OsseoFit™ Prospective Data Collection

OsseoFit™ Porous Tissue Matrix™ Prospective Data Collection

NCT00708474•Zimmer Biomet

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.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Biomet Sports Medicine

Warsaw, Indiana, United States

Key Dates

Start Date

June 1, 2008

Primary Completion Date

February 1, 2009

Completion Date

February 1, 2009

Last Updated

January 10, 2019

Conditions

Bone GraftKnee

Interventions

OsseoFit™ Porous Tissue Matrix™

DEVICE

A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis

NCT07351968

Moderate Pain in Knee OsteoarthritisSevere Pain in Knee Osteoarthritis

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RECRUITINGNA

General vs Spinal in Total Joint Arthroplasty (TJA)

NCT06747494

Knee OsteoarthritisHip Osteoarthritis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 10, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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OsseoFit™ Prospective Data Collection

Inclusion Criteria

Exclusion Criteria

A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis

General vs Spinal in Total Joint Arthroplasty (TJA)

New Care Pathway Using Automated Dynamic Laximetry

A Randomized Pilot rTMS Trial for Knee Arthritis Pain and Depression

Study to Evaluate the Safety and Effectiveness of the REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure

Knee Injections for Obese Patients With Knee Arthritis