Open tíbia Fracture With Sub-segmental Bone LossPhase 4NCT03042546
Calcium Sulfate Spacer in Open Tibia Fractures
A Phase 4 study testing Calcium Sulfate, PMMA and No treatment in people with Open tíbia Fracture With Sub-segmental Bone Loss, run by University of Washington at 1 site in United States.
Trial summary
Investigators will compare antibiotic impregnated Calcium sulfate versus PMMA versus nothing in these sub-segmental bone defects. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Open tíbia Fracture With Sub-segmental Bone Loss
- What is being tested?
- Calcium Sulfate, PMMA and No treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 29 May 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Open tibia shaft fracture treated with an IMN
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Harborview Medical Center
Seattle, Washington, 98104
About this study
Official title: Calcium Sulfate Spacer in Open Tibia Fractures With Sub-segmental Bone Loss to Decrease the Need for Secondary Surgery
Investigators will compare antibiotic impregnated Calcium sulfate versus PMMA versus nothing in these sub-segmental bone defects.
- Being tested
- Calcium Sulfate, PMMA, No treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium SulfateDrug
Calcium Sulfate with abx will be used in the defect
PMMADrug
PMMA with abx will be used in the defect
No treatmentOther
The defect will not be treated
| Study group | Role | What they receive |
|---|---|---|
| Calcium Sulphate | Active comparator | Not described Receives: Drug: Calcium Sulfate |
| PMMA | Active comparator | Not described Receives: Drug: PMMA |
| Nothing | Active comparator | Not described Receives: Other: No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With a Nonunion
Radiographic healing at one year with no additional surgery
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start1 Feb 2017
- Primary completion29 May 2018
- Study completion29 May 2018
Why it stopped: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention. Low enrollment and PI leaving institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Open tíbia Fracture With Sub-segmental Bone LossStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claude Sagi, University of Washington
- Investigators
- Claude Sagi, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03042546
- Sponsor's protocol ID
- STUDY00002348
- Status last verified
- Feb 2023
- First submitted
- 27 Jan 2017
- Last updated
- 10 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: there is no plan to share individual data
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcium Sulfate Spacer in Open Tibia Fractures With Sub-segmental Bone Loss to Decrease the Need for Secondary Surgery
- ClinicalTrials.gov ID
- NCT03042546
- Acronym / sponsor ID
- STUDY00002348
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention. Low enrollment and PI leaving institution
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 29 May 2018 (actual)
- Study completion
- 29 May 2018 (actual)
- First posted
- 3 Feb 2017 (estimated)
- Results
- Posted 10 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators will compare antibiotic impregnated Calcium sulfate versus PMMA versus nothing in these sub-segmental bone defects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Calcium Sulphate | Active comparator | Drug: Calcium Sulfate |
| PMMA | Active comparator | Drug: PMMA |
| Nothing | Active comparator | Other: No treatment |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Open tibia shaft fracture treated with an IMN
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Calcium SulfateCalcium Sulfate with abx will be used in the defect | Drug | Calcium Sulphate |
| PMMAPMMA with abx will be used in the defect | Drug | PMMA |
| No treatmentThe defect will not be treated | Other | Nothing |
Primary outcome
Number of Patients With a Nonunion
Time frame: One Year
Radiographic healing at one year with no additional surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. there is no plan to share individual data
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.
Claude Sagi principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Calcium Sulfate, PMMA and No treatment in people with Open tíbia Fracture With Sub-segmental Bone Loss, run by University of Washington 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 10 Feb 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients With a Nonunion (time frame: One 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 10 Feb 2023.