Continuous Pressure Monitoring In Lower Leg Fractures

Compartment Syndrome Clinical Trial

Official title:

Continuous Compartment Pressure Monitoring (Ccpm) Following Tibial Fracture: A Prospective Randomized Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00358514
• Other study ID #: C06-0063
• Status: Terminated
• Phase: N/A
• First received: July 28, 2006
• Last updated: March 26, 2010
• Start date: September 2008
• Est. completion date: March 2010

Study information

• Verified date: March 2010
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

This study has been designed to allow us to learn more about diagnosing Compartment Syndrome, which is a condition that occurs in approximately 5% of tibial (lower leg) fractures. In Compartment Syndrome, nerves, muscle and blood vessels are affected by swelling within the enclosed spaces (compartments) of the leg. The tissue covering these compartments (called the fascia) is not expandable and is not able to accommodate this swelling, and so the tissues within the compartments become compressed. If the pressure is not relieved it can result in blood flow being blocked to the inside of the compartment (muscle, blood vessels, and nerves) which can lead to permanent injury to the muscle and nerves. Late complications in untreated compartment syndrome include a failure of the injured bone to heal, nerve damage, and contracture (shortening) of muscle, all of which can result in a weak, painful, stiff, and poorly formed limb that is not functioning well, and could result in amputation.

Description:

This study has been designed to prospectively evaluate the clinical results of the use of Continuous Compartment Pressure Monitoring (CCPM) in the treatment of tibial fractures.

Fractures of the tibia cause local haemorrhage, tissue edema and swelling within the indistensible fascial compartments of the leg. In a proportion of patients, pressure within the compartments rises sufficiently high to reduce capillary bed perfusion, resulting in tissue ischemia. This condition is termed compartment syndrome and complicates approximately 5% tibial fractures. The early and late morbidity from untreated compartment syndrome is important. In the early period, severe pain, local muscle necrosis and infection may occur, and systemically, rhabdomyolysis may result in renal failure. Multiple surgical procedures and a prolonged period of hospital treatment may be required to address these complications. Ultimately the affected limb may loose viability and require amputation. Later, non-union of bone, contracture of muscle and permanent nerve palsy may result in a limb that is painful, deformed, weak and stiff with dystrophic and vulnerable skin. This may result in functional impairment, loss of employment, or again amputation.

The treatment of compartment syndrome by emergency fasciotomy of all four leg compartments is universally accepted. However, there is a small but significant level of morbidity associated with this procedure. Local cutaneous nerves may be inadvertently divided, the open wounds may become infected, and the staged closure of such wounds may require several operative procedures under general anaesthetic. The resulting scars are cosmetically prominent and unsightly, and may be hypersensitive or fragile.

The diagnosis of compartment syndrome may be problematic. The clinical features are well described, but in the individual patient may be equivocal, atypical, or masked by analgesia or obtunded consciousness. Although cases of acute compartment syndrome are very rarely missed altogether in contemporary practice, the diagnosis can be delayed for many hours because of uncertainty or lack of awareness of the importance of a subtle and evolving clinical picture. This delay in diagnosis exposes the patient to prolonged compartmental ischemia and an increased risk of complications.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 250
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• 16 years of age and older, presenting for treatment in 24 hours or less

• Diaphyseal or bicondylar plateau fracture of the tibia

Exclusion Criteria:

• Patients under 16 years of age

• Patients who present to VGH more than 24 hours after the injury

• Patients who are not mentally competent to give Informed Consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Compartment Syndrome
• Compartment Syndromes

Intervention

Device:
• Continuous Compartment Pressure Monitoring
See Detailed Description.

Locations

Country	Name	City	State
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outcome measures will be assessed at the time of discharge and at the six and twelve month clinical appointments and will be as follows:		Unspecified	No
Primary	Fasciotomy rate		Unspecified	No
Secondary	Outcome measures will be assessed at the time of discharge and at the six and twelve month clinical appointments and will be as follows:Time from injury to fasciotomy 2) Early local outcomes 3) Late local outcomes		Unspecified	No