Trial Outcomes & Findings for Study Performance of The Plexur P™ Bone Void Filler Device in Patients Undergoing Iliac Crest Harvesting Procedures (NCT NCT00837473)

Last Updated: 2018-04-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

15 participants

Primary outcome timeframe

6 wks, 3 mths, 6 mths 12 mths, and 24 mths

Results posted on

2018-04-30

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	15
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Plexur-P Bone Void Filler n=15 Participants 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
Age, Continuous	56.13 years STANDARD_DEVIATION 9.45 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 wks, 3 mths, 6 mths 12 mths, and 24 mths

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

Outcome measures

Outcome measures
Measure	Plexur-P Bone Void Filler n=15 Participants 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 outcome

Timeframe: Baseline, 6 wks, 3 mths, 6 mths, 12 mths, and 24 mths

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

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.

Outcome measures

Outcome measures
Measure	Plexur-P Bone Void Filler n=15 Participants 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
General Health Status SF-36 PCS score at baseline	35.36 units on a scale Standard Deviation 8.67
General Health Status SF-36 PCS score at 6 weeks	29.41 units on a scale Standard Deviation 8.51
General Health Status SF-36 PCS score at 3 months	35.68 units on a scale Standard Deviation 10.36
General Health Status SF-36 PCS score at 6 months	41.68 units on a scale Standard Deviation 10.77
General Health Status SF-36 PCS score at 12 months	41.23 units on a scale Standard Deviation 12.25
General Health Status SF-36 PCS score at 24 months	37.43 units on a scale Standard Deviation 14.90
General Health Status SF-36 MCS score at baseline	43.86 units on a scale Standard Deviation 12.74
General Health Status SF-36 MCS score at 6 weeks	45.91 units on a scale Standard Deviation 14.38
General Health Status SF-36 MCS score at 3 months	54.50 units on a scale Standard Deviation 9.98
General Health Status SF-36 MCS score at 6 months	50.36 units on a scale Standard Deviation 16.24
General Health Status SF-36 MCS score at 12 months	49.69 units on a scale Standard Deviation 12.72
General Health Status SF-36 MCS score at 24 months	44.87 units on a scale Standard Deviation 11.35

SECONDARY outcome

Timeframe: Baseline, 6 wks, 3 mths, 6 mths, 12 mths, and 24 mths

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

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.

Outcome measures

Outcome measures
Measure	Plexur-P Bone Void Filler n=15 Participants 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
Oswestry Disability Index ODI at baseline	54.28 units on a scale Standard Deviation 17.88
Oswestry Disability Index ODI at 6 wks	70.19 units on a scale Standard Deviation 15.95
Oswestry Disability Index ODI at 3 months	56.44 units on a scale Standard Deviation 20.26
Oswestry Disability Index ODI at 6 months	44.86 units on a scale Standard Deviation 16.71
Oswestry Disability Index ODI at 12 months	41.92 units on a scale Standard Deviation 20.03
Oswestry Disability Index ODI at 24 months	50.80 units on a scale Standard Deviation 19.94

SECONDARY outcome

Timeframe: Baseline, 6 wks, 3 mths, 6 mths, 12 mths, and 24 mths

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

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.

Outcome measures

Outcome measures
Measure	Plexur-P Bone Void Filler n=15 Participants 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
Pain Status Assessed by Visual Analog Scale (VAS) Back/neck pain at baseline	3.5 units on a scale Standard Deviation 1.4
Pain Status Assessed by Visual Analog Scale (VAS) Back/neck pain at 6 weeks	2.6 units on a scale Standard Deviation 1.2
Pain Status Assessed by Visual Analog Scale (VAS) Back/neck pain at 3 months	2.3 units on a scale Standard Deviation 1.5
Pain Status Assessed by Visual Analog Scale (VAS) Back/neck pain at 6 months	2.4 units on a scale Standard Deviation 1.1
Pain Status Assessed by Visual Analog Scale (VAS) Back/neck pain at 12 months	2.1 units on a scale Standard Deviation 1.0
Pain Status Assessed by Visual Analog Scale (VAS) Back/neck pain at 24 months	2.8 units on a scale Standard Deviation 1.5
Pain Status Assessed by Visual Analog Scale (VAS) Left leg/arm pain at baseline	2.0 units on a scale Standard Deviation 1.2
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
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
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
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
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
Pain Status Assessed by Visual Analog Scale (VAS) Right leg/arm pain at baseline	2.0 units on a scale Standard Deviation 1.1
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
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
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
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
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 outcome

