Iliac Crest Harvesting Procedure-Bone Void Filler
Conditions
Keywords
Bone Void Filler, Iliac Crest Bone Void Filler, Back Surgery and Autograft Bone, Autograft Bone, Allograft Bone
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.
Interventions
DEVICEPlexur-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
Sponsors
Osteotech, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Reconstitution of Bone Growth in the Iliac Crest Bone Void Determined by an Independent Radiologist | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index | Baseline, 6 wks, 3 mths, 6 mths, 12 mths, and 24 mths | 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. |
| Pain Status Assessed by Visual Analog Scale (VAS) | Baseline, 6 wks, 3 mths, 6 mths, 12 mths, and 24 mths | 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. |
| 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 | — |
| General Health Status | Baseline, 6 wks, 3 mths, 6 mths, 12 mths, and 24 mths | 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. |
| 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 | — |
| Surgical Outcome--operative Time | The time of operation, a range of 2.5-8.5 hrs | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Plexur-P Bone Void Filler Single arm. Open Label.
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 | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Plexur-P Bone Void Filler |
|---|---|
| Age, Continuous | 56.13 years STANDARD_DEVIATION 9.45 |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 14 / 15 |
| serious Total, serious adverse events | 12 / 15 |
Outcome results
Primary
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.
Time frame: 6 wks, 3 mths, 6 mths 12 mths, and 24 mths
Population: The primary analysis dataset included all study subjects with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Plexur-P Bone Void Filler | Number of Participants With Reconstitution of Bone Growth in the Iliac Crest Bone Void Determined by an Independent Radiologist | Reconstitution at 6 weeks | Absent | 11 Participants |
| Plexur-P Bone Void Filler | Number of Participants With Reconstitution of Bone Growth in the Iliac Crest Bone Void Determined by an Independent Radiologist | Reconstitution at 6 weeks | Mild | 4 Participants |
| Plexur-P Bone Void Filler | Number of Participants With Reconstitution of Bone Growth in the Iliac Crest Bone Void Determined by an Independent Radiologist | Reconstitution at 6 weeks | Moderate | 0 Participants |
| Plexur-P Bone Void Filler | Number of Participants With Reconstitution of Bone Growth in the Iliac Crest Bone Void Determined by an Independent Radiologist | Reconstitution at 6 weeks | Extensive | 0 Participants |
| Plexur-P Bone Void Filler | Number of Participants With Reconstitution of Bone Growth in the Iliac Crest Bone Void Determined by an Independent Radiologist | Reconstitution at 3 months | Absent | 3 Participants |
| Plexur-P Bone Void Filler | Number of Participants With Reconstitution of Bone Growth in the Iliac Crest Bone Void Determined by an Independent Radiologist | Reconstitution at 3 months | Mild | 1 Participants |
| Plexur-P Bone Void Filler | Number of Participants With Reconstitution of Bone Growth in the Iliac Crest Bone Void Determined by an Independent Radiologist | Reconstitution at 3 months | Moderate | 1 Participants |
| Plexur-P Bone Void Filler | Number of Participants With Reconstitution of Bone Growth in the Iliac Crest Bone Void Determined by an Independent Radiologist | Reconstitution at 3 months | Extensive | 0 Participants |
| Plexur-P Bone Void Filler | Number of Participants With Reconstitution of Bone Growth in the Iliac Crest Bone Void Determined by an Independent Radiologist | Reconstitution at 6 months | Absent | 0 Participants |
| Plexur-P Bone Void Filler | Number of Participants With Reconstitution of Bone Growth in the Iliac Crest Bone Void Determined by an Independent Radiologist | Reconstitution at 6 months | Mild | 10 Participants |
| Plexur-P Bone Void Filler | Number of Participants With Reconstitution of Bone Growth in the Iliac Crest Bone Void Determined by an Independent Radiologist | Reconstitution at 6 months | Moderate | 2 Participants |
| Plexur-P Bone Void Filler | Number of Participants With Reconstitution of Bone Growth in the Iliac Crest Bone Void Determined by an Independent Radiologist | Reconstitution at 6 months | Extensive | 0 Participants |
| Plexur-P Bone Void Filler | Number of Participants With Reconstitution of Bone Growth in the Iliac Crest Bone Void Determined by an Independent Radiologist | Reconstitution at 12 months | Absent | 0 Participants |
| Plexur-P Bone Void Filler | Number of Participants With Reconstitution of Bone Growth in the Iliac Crest Bone Void Determined by an Independent Radiologist | Reconstitution at 12 months | Mild | 6 Participants |
| Plexur-P Bone Void Filler | Number of Participants With Reconstitution of Bone Growth in the Iliac Crest Bone Void Determined by an Independent Radiologist | Reconstitution at 12 months | Moderate | 6 Participants |
| Plexur-P Bone Void Filler | Number of Participants With Reconstitution of Bone Growth in the Iliac Crest Bone Void Determined by an Independent Radiologist | Reconstitution at 12 months | Extensive | 1 Participants |
| Plexur-P Bone Void Filler | Number of Participants With Reconstitution of Bone Growth in the Iliac Crest Bone Void Determined by an Independent Radiologist | Reconstitution at 24 months | Absent | 0 Participants |
| Plexur-P Bone Void Filler | Number of Participants With Reconstitution of Bone Growth in the Iliac Crest Bone Void Determined by an Independent Radiologist | Reconstitution at 24 months | Mild | 1 Participants |
| Plexur-P Bone Void Filler | Number of Participants With Reconstitution of Bone Growth in the Iliac Crest Bone Void Determined by an Independent Radiologist | Reconstitution at 24 months | Moderate | 9 Participants |
| Plexur-P Bone Void Filler | Number of Participants With Reconstitution of Bone Growth in the Iliac Crest Bone Void Determined by an Independent Radiologist | Reconstitution at 24 months | Extensive | 2 Participants |
Secondary
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.
