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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00708474
Other study ID # BSM2008001
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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
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