| 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.
| The primary analysis dataset included all study subjects with available data. | Posted | | Count of Participants | | Participants | | 6 wks, 3 mths, 6 mths 12 mths, and 24 mths | | | | ID | Title | Description |
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| OG000 | 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 |
| | | Title | Denominators | Categories |
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| Reconstitution at 6 weeks | | | Title | Measurements |
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| Absent | | | Mild | |
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| 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. | The primary analysis dataset included all study subjects with available data. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 6 wks, 3 mths, 6 mths, 12 mths, and 24 mths | | | | ID | Title | Description |
|---|
| OG000 | 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 |
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| 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. | The primary analysis dataset included all study subjects with available data. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 6 wks, 3 mths, 6 mths, 12 mths, and 24 mths | | | | ID | Title | Description |
|---|
| OG000 | 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 |
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| 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. | The primary analysis dataset included all study subjects with available data. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 6 wks, 3 mths, 6 mths, 12 mths, and 24 mths | | | | ID | Title | Description |
|---|
| OG000 | 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 |
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| Secondary | Surgical Related Outcome--locations of Iliac Crest Bone Harvest | | | Posted | | Count of Participants | | Participants | | During the time of operation, a range of 2.5-8.5 hrs | | | | ID | Title | Description |
|---|
| OG000 | 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 |
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| Secondary | Surgical outcome-the Amount of Cancellous Bone Harvested | | | Posted | | Mean | Standard Deviation | cc | | During the time of operation, a range of 2.5-8.5 hrs | | | | ID | Title | Description |
|---|
| OG000 | 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 |
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| Secondary | Surgical Outcome--operative Time | | | Posted | | Mean | Standard Deviation | min | | The time of operation, a range of 2.5-8.5 hrs | | | | ID | Title | Description |
|---|
| OG000 | 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 |
| | | Title | Denominators | Categories |
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| Secondary | Surgical Outcome--blood Loss | | | Posted | | Mean | Standard Deviation | ml | | During the time of operation, a range of 2.5-8.5 hrs | | | | ID | Title | Description |
|---|
| OG000 | 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 |
| | | Title | Denominators | Categories |
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| Secondary | Surgical Outcome--length of Hospital Stay | | | Posted | | Mean | Standard Deviation | days | | From admission to discharge, a range of 2 to 20 days | | | | ID | Title | Description |
|---|
| OG000 | 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 |
| | | Title | Denominators | Categories |
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| Secondary | Surgical Outcome- the Amount of Plexur™ P Product Utilized for Filling Void | | | Posted | | Mean | Standard Deviation | cc | | During the time of operation, a range of 2.5-8.5 hrs | | | | ID | Title | Description |
|---|
| OG000 | 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 |
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