Time frame: Baseline, 6 wks, 3 mths, 6 mths, 12 mths, and 24 mths
Population: The primary analysis dataset included all study subjects with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Plexur-P Bone Void Filler | General Health Status | SF-36 PCS score at baseline | 35.36 units on a scale | Standard Deviation 8.67 |
| Plexur-P Bone Void Filler | General Health Status | SF-36 PCS score at 6 weeks | 29.41 units on a scale | Standard Deviation 8.51 |
| Plexur-P Bone Void Filler | General Health Status | SF-36 PCS score at 3 months | 35.68 units on a scale | Standard Deviation 10.36 |
| Plexur-P Bone Void Filler | General Health Status | SF-36 PCS score at 6 months | 41.68 units on a scale | Standard Deviation 10.77 |
| Plexur-P Bone Void Filler | General Health Status | SF-36 PCS score at 12 months | 41.23 units on a scale | Standard Deviation 12.25 |
| Plexur-P Bone Void Filler | General Health Status | SF-36 PCS score at 24 months | 37.43 units on a scale | Standard Deviation 14.9 |
| Plexur-P Bone Void Filler | General Health Status | SF-36 MCS score at baseline | 43.86 units on a scale | Standard Deviation 12.74 |
| Plexur-P Bone Void Filler | General Health Status | SF-36 MCS score at 6 weeks | 45.91 units on a scale | Standard Deviation 14.38 |
| Plexur-P Bone Void Filler | General Health Status | SF-36 MCS score at 3 months | 54.50 units on a scale | Standard Deviation 9.98 |
| Plexur-P Bone Void Filler | General Health Status | SF-36 MCS score at 6 months | 50.36 units on a scale | Standard Deviation 16.24 |
| Plexur-P Bone Void Filler | General Health Status | SF-36 MCS score at 12 months | 49.69 units on a scale | Standard Deviation 12.72 |
| Plexur-P Bone Void Filler | General Health Status | SF-36 MCS score at 24 months | 44.87 units on a scale | Standard Deviation 11.35 |
Secondary
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.
Time frame: Baseline, 6 wks, 3 mths, 6 mths, 12 mths, and 24 mths
Population: The primary analysis dataset included all study subjects with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Plexur-P Bone Void Filler | Oswestry Disability Index | ODI at baseline | 54.28 units on a scale | Standard Deviation 17.88 |
| Plexur-P Bone Void Filler | Oswestry Disability Index | ODI at 6 wks | 70.19 units on a scale | Standard Deviation 15.95 |
| Plexur-P Bone Void Filler | Oswestry Disability Index | ODI at 3 months | 56.44 units on a scale | Standard Deviation 20.26 |
| Plexur-P Bone Void Filler | Oswestry Disability Index | ODI at 6 months | 44.86 units on a scale | Standard Deviation 16.71 |
| Plexur-P Bone Void Filler | Oswestry Disability Index | ODI at 12 months | 41.92 units on a scale | Standard Deviation 20.03 |
| Plexur-P Bone Void Filler | Oswestry Disability Index | ODI at 24 months | 50.80 units on a scale | Standard Deviation 19.94 |
Secondary
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.
