- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04069923
OsteoCrete in Filling Bone Voids in Participants With Bone Voids or Defects
Use of Magnesium Oxide Biomaterial as a Bone Void Filler for Bone Voids or Defects Not Intrinsic to the Stability of Bony Structure
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To assess the safety of the device, which for the purpose of this study is defined as the compound injected into bone.
SECONDARY OBJECTIVES:
I. To determine the rate of absorption and bone ingrowth.
OUTLINE:
Participants receive OsteoCrete intraoperatively to fill voids that occur in bones during surgery or to augment screw fixation.
After completion of study treatment, participants are followed for up to 1 year.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- UCLA / Jonsson Comprehensive Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Documentation of a diagnosis as evidenced by one or more clinical features consistent with one or more of the following criteria:
- Bone void created during surgery.
- Lucency noted on x-ray preoperatively.
- Written informed consent (and assent when applicable) obtained from subject or subject?s legal representative and ability for subject to comply with the requirements of the study.
Exclusion Criteria:
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
- Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.
- Creatinine greater than 1.3.
- Presence of active bone infection.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Treatment (OsteoCrete)
Participants receive OsteoCrete intraoperatively to fill voids that occur in bones during surgery or to augment screw fixation.
|
Given intraoperatively
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Participants reaching one year post-op and completing all study visits
Time Frame: Up to 1 year
|
Up to 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Amount of reabsorption and bone ingrowth
Time Frame: Up to 1 year
|
Will be measured in Hounsfield units by X-ray and compute tomography (CT).
|
Up to 1 year
|
Incidence of adverse events rates
Time Frame: Up to 1 year
|
Will be coded by body system and MedDra classification term.
Adverse events will be tabulated by treatment group and will include the number of patients for whom the event occurred, the rate of occurrence, and the severity and relationship to study device.
|
Up to 1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Francis Hornicek, UCLA / Jonsson Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 17-001785 (OTHER: UCLA / Jonsson Comprehensive Cancer Center)
- NCI-2018-01668 (REGISTRY: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Health Status Unknown
-
Roswell Park Cancer InstituteTerminated
-
University of California, San FranciscoNational Cancer Institute (NCI)CompletedHealth Status UnknownUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedHealth Status UnknownUnited States
-
Barbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI)WithdrawnHealth Status Unknown
-
Jerod L Stapleton, PhDNational Cancer Institute (NCI)Active, not recruitingHealth Status UnknownUnited States
-
Ohio State University Comprehensive Cancer CenterWithdrawnHealth Status Unknown
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI)TerminatedHealth Status UnknownUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)Terminated
-
White River Junction Veterans Affairs Medical CenterNational Cancer Institute (NCI)Unknown
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI); National Heart, Lung, and Blood Institute...Active, not recruitingFamily Member | Health Status UnknownUnited States
Clinical Trials on Magnesium-based Bone Void Filler
-
Chiang Mai UniversityCompletedOpen Fracture of FootThailand
-
Poznan University of Medical SciencesCompleted
-
Pioneer Surgical Technology, Inc.TerminatedDegenerative Disc Disease | Spinal Stenosis | SpondylolisthesisUnited States
-
Johannes Gutenberg University MainzCompleted
-
Osteotech, IncCompletedIliac Crest Harvesting Procedure-Bone Void FillerUnited States
-
Synthes GmbHSynthes Asia PacificCompletedTibial FracturesChina, Australia, Netherlands, Norway
-
Lithuanian University of Health SciencesLund University HospitalActive, not recruitingTrochanteric Fracture of FemurLithuania
-
Aksaray UniversityLund University HospitalRecruitingHip Fractures | Trochanteric Fracture of Femur | Bone Density, Low | Osteoporotic Fracture of FemurTurkey
-
Merz North America, Inc.CompletedNasolabial FoldsUnited States
-
Merz North America, Inc.Completed