Timeframe: During the time of operation, a range of 2.5-8.5 hrs

Outcome measures

Outcome measures
Measure	Plexur-P Bone Void Filler n=15 Participants 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
Surgical Related Outcome--locations of Iliac Crest Bone Harvest Left side	8 Participants
Surgical Related Outcome--locations of Iliac Crest Bone Harvest Right side	7 Participants

SECONDARY outcome

Timeframe: During the time of operation, a range of 2.5-8.5 hrs

Outcome measures

Outcome measures
Measure	Plexur-P Bone Void Filler n=15 Participants 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
Surgical outcome-the Amount of Cancellous Bone Harvested	14.6 cc Standard Deviation 5.4

SECONDARY outcome

Timeframe: The time of operation, a range of 2.5-8.5 hrs

Outcome measures

Outcome measures
Measure	Plexur-P Bone Void Filler n=15 Participants 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
Surgical Outcome--operative Time	310.0 min Standard Deviation 97.2

SECONDARY outcome

Timeframe: During the time of operation, a range of 2.5-8.5 hrs

Outcome measures

Outcome measures
Measure	Plexur-P Bone Void Filler n=15 Participants 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
Surgical Outcome--blood Loss	1786.7 ml Standard Deviation 1128.8

SECONDARY outcome

Timeframe: From admission to discharge, a range of 2 to 20 days

Outcome measures

Outcome measures
Measure	Plexur-P Bone Void Filler n=15 Participants 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
Surgical Outcome--length of Hospital Stay	10.7 days Standard Deviation 4.6

SECONDARY outcome

Timeframe: During the time of operation, a range of 2.5-8.5 hrs

Outcome measures

Outcome measures
Measure	Plexur-P Bone Void Filler n=15 Participants 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
Surgical Outcome- the Amount of Plexur™ P Product Utilized for Filling Void	24.7 cc Standard Deviation 5.6

Adverse Events

Plexur-P Bone Void Filler

Serious events: 12 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Plexur-P Bone Void Filler n=15 participants at risk 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
Endocrine disorders Other	6.7% 1/15 • Number of events 1 • Overall study period, up to 24 months All adverse events that observed by the investigator or reported spontaneously by the study participants were recorded on the Clinical Complication/Adverse Event Form by the investigator.
General disorders Other	6.7% 1/15 • Number of events 1 • Overall study period, up to 24 months All adverse events that observed by the investigator or reported spontaneously by the study participants were recorded on the Clinical Complication/Adverse Event Form by the investigator.
Infections and infestations Infection other	6.7% 1/15 • Number of events 1 • Overall study period, up to 24 months All adverse events that observed by the investigator or reported spontaneously by the study participants were recorded on the Clinical Complication/Adverse Event Form by the investigator.
Infections and infestations Other	6.7% 1/15 • Number of events 1 • Overall study period, up to 24 months All adverse events that observed by the investigator or reported spontaneously by the study participants were recorded on the Clinical Complication/Adverse Event Form by the investigator.
Injury, poisoning and procedural complications Other	33.3% 5/15 • Number of events 6 • Overall study period, up to 24 months All adverse events that observed by the investigator or reported spontaneously by the study participants were recorded on the Clinical Complication/Adverse Event Form by the investigator.
Metabolism and nutrition disorders Other	6.7% 1/15 • Number of events 1 • Overall study period, up to 24 months All adverse events that observed by the investigator or reported spontaneously by the study participants were recorded on the Clinical Complication/Adverse Event Form by the investigator.
Musculoskeletal and connective tissue disorders Other	6.7% 1/15 • Number of events 1 • Overall study period, up to 24 months All adverse events that observed by the investigator or reported spontaneously by the study participants were recorded on the Clinical Complication/Adverse Event Form by the investigator.
Nervous system disorders Other	6.7% 1/15 • Number of events 1 • Overall study period, up to 24 months All adverse events that observed by the investigator or reported spontaneously by the study participants were recorded on the Clinical Complication/Adverse Event Form by the investigator.
Product Issues Other	20.0% 3/15 • Number of events 4 • Overall study period, up to 24 months All adverse events that observed by the investigator or reported spontaneously by the study participants were recorded on the Clinical Complication/Adverse Event Form by the investigator.
Respiratory, thoracic and mediastinal disorders Other	20.0% 3/15 • Number of events 5 • Overall study period, up to 24 months All adverse events that observed by the investigator or reported spontaneously by the study participants were recorded on the Clinical Complication/Adverse Event Form by the investigator.
Vascular disorders Other	6.7% 1/15 • Number of events 1 • Overall study period, up to 24 months All adverse events that observed by the investigator or reported spontaneously by the study participants were recorded on the Clinical Complication/Adverse Event Form by the investigator.

