OsseoFit™ Prospective Data Collection

Zimmer Biomet

Status

Withdrawn

Conditions

Knee

Bone Graft

Treatments

Device: OsseoFit™ Porous Tissue Matrix™

Study type

Interventional

Funder types

Industry

Identifiers

NCT00708474

BSM2008001

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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