Tibial FracturesNCT00842101
Compartmental Overpressures Associated to Reamed Intramedullary Nails
An observational study of Tibial Fractures, run by University of Andorra at 1 site in Andorra.
Trial summary
The purpose of this study is to determine the effect of reamed intramedullary nails in tibial shaft fractures (as a standard treatment), in raising intracompartmental pressures and therefore determine if they are a risk factor for compartmental syndrome. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tibial Fractures
- What is being tested?
- Quick Pressure Monitor
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteAndorra
- Study dates
- Dec 2005to Sep 2008
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with tibial shaft fractures
Who may be able to join
- Tibial shaft fractures treated with intramedullary reamed nails
Who cannot join
- Tibial fractures treated with other types of fixation or nails not reamed.
Trial locations and contacts
1 site in 1 country.
Andorra1 site
Orthopaedic and Trauma Unit. Nostra Senyora de Meritxell Hospital
Les Escaldes, AD700
About this study
Official title: Effect of Reamed Intramedullary Nails in Tibial Fractures as a Factor of Rising Intracompartmental Pressures: A Clinical Study
The purpose of this study is to determine the effect of reamed intramedullary nails in tibial shaft fractures (as a standard treatment), in raising intracompartmental pressures and therefore determine if they are a risk factor for compartmental syndrome.
Read the detailed description
Compartmental overpressure is a serious problem in relation to the treatment of tibial shaft fractures. When reamed intramedullary nails are used, the risk of suffering a compartmental syndrome must be in mind of surgeons. Diagnostic of compartmental syndrome could be difficult just after the surgical intervention, because the patient is under conditions of regional anesthesia or opioids and analgesics, which could mask the symptomatology. In fact, when there is a great suspicion of this syndrome, we recommend measuring compartmental pressures; therefore, physicians might apply the term delta-P value, which is the result of the mean arterial pressure minus compartmental pressure. If this one is less than 30 mm Hg, a fasciotomy should be performed even when the clinical diagnostic is not clear.
- Conditions
- Tibial Fractures
- Being tested
- Quick Pressure Monitor
- Keywords
- Intramedullary nails, Compartmental syndrome, Fractures
- Medical subject headings
- Tibial Fractures, Compartment Syndromes, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quick Pressure MonitorDevice
Also called Slit catheter
The monitor measures actively the actual pressure inside the compartment affected.
| Study group | Role | What they receive |
|---|---|---|
| pressure monitor | Tibial Fracture Receives: Device: Quick Pressure Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
intracompartmental pressures
Measured: 0-2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2009 (estimated)
- Study startDec 2005
- Primary completionApr 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibial FracturesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Andorra
- Sponsor type
- University, hospital or other
- Investigators
- JOSE I TORRERO, M.D., Principal investigator, Orthopaedic and Trauma Unit. Andorra´s Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00842101
- Sponsor's protocol ID
- UA002
- Status last verified
- Feb 2009
- First submitted
- 10 Feb 2009
- Last updated
- 12 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Reamed Intramedullary Nails in Tibial Fractures as a Factor of Rising Intracompartmental Pressures: A Clinical Study
- ClinicalTrials.gov ID
- NCT00842101
- Acronym / sponsor ID
- UA002
- Conditions
- Tibial Fractures
- Keywords
- Intramedullary nails, Compartmental syndrome, Fractures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of AndorraUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Apr 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 12 Feb 2009 (estimated)
- 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.
The purpose of this study is to determine the effect of reamed intramedullary nails in tibial shaft fractures (as a standard treatment), in raising intracompartmental pressures and therefore determine if they are a risk factor for compartmental syndrome.
Detailed description
Compartmental overpressure is a serious problem in relation to the treatment of tibial shaft fractures. When reamed intramedullary nails are used, the risk of suffering a compartmental syndrome must be in mind of surgeons. Diagnostic of compartmental syndrome could be difficult just after the surgical intervention, because the patient is under conditions of regional anesthesia or opioids and analgesics, which could mask the symptomatology. In fact, when there is a great suspicion of this syndrome, we recommend measuring compartmental pressures; therefore, physicians might apply the term delta-P value, which is the result of the mean arterial pressure minus compartmental pressure. If this one is less than 30 mm Hg, a fasciotomy should be performed even when the clinical diagnostic is not clear.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pressure monitor | – | Device: Quick Pressure MonitorTibial Fracture |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with tibial shaft fractures
Key inclusion criteria (1 listed)
- Tibial shaft fractures treated with intramedullary reamed nails
Key exclusion criteria (1 listed)
- Tibial fractures treated with other types of fixation or nails not reamed.
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 |
|---|---|---|
| Quick Pressure MonitorAlso: Slit catheterThe monitor measures actively the actual pressure inside the compartment affected. | Device | pressure monitor |
Primary outcome
intracompartmental pressures
Time frame: 0-2 hours
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 12 Feb 2009.
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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.
JOSE I TORRERO, M.D. principal investigator
Orthopaedic and Trauma Unit. Andorra´s Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tibial Fractures, run by University of Andorra at 1 site in Andorra.
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: finished, as of the sponsor's last update on 12 Feb 2009. 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 Andorra. 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?
intracompartmental pressures (time frame: 0-2 hours). 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 12 Feb 2009.