NCT04069923

Brief Summary

This trial studies the side effects of OsteoCrete in filling bone voids in participants with bone voids or defects. OsteoCrete may eliminate the need for further surgery and the removal of healthy bone.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

December 18, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2022

Completed
Last Updated

September 23, 2022

Status Verified

September 1, 2022

Enrollment Period

3.1 years

First QC Date

May 6, 2019

Last Update Submit

September 22, 2022

Conditions

Health Status Unknown

Outcome Measures

Primary Outcomes (1)

  • Participants reaching one year post-op and completing all study visits

    Up to 1 year

Secondary Outcomes (2)

  • Amount of reabsorption and bone ingrowth

    Up to 1 year

  • Incidence of adverse events rates

    Up to 1 year

Study Arms (1)

Treatment (OsteoCrete)

EXPERIMENTAL

Participants receive OsteoCrete intraoperatively to fill voids that occur in bones during surgery or to augment screw fixation.

Other: Magnesium-based Bone Void Filler

Interventions

Magnesium-based Bone Void FillerOTHER

Given intraoperatively

Also known as: Magnesium-based BVF, Osteocrete
Treatment (OsteoCrete)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Interventions

OsteoCrete

Study Officials

  • Francis Hornicek

    UCLA / Jonsson Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2019

First Posted

August 28, 2019

Study Start

December 18, 2018

Primary Completion

January 17, 2022

Study Completion

January 17, 2022

Last Updated

September 23, 2022

Record last verified: 2022-09

Locations

US(1)