OsseoFit™ Prospective Data Collection

January 8, 2019 updated by: Zimmer Biomet

OsseoFit™ Porous Tissue Matrix™ Prospective Data Collection

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Warsaw, Indiana, United States, 46582
        • Biomet Sports Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Site repair grade by MRI analysis
Time Frame: 6 months
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zimmer Biomet

Investigators

  • Principal Investigator: Richard C Lehman, M.D.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Anticipated)

February 1, 2009

Study Completion (Anticipated)

February 1, 2009

Study Registration Dates

First Submitted

June 25, 2008

First Submitted That Met QC Criteria

June 30, 2008

First Posted (Estimate)

July 2, 2008

Study Record Updates

Last Update Posted (Actual)

January 10, 2019

Last Update Submitted That Met QC Criteria

January 8, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BSM2008001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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