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| Name | Class |
|---|---|
| Orthovita d/b/a Stryker | INDUSTRY |
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This is a prospective randomized study comparing Vitoss alone versus Vitoss with bone marrow aspirate in benign bone lesions.
Bone graft obtained from a patient's own bone (autogenous), usually around the pelvis, is currently considered the gold standard for bone grafting material. It provides a structural scaffold on which the patient's own bone may grow into (osteoconduction), growth factors that can stimulate healing (osteoinduction), and primitive cells (progenitors) that can stimulate bone formation directly (osteogenesis). It readily regains a blood supply from the surrounding tissues (revascularization) and is incorporated into the recipient site. However, there are significant disadvantages in the use of the patient's own bone graft including complications where the bone is taken from (donor site morbidity), limited availability and expense. For defects created by scraping (curettage) of non-cancerous (benign) bone lesions, a structural scaffold (osteoconduction) is generally considered the minimal necessary role that the graft material must serve to allow healing of the defect. Hence, human donor bone procured at the time of death (allografts) and synthetic bone fillers have been used as an alternative to the patient's own bone (autogenous bone graft).
The question that remains is whether additional growth factors that can stimulate bone formation (osteoinductive property) and/or cells that form bone directly (osteogenic property) facilitate healing of these defects when added to a material other than the patient's own bone graft source. In our experience with the use of the synthetic bone graft substitute ultraporous beta-tricalcium phosphate (TCP) (Vitoss, Orthovita, Inc.) over the last 3 years, the graft material, when combined with local blood alone, has performed well clinically but has persisted for a year or longer radiographically in some cases. Prolonged persistence of the graft material may serve as a potential stress riser, although we did not observe any untoward late effects in our published work. Several authors have studied the effects of composite grafts formed from a combination of bone graft substitutes and the patient's own bone marrow in animal models with promising results. There are no studies in the current literature evaluating the effects of healing in composite ultraporous beta-tricalcium phosphate and bone marrow aspirate (BMA) in defects after scraping of benign tumors (cavitary defects) in humans. The purpose of this study is to prospectively examine healing of cavitary defects treated with TCP alone versus those treated with TCP combined with BMA. Our hypothesis is that both graft resorption and trabeculation (radiographic measures of incorporation of the synthetic material by the native bone) will be more advanced at each time point in those patients that receive BMA plus TCP compared to those that receive TCP alone. Patients with any type of benign bone lesion indicated for surgical curettage would be offered inclusion in the study and followed for a minimum of 2 years post-operatively. Bone marrow aspiration would be obtained by a needle inserted through the skin (percutaneous aspiration) from the large bone of the pelvis (iliac crest) using a standard bone marrow aspiration needle. Patients with infection, bone marrow disorders, or other conditions that preclude use of supplementary the patient's bone marrow as well as those who prefer to use their own bone graft material (autograft) or donated human bone graft (allograft) alone would be excluded. Each patient will undergo radiographic evaluation of the lesion at 6 weeks, 3 months, 6 months, 1 year, 18 months and 2 years post operatively. At one time point (1 year) a computerized tomogram (CT) of the grafted region will be obtained for each patient. Two qualified, blinded, independent reviewers will evaluate the radiographs and CT scans for six criteria:
Kappa statistics have shown good agreement for these parameters in our retrospective preliminary analysis of results for the TCP use without bone marrow over the first 2 years of its use by the PI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitoss with bone marrow aspirate | Experimental | Addition of Vitoss to the bone marrow aspirate |
|
| Vitoss Alone | Active Comparator | vitoss alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitoss Alone | Device | Synthetic bone graft material |
| |
| Vitoss with Bone Marrow Aspirate |
| Measure | Description | Time Frame |
|---|---|---|
| Resorption of Graft Material (GR) Compared at 24 Months | Percentage of graft material that is resorbed (disappears) from area of incorporation, at 24 months .Participants were seen 24 month follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken. | 24 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Bone Trabeculation Through the Defect (BT) Compared at 24 Months | Bone trabeculation through the bone lesion at 24 months as determined with radiographs. There were several participants with incomplete follow up or incomplete radiographs. . | 24 months |
| Resorption of Graft Material (GR) Compared at 18 Months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy A. Damron, M.D. | State University of New York - Upstate Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
