Compartmental Overpressures Associated to Reamed Intramedullary Nails
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Effect of Reamed Intramedullary Nails in Tibial Fractures as a Factor of Rising Intracompartmental Pressures: A Clinical Study|
- intracompartmental pressures [ Time Frame: 0-2 hours ] [ Designated as safety issue: Yes ]
Biospecimen Retention: None Retained
|Study Start Date:||December 2005|
|Study Completion Date:||September 2008|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
Device: Quick Pressure Monitor
The monitor measures actively the actual pressure inside the compartment affected.
Other Name: Slit catheter
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00842101
|Orthopaedic and Trauma Unit. Nostra Senyora de Meritxell Hospital|
|Escaldes, Andorra, AD700|
|Principal Investigator:||JOSE I TORRERO, M.D.||Orthopaedic and Trauma Unit. Andorra´s Hospital|