Health Status UnknownNCT04069923
OsteoCrete in Filling Bone Voids in Participants With Bone Voids or Defects
A study testing Magnesium-based Bone Void Filler in people with Health Status Unknown, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health Status Unknown
- What is being tested?
- Magnesium-based Bone Void Filler
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2018to 17 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
Official title: Use of Magnesium Oxide Biomaterial as a Bone Void Filler for Bone Voids or Defects Not Intrinsic to the Stability of Bony Structure
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the safety of the device, which for the purpose of this study is defined as the compound injected into bone.
SECONDARY OBJECTIVES:
- 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.
- Conditions
- Health Status Unknown
- Being tested
- Magnesium-based Bone Void Filler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium-based Bone Void FillerOther
Also called Magnesium-based BVF, Osteocrete
Given intraoperatively
| Study group | Role | What they receive |
|---|---|---|
| Treatment (OsteoCrete) | Experimental | Participants receive OsteoCrete intraoperatively to fill voids that occur in bones during surgery or to augment screw fixation. Receives: Other: Magnesium-based Bone Void Filler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants reaching one year post-op and completing all study visits
Measured: Up to 1 year
Secondary outcomes (2)
Amount of reabsorption and bone ingrowth
Will be measured in Hounsfield units by X-ray and compute tomography (CT).
Measured: Up to 1 year
Incidence of adverse events rates
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.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start18 Dec 2018
- Primary completion17 Jan 2022
- Study completion17 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Status UnknownStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francis Hornicek, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069923
- Sponsor's protocol ID
- 17-001785
- Other IDs
- NCI-2018-01668, 17-001785
- Status last verified
- Sep 2022
- First submitted
- 6 May 2019
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Magnesium Oxide Biomaterial as a Bone Void Filler for Bone Voids or Defects Not Intrinsic to the Stability of Bony Structure
- ClinicalTrials.gov ID
- NCT04069923
- Acronym / sponsor ID
- 17-001785
- Conditions
- Health Status Unknown
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- 17 Jan 2022 (actual)
- Study completion
- 17 Jan 2022 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- To assess the safety of the device, which for the purpose of this study is defined as the compound injected into bone.
SECONDARY OBJECTIVES:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (OsteoCrete) | Experimental | Other: Magnesium-based Bone Void FillerParticipants receive OsteoCrete intraoperatively to fill voids that occur in bones during surgery or to augment screw fixation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Documentation of a diagnosis as evidenced by one or more clinical features consistent with one or more of the following criteria:
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium-based Bone Void FillerAlso: Magnesium-based BVF, OsteocreteGiven intraoperatively | Other | Treatment (OsteoCrete) |
Primary outcome
Participants reaching one year post-op and completing all study visits
Time frame: Up to 1 year
2 secondary outcomes
Amount of reabsorption and bone ingrowth
Time frame: Up to 1 year
Incidence of adverse events rates
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francis Hornicek principal investigator
UCLA / Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium-based Bone Void Filler in people with Health Status Unknown, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants reaching one year post-op and completing all study visits (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2022.