OsseoFit™ Prospective Data Collection

Study Overview
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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.

Official Title
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OsseoFit™ Porous Tissue Matrix™ Prospective Data Collection

Conditions
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Bone Graft, Knee

Intervention / Treatment
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* Device: OsseoFit™ Porous Tissue Matrix™


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OsseoFit™<br>Treatment of bone graft site with OsseoFit™ Porous Tissue Matrix™. | Device: OsseoFit™ Porous Tissue Matrix™<br>* Bone void filler<br>|
| No Intervention: Open<br>Treatment of bone graft site without OsseoFit™ Porous Tissue Matrix™. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Site repair grade by MRI analysis |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Site repair grade by MRI analysis |  | 3 months, 1 year | 
| Pain Score |  | 3 months, 6 months, 1 year | 
| Function Score |  | 3 months, 6 months, 1 year | 
| Physical Evaluation |  | 3 months, 6 months, 1 year | 
| Incidence of adverse events |  | Any time | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone graft, Bone void filler, Bone plug, OsseoFit™, knee, bone graft sites in the knee