OsseoFit™ Prospective Data Collection

Withdrawn before enrolling · Not applicable

Conditions studied: Bone Graft, Knee

In brief

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.

Key facts

Study ID

NCT00708474

Run by

Zimmer Biomet

People needed

0

Starts

2008-06-01

Expected to finish

2009-02-01

Last updated by the study team

2019-01-10

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Biomet Sports Medicine — Warsaw, Indiana, United States

Full record on ClinicalTrials.gov

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