Official Title: “OsseoFit™ Porous Tissue Matrix™ Prospective Data Collection”

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.

Study Type: Interventional

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

Study Primary Completion Date: February 2009

Intervention(s) in this Clinical Trial

• Device: OsseoFit™ Porous Tissue Matrix™
  • Bone void filler

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: OsseoFit™
  • Treatment of bone graft site with OsseoFit™ Porous Tissue Matrix™.
• No Intervention: Open
  • Treatment of bone graft site without OsseoFit™ Porous Tissue Matrix™.

Primary Measures

• Site repair grade by MRI analysis
  • Time Frame: 6 months
    Safety Issue?: No

Secondary Measures

• Site repair grade by MRI analysis
  • Time Frame: 3 months, 1 year
    Safety Issue?: No
• Pain Score
  • Time Frame: 3 months, 6 months, 1 year
    Safety Issue?: No
• Function Score
  • Time Frame: 3 months, 6 months, 1 year
    Safety Issue?: No
• Physical Evaluation
  • Time Frame: 3 months, 6 months, 1 year
    Safety Issue?: No
• Incidence of adverse events
  • Time Frame: Any time
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Biomet Sports Medicine, LLC

Overall Clinical Trial Officials and Contacts

Richard C Lehman, M.D. Principal Investigator Unaffiliated  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00708474

Study ID Number: BSM2008001

ClinicalTrials.gov Identifier: NCT00708474

Health Authority: United States: Institutional Review Board