Time frame: Baseline, 6 wks, 3 mths, 6 mths, 12 mths, and 24 mths
Population: The primary analysis dataset included all study subjects with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Plexur-P Bone Void Filler | Pain Status Assessed by Visual Analog Scale (VAS) | Back/neck pain at baseline | 3.5 units on a scale | Standard Deviation 1.4 |
| Plexur-P Bone Void Filler | Pain Status Assessed by Visual Analog Scale (VAS) | Back/neck pain at 6 weeks | 2.6 units on a scale | Standard Deviation 1.2 |
| Plexur-P Bone Void Filler | Pain Status Assessed by Visual Analog Scale (VAS) | Back/neck pain at 3 months | 2.3 units on a scale | Standard Deviation 1.5 |
| Plexur-P Bone Void Filler | Pain Status Assessed by Visual Analog Scale (VAS) | Back/neck pain at 6 months | 2.4 units on a scale | Standard Deviation 1.1 |
| Plexur-P Bone Void Filler | Pain Status Assessed by Visual Analog Scale (VAS) | Back/neck pain at 12 months | 2.1 units on a scale | Standard Deviation 1 |
| Plexur-P Bone Void Filler | Pain Status Assessed by Visual Analog Scale (VAS) | Back/neck pain at 24 months | 2.8 units on a scale | Standard Deviation 1.5 |
| Plexur-P Bone Void Filler | Pain Status Assessed by Visual Analog Scale (VAS) | Left leg/arm pain at baseline | 2.0 units on a scale | Standard Deviation 1.2 |
| Plexur-P Bone Void Filler | Pain Status Assessed by Visual Analog Scale (VAS) | Left leg/arm pain at 6 weeks | 2.1 units on a scale | Standard Deviation 1.2 |
| Plexur-P Bone Void Filler | Pain Status Assessed by Visual Analog Scale (VAS) | Left leg/arm pain at 3 months | 1.7 units on a scale | Standard Deviation 0.6 |
| Plexur-P Bone Void Filler | Pain Status Assessed by Visual Analog Scale (VAS) | Left leg/arm pain at 6 months | 1.7 units on a scale | Standard Deviation 0.8 |
| Plexur-P Bone Void Filler | Pain Status Assessed by Visual Analog Scale (VAS) | Left leg/arm pain at 12 months | 1.9 units on a scale | Standard Deviation 1.4 |
| Plexur-P Bone Void Filler | Pain Status Assessed by Visual Analog Scale (VAS) | Left leg/arm pain at 24 months | 2.0 units on a scale | Standard Deviation 1.4 |
| Plexur-P Bone Void Filler | Pain Status Assessed by Visual Analog Scale (VAS) | Right leg/arm pain at baseline | 2.0 units on a scale | Standard Deviation 1.1 |
| Plexur-P Bone Void Filler | Pain Status Assessed by Visual Analog Scale (VAS) | Right leg/arm pain at 6 weeks | 1.9 units on a scale | Standard Deviation 0.9 |
| Plexur-P Bone Void Filler | Pain Status Assessed by Visual Analog Scale (VAS) | Right leg/arm pain at 3 months | 1.7 units on a scale | Standard Deviation 1.2 |
| Plexur-P Bone Void Filler | Pain Status Assessed by Visual Analog Scale (VAS) | Right leg/arm pain at 6 months | 1.6 units on a scale | Standard Deviation 0.8 |
| Plexur-P Bone Void Filler | Pain Status Assessed by Visual Analog Scale (VAS) | Right leg/arm pain at 12 months | 1.8 units on a scale | Standard Deviation 1.5 |
| Plexur-P Bone Void Filler | Pain Status Assessed by Visual Analog Scale (VAS) | Right leg/arm pain at 24 months | 2.1 units on a scale | Standard Deviation 1.3 |
Secondary
Surgical Outcome--blood Loss
Time frame: During the time of operation, a range of 2.5-8.5 hrs
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Plexur-P Bone Void Filler | Surgical Outcome--blood Loss | 1786.7 ml | Standard Deviation 1128.8 |
Secondary
Surgical Outcome--length of Hospital Stay
Time frame: From admission to discharge, a range of 2 to 20 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Plexur-P Bone Void Filler | Surgical Outcome--length of Hospital Stay | 10.7 days | Standard Deviation 4.6 |
Secondary
Surgical Outcome--operative Time
Time frame: The time of operation, a range of 2.5-8.5 hrs
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Plexur-P Bone Void Filler | Surgical Outcome--operative Time | 310.0 min | Standard Deviation 97.2 |
Secondary
Surgical outcome-the Amount of Cancellous Bone Harvested
Time frame: During the time of operation, a range of 2.5-8.5 hrs
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Plexur-P Bone Void Filler | Surgical outcome-the Amount of Cancellous Bone Harvested | 14.6 cc | Standard Deviation 5.4 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Plexur-P Bone Void Filler | Surgical Outcome- the Amount of Plexur™ P Product Utilized for Filling Void | 24.7 cc | Standard Deviation 5.6 |
Secondary
Surgical Related Outcome--locations of Iliac Crest Bone Harvest
Time frame: During the time of operation, a range of 2.5-8.5 hrs
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Plexur-P Bone Void Filler | Surgical Related Outcome--locations of Iliac Crest Bone Harvest | Left side | 8 Participants |
| Plexur-P Bone Void Filler | Surgical Related Outcome--locations of Iliac Crest Bone Harvest | Right side | 7 Participants |