Other adverse events

Other adverse events
Measure	Plexur-P Bone Void Filler n=15 participants at risk 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
Cardiac disorders Other	6.7% 1/15 • Number of events 1 • Overall study period, up to 24 months All adverse events that observed by the investigator or reported spontaneously by the study participants were recorded on the Clinical Complication/Adverse Event Form by the investigator.
Gastrointestinal disorders Ileus	20.0% 3/15 • Number of events 3 • Overall study period, up to 24 months All adverse events that observed by the investigator or reported spontaneously by the study participants were recorded on the Clinical Complication/Adverse Event Form by the investigator.
General disorders Edema	13.3% 2/15 • Number of events 2 • Overall study period, up to 24 months All adverse events that observed by the investigator or reported spontaneously by the study participants were recorded on the Clinical Complication/Adverse Event Form by the investigator.
General disorders Other	6.7% 1/15 • Number of events 1 • Overall study period, up to 24 months All adverse events that observed by the investigator or reported spontaneously by the study participants were recorded on the Clinical Complication/Adverse Event Form by the investigator.
Infections and infestations Infection, other	13.3% 2/15 • Number of events 2 • Overall study period, up to 24 months All adverse events that observed by the investigator or reported spontaneously by the study participants were recorded on the Clinical Complication/Adverse Event Form by the investigator.
Infections and infestations Infection, operative site	6.7% 1/15 • Number of events 1 • Overall study period, up to 24 months All adverse events that observed by the investigator or reported spontaneously by the study participants were recorded on the Clinical Complication/Adverse Event Form by the investigator.
Infections and infestations Other	13.3% 2/15 • Number of events 2 • Overall study period, up to 24 months All adverse events that observed by the investigator or reported spontaneously by the study participants were recorded on the Clinical Complication/Adverse Event Form by the investigator.
Injury, poisoning and procedural complications Other	6.7% 1/15 • Number of events 1 • Overall study period, up to 24 months All adverse events that observed by the investigator or reported spontaneously by the study participants were recorded on the Clinical Complication/Adverse Event Form by the investigator.
Investigations Other	20.0% 3/15 • Number of events 3 • Overall study period, up to 24 months All adverse events that observed by the investigator or reported spontaneously by the study participants were recorded on the Clinical Complication/Adverse Event Form by the investigator.
Metabolism and nutrition disorders Other	6.7% 1/15 • Number of events 1 • Overall study period, up to 24 months All adverse events that observed by the investigator or reported spontaneously by the study participants were recorded on the Clinical Complication/Adverse Event Form by the investigator.
Musculoskeletal and connective tissue disorders Other	6.7% 1/15 • Number of events 1 • Overall study period, up to 24 months All adverse events that observed by the investigator or reported spontaneously by the study participants were recorded on the Clinical Complication/Adverse Event Form by the investigator.
Nervous system disorders Other	13.3% 2/15 • Number of events 2 • Overall study period, up to 24 months All adverse events that observed by the investigator or reported spontaneously by the study participants were recorded on the Clinical Complication/Adverse Event Form by the investigator.
Renal and urinary disorders Urine Retention	6.7% 1/15 • Number of events 1 • Overall study period, up to 24 months All adverse events that observed by the investigator or reported spontaneously by the study participants were recorded on the Clinical Complication/Adverse Event Form by the investigator.
Respiratory, thoracic and mediastinal disorders Other	60.0% 9/15 • Number of events 10 • Overall study period, up to 24 months All adverse events that observed by the investigator or reported spontaneously by the study participants were recorded on the Clinical Complication/Adverse Event Form by the investigator.

Additional Information

Clinical Department

Medtronic Spine and Biologics

Phone: 1800-876-3133

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place