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

NCT00147823 | Completed Results DMC

• 1 other identifier: SUNY UMU IRB # 5130
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bone Diseases

Keywords

Bone formation; Bone lesions; Benign bone lesion

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (11)

• Bone Trabeculation Through the Defect (BT) Compared at 24 Months

  24 months

• Resorption of Graft Material (GR) Compared at 18 Months

  18 months

• Bone Trabeculation Through the Defect (BT) Compared at 18 Months

  18 months

Study Arms (2)

Vitoss with bone marrow aspirate

EXPERIMENTAL

Addition of Vitoss to the bone marrow aspirate

Device: Vitoss with Bone Marrow Aspirate

Vitoss Alone

ACTIVE COMPARATOR

vitoss alone

Device: Vitoss Alone

Interventions

Vitoss Alone DEVICE

Synthetic bone graft material

Vitoss Alone

Vitoss with Bone Marrow Aspirate DEVICE

Vitoss mixed with Bone Marrow aspirate

Vitoss with bone marrow aspirate

Eligibility Criteria

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

You may qualify if:

• Patients with a benign bone lesion requiring surgical curettage

You may not qualify if:

• 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.

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead
• Orthovita d/b/a Stryker: collaborator

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Related Links

• Paper written in 2002 when study first began

MeSH Terms

Conditions

Bone Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Timothy A. Damron, MD
• Organization: SUNY Upstate Medical University

damront@upstate.edu

315-464-8604

Study Officials

• Timothy A. Damron, M.D.

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: Associate Professor

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 7, 2005
• Study Start: December 1, 2004
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: June 8, 2015
• Results First Posted: June 8, 2015

Record last verified: 2013-12

Locations

US (1)