Trials / Completed
CompletedNCT00842101
Compartmental Overpressures Associated to Reamed Intramedullary Nails
Effect of Reamed Intramedullary Nails in Tibial Fractures as a Factor of Rising Intracompartmental Pressures: A Clinical Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 80 (actual)
- Sponsor
- University of Andorra · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Quick Pressure Monitor | The monitor measures actively the actual pressure inside the compartment affected. |
Timeline
- Start date
- 2005-12-01
- Primary completion
- 2008-04-01
- Completion
- 2008-09-01
- First posted
- 2009-02-12
- Last updated
- 2009-02-12
Locations
1 site across 1 country: Andorra
Source: ClinicalTrials.gov record NCT00842101. Inclusion in this directory is not an endorsement.