Status:
WITHDRAWN
OsseoFit™ Prospective Data Collection
Lead Sponsor:
Zimmer Biomet
Conditions:
Bone Graft
Knee
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
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™ devic...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00708474
Start Date
June 1 2008
End Date
February 1 2009
Last Update
January 10 2019
Active Locations (1)
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1
Biomet Sports Medicine
Warsaw, Indiana, United States, 46582