OsseoFit™ Prospective Data Collection - Full Text View

Sponsor:	Biomet Sports Medicine, LLC
Information provided by:	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00708474

Purpose

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
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

Resource links provided by NLM:

MedlinePlus related topics: Bone Grafts

U.S. FDA Resources

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:

Site repair grade by MRI analysis [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Site repair grade by MRI analysis [ Time Frame: 3 months, 1 year ] [ Designated as safety issue: No ]
Pain Score [ Time Frame: 3 months, 6 months, 1 year ] [ Designated as safety issue: No ]
Function Score [ Time Frame: 3 months, 6 months, 1 year ] [ Designated as safety issue: No ]
Physical Evaluation [ Time Frame: 3 months, 6 months, 1 year ] [ Designated as safety issue: No ]
Incidence of adverse events [ Time Frame: Any time ] [ Designated as safety issue: Yes ]

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
OsseoFit™: Experimental Treatment of bone graft site with OsseoFit™ Porous Tissue Matrix™.	Device: OsseoFit™ Porous Tissue Matrix™ Bone void filler
Open: No Intervention Treatment of bone graft site without OsseoFit™ Porous Tissue Matrix™.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The OsseoFit™ Porous Tissue Matrix™ is intended to be gently packed into the bony voids or gaps of the extremities and pelvis caused by trauma or surgery and are not intrinsic to the stability of the bony structure. These defects may be created from repetitive motion or traumatic injury to the bone or surgically created osseous defects for the harvest of bone. The device is a bone void filler that resorbs and is replaced with bone during the healing process. The device may be combined with sterile fluids such as saline or autogenous blood products such as blood, platelets, or bone marrow aspirate. The addition of these autogenous blood products does not compromise the performance of the device. Hydration with biologically beneficial sterile fluids can potentially have a positive influence on the healing and replacement of the device with bone.

Exclusion Criteria:

Infection at site
Hypercalcemia
Known allergies to bovine collagen
Current osteomyelitis at operative site
Systemic conditions which affect bone and/or wound healing
Known severe allergies manifested by history of anaphylaxis
Desensitization treatment injections to meat products, as injections may contain bovine collagen
Severe degenerative bone disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00708474

Locations

United States, Indiana
Biomet Sports Medicine
Warsaw, Indiana, United States, 46582

Sponsors and Collaborators

Biomet Sports Medicine, LLC

Investigators

Principal Investigator:

Richard C Lehman, M.D.

Unaffiliated

More Information

No publications provided

Responsible Party:	Biomet Sports Medicine ( Robert Cook )
Study ID Numbers:	BSM2008001
Study First Received:	June 25, 2008
Last Updated:	June 18, 2009
ClinicalTrials.gov Identifier:	NCT00708474 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Biomet, Inc.:

Bone graft
Bone void filler
Bone plug

OsseoFit™
knee
bone graft sites in the knee

ClinicalTrials.gov processed this record on February 08, 2010