OsseoFit™ Prospective Data Collection | NCT00708474

Studies
OsseoFit™ Prospective Data Collection

NCT00708474

Sponsor

Zimmer Biomet

Status

Withdrawn

Last Update Posted

Jan 10, 2019Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Bone Graft
Knee

Interventions

OsseoFit™ Porous Tissue Matrix™

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Planning new study protocol

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Feb 2009Estimated

Completion Date

Feb 2009Estimated

First Submitted Date

Jun 25, 2008

First Submission Date that Met QC Criteria

Jun 30, 2008

First Posted Date

Jul 2, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 8, 2019

Last Update Posted Date

Jan 10, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OsseoFit™	Experimental	Treatment of bone graft site with OsseoFit™ Porous Tissue Matrix™.	Device: OsseoFit™ Porous Tissue Matrix™
Open	No Intervention	Treatment of bone graft site without OsseoFit™ Porous Tissue Matrix™.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OsseoFit™ Porous Tissue Matrix™	Device	Bone void filler	OsseoFit™

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

Measure	Description	Time Frame
Site repair grade by MRI analysis		3 months, 1 year
Pain Score		3 months, 6 months, 1 year
Function Score

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided