Vitoss With Bone Marrow Aspirate Versus Prodense

NCT03509480 | Completed

• 1 other identifier: 248474
• Study Type: interventional
• Target: 53
• Locations: 0 countries
• Sites: N/A

Brief Summary

For benign curetted tumor defects, ultraporous beta-tricalcium phosphate (TCP) synthetic graft material (Vitoss; Orthovita, Inc., now Stryker, Inc.) persists for a year or longer in some cases even when BMA is added. What is not known is whether the addition to TCP of calcium sulfate (CS), which by itself has a more rapid resorption profile, will lead to more rapid resorption and incorporation of the composite graft material.

Conditions

Bone Lesion

Outcome Measures

Primary Outcomes (1)

• Change in percentage of resorption of graft materials into the native bone as observed via CT scan

  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.

  minimum of 24 months post operatively

Secondary Outcomes (1)

• Presence of graft material within the soft tissue

  minimum of 24 months post operatively

Other Outcomes (3)

• Change in presense (size/circumference) of radiolucency surrounding grafted defect

  minimum of 24 months post operatively

• Change in trabeculation through the defect

  minimum of 24 months post operatively

• Change in persistence of graft material in the lesion

  minimum of 24 months post operatively

Study Arms (2)

Curettage with Vitoss

ACTIVE COMPARATOR

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

Procedure: Surgical Curettage for benign bone lesion

Curettage with Prodense

ACTIVE COMPARATOR

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

Procedure: Surgical Curettage for benign bone lesion

Interventions

Surgical Curettage for benign bone lesion PROCEDURE

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

Curettage with Prodense; Curettage with Vitoss

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients presenting with cavitary bone lesions requiring surgical curettage (removal of tumor and scraping) will be asked to participate
• Patients must be able to read and understand the written informed consent
• Patients must be willing and able to return to the office for follow up appointments and xrays for at least two years

You may not qualify if:

• Patients with active or chronic infections
• Patients with bone marrow disorders
• Patients with contraindications to use of Vitoss or Prodense as listed on package inserts
• Patients who prefer to use autologous or allogeneic graft material alone (without synthetic filler)

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead
• Stryker Trauma and Extremities: collaborator
• Stryker Nordic: collaborator

Study Officials

• Timothy Damron, MD

  SUNYUMU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: April 26, 2018
• Study Start: January 1, 2009
• Primary Completion: December 31, 2012
• Study Completion: February 28, 2018
• Last Updated: May 1, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share