N/A
N=63
Comparing Synthetic Bone Alone Versus Synthetic Bone With Bone Marrow in Bone Lesions
Bone Diseases
Bottom Line
View on ClinicalTrials.gov: NCT00147823 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Resorption of Graft Material (GR) Compared at 24 Months — 51; 47 percentage of resorption — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Vitoss Alone (Device); Vitoss with Bone Marrow Aspirate (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- State University of New York - Upstate Medical University
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Resorption of Graft Material (GR) Compared at 24 Months |
51; 47 | <0.01 sig |
Summary
This is a prospective randomized study comparing Vitoss alone versus Vitoss with bone marrow aspirate in benign bone lesions.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00147823). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.