Comparing Synthetic Bone Alone Versus Synthetic Bone With Bone Marrow in Bone Lesions

Bone Diseases Clinical Trial

Official title:

A Prospective Randomized Study Comparing Vitoss Alone Versus Vitoss With Bone Marrow Aspirate in Benign Bone Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00147823
• Other study ID #: SUNY UMU IRB # 5130
• Status: Completed
• Phase: N/A
• First received: September 1, 2005
• Last updated: June 4, 2015
• Start date: December 2004
• Est. completion date: December 2011

Study information

• Verified date: December 2013
• Source: State University of New York - Upstate Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a prospective randomized study comparing Vitoss alone versus Vitoss with bone marrow aspirate in benign bone lesions.

Description:

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:

1. presence of graft within the soft tissues,

2. presence of a rim of radiolucency surrounding the grafted defect,

3. size/circumference of the rim of radiolucency,

4. resorption of graft material,

5. trabeculation through the defect and

6. persistence of graft material in the lesion.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with a benign bone lesion requiring surgical curettage

Exclusion Criteria:

• Patients with infection, bone marrow disorders, or other contraindications to use of supplemental bone marrow aspiration as well as those who prefer autologous or allogeneic graft material alone (without synthetic filler) would be excluded.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Diseases

Intervention

Device:
• Vitoss Alone
Synthetic bone graft material
• Vitoss with Bone Marrow Aspirate
Vitoss mixed with Bone Marrow aspirate

Locations

Country	Name	City	State
United States	SUNY Upstate Medical University	Syracuse	New York

Sponsors (2)

Lead Sponsor	Collaborator
State University of New York - Upstate Medical University	Orthovita d/b/a Stryker

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	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.	18 months	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
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.	24 months	No

External Links

•   Paper written in 2002 when study first began
•   second paper written with additional subjects