Text Size

OsseoFit™ Prospective Data Collection

This study has been withdrawn prior to enrollment.
(Planning new study protocol)
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc. ( Biomet Sports Medicine, LLC )
ClinicalTrials.gov Identifier:
NCT00708474
First received: June 25, 2008
Last updated: February 29, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention
Bone Graft
Knee
 Device: OsseoFit™ Porous Tissue Matrix™

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: OsseoFit™ Porous Tissue Matrix™ Prospective Data Collection

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Site repair grade by MRI analysis [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Site repair grade by MRI analysis [ Time Frame: 3 months, 1 year ] [ Designated as safety issue: No ]
  • Pain Score [ Time Frame: 3 months, 6 months, 1 year ] [ Designated as safety issue: No ]
  • Function Score [ Time Frame: 3 months, 6 months, 1 year ] [ Designated as safety issue: No ]
  • Physical Evaluation [ Time Frame: 3 months, 6 months, 1 year ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: Any time ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: June 2008
Estimated Study Completion Date: February 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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™.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00708474

Locations
United States, Indiana
Biomet Sports Medicine
Warsaw, Indiana, United States, 46582
Sponsors and Collaborators
Biomet Sports Medicine, LLC
Investigators
Principal Investigator: Richard C Lehman, M.D.
  More Information

No publications provided

Responsible Party: Biomet, Inc. ( Biomet Sports Medicine, LLC )
ClinicalTrials.gov Identifier: NCT00708474     History of Changes
Other Study ID Numbers: BSM2008001
Study First Received: June 25, 2008
Last Updated: February 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Biomet, Inc.:
Bone graft
Bone void filler
Bone plug
 OsseoFit™
knee
bone graft sites in the knee

ClinicalTrials.gov processed this record on May 23, 2013