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

 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.
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.