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Sponsored by: |
Biomet Sports Medicine, LLC |
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Information provided by: | Biomet, Inc. |
ClinicalTrials.gov Identifier: | NCT00708474 |
This study compares the fill of bone graft sites in the knee. It is hypothesized that harvest sites, voids, and defects caused by trauma that are treated with the OsseoFit™ Porous Tissue Matrix™ device will achieve a better fill grade than those treated with the conventional method.
Condition | Intervention |
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Bone Graft Knee |
Device: OsseoFit™ Porous Tissue Matrix™ |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment |
Official Title: | OsseoFit™ Porous Tissue Matrix™ Prospective Data Collection |
Estimated Enrollment: | 36 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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OsseoFit™: Experimental
Treatment of bone graft site with OsseoFit™ Porous Tissue Matrix™.
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Device: OsseoFit™ Porous Tissue Matrix™
Bone void filler
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Open: No Intervention
Treatment of bone graft site without OsseoFit™ Porous Tissue Matrix™.
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Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Biomet Sports Medicine |
United States, Indiana | |
Biomet Sports Medicine | Recruiting |
Warsaw, Indiana, United States, 46582 | |
Contact: Morgan Scott 574-372-3959 morgan.scott@biomet.com |
Principal Investigator: | Richard C Lehman, M.D. | Unaffiliated |
Responsible Party: | Biomet Sports Medicine ( Robert Cook ) |
Study ID Numbers: | BSM2008001 |
Study First Received: | June 25, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00708474 |
Health Authority: | United States: Institutional Review Board |
Bone graft Bone void filler Bone plug |
OsseoFit™ knee bone graft sites in the knee |