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| Label | URL |
|---|---|
| Paper written in 2002 when study first began | View source |
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Subjects seen by Dr. Damron in his clinical office were asked to participate, if they met the inclusion/exclusion criteria. Dates of recruitment February 2005, through August 2007
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitoss Alone | No bone marrow aspirate used |
| FG001 | Vitoss With Bone Marrow Aspirate | Addition of Vitoss to the bone marrow aspirate Vitoss : Synthetic bone graft material |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Subjects were randomized
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| ID | Title | Description |
|---|---|---|
| BG000 | Vitoss Used With Bone Marrow Aspirate | Vitoss: Synthetic bone graft material mixed with Bone Marrow aspirate |
| BG001 | Vitoss Only | Vitoss: Synthetic bone graft material alone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Resorption of Graft Material (GR) Compared at 24 Months | Percentage of graft material that is resorbed (disappears) from area of incorporation, at 24 months .Participants were seen 24 month follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken. | Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this timepoint. | Posted | Mean | Full Range | percentage of resorption | 24 months |
|
6 week, 3, 6, 12, 18 and 24 months
Subjects were asked at their office visits if they had any new complications, any new diagnosis/treatments, also if records were received from another physician, this information was collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vitoss Without Bone Marrow Aspirate | subjects who received Vitoss without bone marrow aspirate |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
Limitation due to incomplete follow up by subjects or unavailability of radiographs. Also difficulties in assessing the outcomes of resorption if lesions were small or there was artifact from hardware in the area.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Timothy A. Damron, MD | SUNY Upstate Medical University | 315-464-8604 | damront@upstate.edu |
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| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
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| Device |
Vitoss mixed with Bone Marrow aspirate |
|
Percentage of graft material that is resorbed (disappears) from area of incorporation at 18 months. Participants were seen 18 month follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken. |
| 18 months |
| Bone Trabeculation Through the Defect (BT) Compared at 18 Months | Bone trabeculation through the bone lesion at 18 months with reviewed with radiographs. There were several participants with incomplete follow up or incomplete radiographs. | 18 months |
| Resorption of Graft Material (GR) Compared at 12 Months | Percentage of graft material that is resorbed (disappears) from area of incorporation at 12months. Participants were seen 12 month follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken. | 12 months |
| Bone Trabeculation Through the Defect (BT) Compared at 12 Months | Bone trabeculation through the bone lesion at 12 months was reviewed with radiographs. There were several participants with incomplete follow up or incomplete radiographs. | 12 months |
| Resorption of Graft Material (GR) Compared at 6 Months | Percentage of graft material that is resorbed (disappears) from area of incorporation at 6 months. Participants were seen 6 month follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken. | 6 months |
| Bone Trabeculation Through the Defect (BT) Compared at 6 Months | Bone trabeculation through the bone lesion at 6 months was reviewed with radiographs. There were several participants with incomplete follow up or incomplete radiographs. | 6 months |
| Resorption of Graft Material (GR) Compared at 3 Months | Percentage of graft material that is resorbed (disappears) from area of incorporation at 3 months. Participants were seen 3 month follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken. | 3 months |
| Bone Trabeculation Through the Defect (BT) Compared at 3 Months | Bone trabeculation through the bone lesion compared at 3 months were reviewed with radiographs. There were several participants with incomplete follow up or incomplete radiographs. | 3 months |
| Resorption of Graft Material (GR) Compared at 6 Weeks | Percentage of graft material that is resorbed (disappears) from area of incorporation at 6 weeks. Participants were seen 6 week follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken. | 6 weeks |
| Bone Trabeculation Through the Defect (BT) Compared at 6 Weeks | Bone trabeculation through the bone lesion compared at 6 weeks were reviewed with radiographs. There were several participants with incomplete follow up or incomplete radiographs. | 6 weeks |
| Withdrawal by Subject |
|
| Did not receive vitoss due to infection |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Vitoss alone, not bone marrow aspirate used
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|
|
| Other Pre-specified | Bone Trabeculation Through the Defect (BT) Compared at 24 Months | Bone trabeculation through the bone lesion at 24 months as determined with radiographs. There were several participants with incomplete follow up or incomplete radiographs. . | Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs at this time point. | Posted | Mean | Full Range | percentage of trabeculation | 24 months |
