Compartmental Overpressures Associated to Reamed Intramedullary Nails

This study has been completed.
Sponsor:
Information provided by:
University of Andorra
ClinicalTrials.gov Identifier:
NCT00842101
First received: February 10, 2009
Last updated: February 11, 2009
Last verified: February 2009
  Purpose

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.


Condition Intervention
Tibial Fractures
Device: Quick Pressure Monitor

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by University of Andorra:

Primary Outcome Measures:
  • intracompartmental pressures [ Time Frame: 0-2 hours ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained

Serum


Enrollment: 80
Study Start Date: December 2005
Study Completion Date: September 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
pressure monitor
Tibial Fracture
Device: Quick Pressure Monitor
The monitor measures actively the actual pressure inside the compartment affected.
Other Name: Slit catheter

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with tibial shaft fractures

Criteria

Inclusion Criteria:

  • Tibial shaft fractures treated with intramedullary reamed nails

Exclusion Criteria:

  • Tibial fractures treated with other types of fixation or nails not reamed.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00842101

Locations
Andorra
Orthopaedic and Trauma Unit. Nostra Senyora de Meritxell Hospital
Escaldes, Andorra, AD700
Sponsors and Collaborators
University of Andorra
Investigators
Principal Investigator: JOSE I TORRERO, M.D. Orthopaedic and Trauma Unit. Andorra´s Hospital
  More Information

No publications provided

Responsible Party: JOSE IGNACIO TORRERO, ORTHOPAEDIC AND TRAUMA UNIT. ANDORRA´S HOSPITAL
ClinicalTrials.gov Identifier: NCT00842101     History of Changes
Other Study ID Numbers: UA002
Study First Received: February 10, 2009
Last Updated: February 11, 2009
Health Authority: Andorra: Ministeri de Salut i Benestar

Keywords provided by University of Andorra:
Intramedullary nails
Compartmental syndrome
Fractures

Additional relevant MeSH terms:
Fractures, Bone
Tibial Fractures
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on September 18, 2014