgical outcome-the Amount of Cancellous Bone Harvested
Measured: During the time of operation, a range of 2.5-8.5 hrs
Surgical Outcome--operative Time
Measured: The time of operation, a range of 2.5-8.5 hrs
Surgical Outcome--blood Loss
Measured: During the time of operation, a range of 2.5-8.5 hrs
Surgical Outcome--length of Hospital Stay
Measured: From admission to discharge, a range of 2 to 20 days
Surgical Outcome- the Amount of Plexur™ P Product Utilized for Filling Void
Measured: During the time of operation, a range of 2.5-8.5 hrs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2009Oct 2011

First posted5 Feb 2009 (estimated)
Study startJan 2009
Primary completionMar 2011
Study completionOct 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Iliac Crest Harvesting Procedure-Bone Void FillerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00837473
Sponsor's protocol ID: Trial #3206
Status last verified: Sep 2012
First submitted: 4 Feb 2009
Last updated: 30 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Pilot Study on the Performance of The Plexur P™ Bone Void Filler
ClinicalTrials.gov ID: NCT00837473
Acronym / sponsor ID: Trial #3206
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
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Osteotech, IncIndustry (pharma, biotech, devices)
Study start: Jan 2009
Primary completion: Mar 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 5 Feb 2009 (estimated)
Results: Posted 30 Apr 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

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 design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Plexur-P Bone Void Filler	Other	Device: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting ProceduresSingle arm. Open Label.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (15 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting ProceduresPlexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures	Device	Plexur-P Bone Void Filler

Primary outcome

Number of Participants With Reconstitution of Bone Growth in the Iliac Crest Bone Void Determined by an Independent Radiologist
Time frame: 6 wks, 3 mths, 6 mths 12 mths, and 24 mths
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.

9 secondary outcomes

General Health Status
Time frame: Baseline, 6 wks, 3 mths, 6 mths, 12 mths, and 24 mths
Oswestry Disability Index
Time frame: Baseline, 6 wks, 3 mths, 6 mths, 12 mths, and 24 mths
Pain Status Assessed by Visual Analog Scale (VAS)
Time frame: Baseline, 6 wks, 3 mths, 6 mths, 12 mths, and 24 mths
Surgical Related Outcome--locations of Iliac Crest Bone Harvest
Time frame: During the time of operation, a range of 2.5-8.5 hrs
Surgical outcome-the Amount of Cancellous Bone Harvested
Time frame: During the time of operation, a range of 2.5-8.5 hrs
Surgical Outcome--operative Time
Time frame: The time of operation, a range of 2.5-8.5 hrs
Surgical Outcome--blood Loss
Time frame: During the time of operation, a range of 2.5-8.5 hrs
Surgical Outcome--length of Hospital Stay
Time frame: From admission to discharge, a range of 2 to 20 days
Surgical Outcome- the Amount of Plexur™ P Product Utilized for Filling Void
Time frame: During the time of operation, a range of 2.5-8.5 hrs

Results and safety

Results posted to the registry on 30 Apr 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Plexur-P Bone Void Filler	15	12

Primary outcome: Number of Participants With Reconstitution of Bone Growth in the Iliac Crest Bone Void Determined by an Independent Radiologist

Time frame: 6 wks, 3 mths, 6 mths 12 mths, and 24 mths. Count of participants. Unit: Participants

Measure	Plexur-P Bone Void Filler n = 15
Reconstitution at 6 weeks: Absent	11
Reconstitution at 6 weeks: Mild	4
Reconstitution at 6 weeks: Moderate	0
Reconstitution at 6 weeks: Extensive	0
Reconstitution at 3 months: Absent	3
Reconstitution at 3 months: Mild	1
Reconstitution at 3 months: Moderate	1
Reconstitution at 3 months: Extensive	0

Population analysed: The primary analysis dataset included all study subjects with available data.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Overall study period, up to 24 months. Other adverse events reported at 0.0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Plexur-P Bone Void Filler	12 of 15 (80%)	14 of 15 (93.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Oheneba Boachie-Adijei, MD principal investigator

Hospital for Special Surgery, New York

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Reconstitution of Bone Growth in the Iliac Crest Bone Void Determined by an Independent Radiologist (time frame: 6 wks, 3 mths, 6 mths 12 mths, and 24 mths). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00837473.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2018.