Bone Graft, Knee
Conditions
Keywords
Bone graft, Bone void filler, Bone plug, OsseoFit™, knee, bone graft sites in the knee
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.
Interventions
DEVICEOsseoFit™ Porous Tissue Matrix™
Bone void filler
Sponsors
Zimmer Biomet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Site repair grade by MRI analysis | 6 months |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed