OsseoFit™ Prospective Data Collection

Not Applicable

Withdrawn

• Conditions: Knee; Bone Graft
• Interventions: Device: OsseoFit™ Porous Tissue Matrix™

• Registration Number: NCT00708474
• Lead Sponsor: Zimmer Biomet

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-25
• Study First Submitted QC: 2008-06-30
• Study First Posted: 2008-07-02
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-08
• Last Update Posted: 2019-01-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OsseoFit™	OsseoFit™ Porous Tissue Matrix™	Treatment of bone graft site with OsseoFit™ Porous Tissue Matrix™.

Primary Outcome Measures

Name	Time	Method
Site repair grade by MRI analysis	6 months

Secondary Outcome Measures

Name	Time	Method
Pain Score	3 months, 6 months, 1 year
Function Score	3 months, 6 months, 1 year
Incidence of adverse events	Any time
Site repair grade by MRI analysis	3 months, 1 year
Physical Evaluation	3 months, 6 months, 1 year

Trial Locations

Locations (1)

Biomet Sports Medicine; 🇺🇸 Warsaw, Indiana, United States