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OsseoFit™ Prospective Data Collection
OsseoFit™ Porous Tissue Matrix™ Prospective Data Collection
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2008
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 25, 2008
CompletedFirst Posted
Study publicly available on registry
July 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedJanuary 10, 2019
January 1, 2019
8 months
June 25, 2008
January 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Site repair grade by MRI analysis
6 months
Secondary Outcomes (5)
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
Study Arms (2)
OsseoFit™
EXPERIMENTALTreatment of bone graft site with OsseoFit™ Porous Tissue Matrix™.
Open
NO INTERVENTIONTreatment of bone graft site without OsseoFit™ Porous Tissue Matrix™.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zimmer Biometlead
Study Sites (1)
Biomet Sports Medicine
Warsaw, Indiana, 46582, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Richard C Lehman, M.D.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2008
First Posted
July 2, 2008
Study Start
June 1, 2008
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
January 10, 2019
Record last verified: 2019-01