ultraporous beta-tricalcium phosphate mixed with autologous bone marrow aspirate for patients undergoing surgical curettage for benign bone lesions

ultraporous beta-tricalcium phosphate mixed with calcium sulfate for patients undergoing surgical curettage for benign bone lesions

Bone Lesion

Surgical curettage for benign bone lesion, created defects will be filled with one of two types of graft material Vitoss versus Prodense, there are no other devices or drugs used

Surgical Curettage for benign bone lesion

Vitoss With Bone Marrow Aspirate Versus Prodense

Prospective Randomized Clinical Trial Comparing Ultraporous Beta-TCP With BMA to Combined TCP With Calcium Sulfate in Curetted Benign Bone Lesions

Radiographic interpretation by two independent radiologists was completed to assess the change in percentage of resorption of Vitoss with BMA or Prodense into the native bone at the 6 week, 3, 6, 12, 18 and 24 months timepoints based on review of x-ryas as well as by CT Scan at 12 month post operatively.

Radiographic interpretation by two independent radiologists was completed to assess presence of graft material within the soft tissue at the 6 week, 3, 6, 12, 18 and 24 months timepoints, based on radiograph and CT Scan review

Radiographic interpretation by two independent radiologists was completed to assess change in presense (size/circumference) of radiolucency surrounding grafted defect at the 6 week, 3, 6, 12, 18 and 24 months timepoints, based on radiograph and CT Scan review

Radiographic interpretation by two independent radiologists was completed to assess change in trabeculation (incorporation of graft into new bone) through the defect at the 6 week, 3, 6, 12, 18 and 24 months timepoints based on radiograph and CT Scan review

Radiographic interpretation by two independent radiologists was completed to assess the change in persistence of graft, how much graft material remains in the lesion at the 6 week, 3, 6, 12, 18 and 24 months timepoints based on radiograph and CT Scan review

There is no plan to share IPD at this time

Timothy Damron, M.D.

Professor

State University of New York - Upstate Medical University

Tornier, Inc.

Stryker Nordic

Comparison of ultraporous beta-tricalcium phosphate (Vitoss) with autologous bone marrow aspirate vs ultraporous beta-tricalcium phosphate with calcium sulfate (Prodense)

Intraoperativ application of medical device: CERAMENT™ |BONE VOID FILLER 5cc/10cc/18cc

Bone Cyst

Implantation of bi-phasic ceramic bone substitute to provide bone generation and bone remodeling in patients with benign bone tumors.

CERAMENT™ |BONE VOID FILLER

Complete Twelve Month Bone Remodeling With a Bi-phasic Injectable Bone Substitute in Benign Bone Tumors

A Prospective, Longitudinal Patient Study on CERAMENT™|BONE VOID FILLER in Benign Bone Tumors

Evaluate bone healing and remodeling at 12 month by X-ray and CT-scan using Modified Neer classification of radiological results.

Calculate the pre-operative volume of the cyst, document the volume of product placed into the cyst and the volume of bone formed at 12 months.
In the case of bone cysts assess the ability of CERAMENT™ |BONE VOID FILLER to transform into bone and possibly induce bone formation in regions of the cyst not filled with the product.

Assess the safety of CERAMENT™|BONE VOID FILLER as measured by number of any device complaint/Adverse Event and any subsequent surgical procedure.

calcium sulfate/neoplasms

Vitoss With Bone Marrow Aspirate Versus Prodense

Complete Twelve Month Bone Remodeling With a Bi-phasic Injectable Bone Substitute in Benign Bone Tumors

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