OsseoFit™ Prospective Data Collection

Condition(s) targeted: Bone Graft; Knee

Intervention: OsseoFit™ Porous Tissue Matrix™ (Device)

Phase: N/A

Status: Recruiting

Sponsored by: Biomet Sports Medicine, LLC

Official(s) and/or principal investigator(s):
Richard C Lehman, M.D., Principal Investigator, Affiliation: Unaffiliated

Overall contact:
Biomet Sports Medicine

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.

Official title: OsseoFit™ Porous Tissue Matrix™ Prospective Data Collection

Study design: Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment

Primary outcome: Site repair grade by MRI analysis

Secondary outcome:

Site repair grade by MRI analysis

Pain Score

Function Score

Physical Evaluation

Incidence of adverse events

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

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

Biomet Sports Medicine

Biomet Sports Medicine, Warsaw, Indiana 46582, United States; Recruiting
Morgan Scott, Phone: 574-372-3959, Email: morgan.scott@biomet.com

Starting date: June 2008
Ending date: February 2009
Last updated: January 8, 2009