OsseoFit™ Prospective Data Collection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Bone Graft Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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OsseoFit™

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

Group Type EXPERIMENTAL

OsseoFit™ Porous Tissue Matrix™

Intervention Type DEVICE

Bone void filler

Open

Treatment of bone graft site without OsseoFit™ Porous Tissue Matrix™.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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OsseoFit™ Porous Tissue Matrix™

Bone void filler

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No