|
|
|
|
| Other Pre-specified | Resorption of Graft Material (GR) Compared at 18 Months | Percentage of graft material that is resorbed (disappears) from area of incorporation at 18 months. Participants were seen 18 month follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken. | Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point. | Posted | Mean | Full Range | percentage of resorption | 18 months |
|
|
|
| Other Pre-specified | Bone Trabeculation Through the Defect (BT) Compared at 18 Months | Bone trabeculation through the bone lesion at 18 months with reviewed with radiographs. There were several participants with incomplete follow up or incomplete radiographs. | Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point. | Posted | Mean | Full Range | percentage of trabeculation | 18 months |
|
|
|
| Other Pre-specified | Resorption of Graft Material (GR) Compared at 12 Months | Percentage of graft material that is resorbed (disappears) from area of incorporation at 12months. Participants were seen 12 month follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken. | Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point. | Posted | Mean | Full Range | percentage of resorption | 12 months |
|
|
|
| Other Pre-specified | Bone Trabeculation Through the Defect (BT) Compared at 12 Months | Bone trabeculation through the bone lesion at 12 months was reviewed with radiographs. There were several participants with incomplete follow up or incomplete radiographs. | Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point. | Posted | Mean | Full Range | percentage of trabeculation | 12 months |
|
|
|
| Other Pre-specified | Resorption of Graft Material (GR) Compared at 6 Months | Percentage of graft material that is resorbed (disappears) from area of incorporation at 6 months. Participants were seen 6 month follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken. | Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point. | Posted | Mean | Full Range | percentage of resorption | 6 months |
|
|
|
| Other Pre-specified | Bone Trabeculation Through the Defect (BT) Compared at 6 Months | Bone trabeculation through the bone lesion at 6 months was reviewed with radiographs. There were several participants with incomplete follow up or incomplete radiographs. | Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point. | Posted | Mean | Full Range | percentage of trabeculation | 6 months |
|
|
|
| Other Pre-specified | Resorption of Graft Material (GR) Compared at 3 Months | Percentage of graft material that is resorbed (disappears) from area of incorporation at 3 months. Participants were seen 3 month follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken. | Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point. | Posted | Mean | Full Range | percentage of resorption | 3 months |
|
|
|
| Other Pre-specified | Bone Trabeculation Through the Defect (BT) Compared at 3 Months | Bone trabeculation through the bone lesion compared at 3 months were reviewed with radiographs. There were several participants with incomplete follow up or incomplete radiographs. | Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point. | Posted | Mean | Full Range | percentage of trabeculation | 3 months |
|
|
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| Other Pre-specified | Resorption of Graft Material (GR) Compared at 6 Weeks | Percentage of graft material that is resorbed (disappears) from area of incorporation at 6 weeks. Participants were seen 6 week follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken. | Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point. | Posted | Mean | Full Range | percentage of resorption | 6 weeks |
|
|
|
| Other Pre-specified | Bone Trabeculation Through the Defect (BT) Compared at 6 Weeks | Bone trabeculation through the bone lesion compared at 6 weeks were reviewed with radiographs. There were several participants with incomplete follow up or incomplete radiographs. | Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point. | Posted | Mean | Full Range | percentage of trabeculation | 6 weeks |
|
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|
| 0 |
| 32 |
| 11 |
| 32 |
| EG001 | Vitoss With Bone Marrow Aspirate | subjects who received Vitoss with bone marrow aspirate | 0 | 31 | 14 | 31 |
| Knee pain-persistent | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| recurrence of cyst | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| fracture of wrist | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| low back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| bilateral leg weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| drainage at incision | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| femur pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| hip pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| shoulder pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| cervical neuropathy | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| rash at incision | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| fracture of shoulder through lesion | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| fracture of femur through lesion | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| hematoma | Blood and lymphatic system disorders | Systematic Assessment |
|
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