OsseoFit™ Prospective Data Collection

Knee Clinical Trial

Official title:

OsseoFit™ Porous Tissue Matrix™ Prospective Data Collection

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00708474
• Other study ID #: BSM2008001
• Status: Withdrawn
• Phase: N/A
• Start date: June 2008
• Est. completion date: February 2009

Study information

• Verified date: January 2019
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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™ device will achieve a better fill grade than those treated with the conventional method.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Graft
• Knee

Intervention

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

Locations

Country	Name	City	State
United States	Biomet Sports Medicine	Warsaw	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Site repair grade by MRI analysis		6 months
Secondary	Site repair grade by MRI analysis		3 months, 1 year
Secondary	Pain Score		3 months, 6 months, 1 year
Secondary	Function Score		3 months, 6 months, 1 year
Secondary	Physical Evaluation		3 months, 6 months, 1 year
Secondary	Incidence of adverse events		Any time