Continuous Pressure Monitoring In Lower Leg Fractures
Primary Purpose
Compartment Syndrome
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Continuous Compartment Pressure Monitoring
Sponsored by
About this trial
This is an interventional diagnostic trial for Compartment Syndrome focused on measuring Tibia, fracture, compartment syndrome, fasciotomy
Eligibility Criteria
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
Sites / Locations
- Vancouver General Hospital
Outcomes
Primary Outcome Measures
Outcome measures will be assessed at the time of discharge and at the six and twelve month clinical appointments and will be as follows:
Fasciotomy rate
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00358514
First Posted
July 28, 2006
Last Updated
March 26, 2010
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT00358514
Brief Title
Continuous Pressure Monitoring In Lower Leg Fractures
Official Title
Continuous Compartment Pressure Monitoring (Ccpm) Following Tibial Fracture: A Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Terminated
Why Stopped
Large sample size and change in Orthopaedic practice to use of CCPM in conjunction with Clinical Monitoring rendered project less timely.
Study Start Date
September 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of British Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Compartment Syndrome
Keywords
Tibia, fracture, compartment syndrome, fasciotomy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Continuous Compartment Pressure Monitoring
Intervention Description
See Detailed Description.
Primary Outcome Measure Information:
Title
Outcome measures will be assessed at the time of discharge and at the six and twelve month clinical appointments and will be as follows:
Title
Fasciotomy rate
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
P J O'Brien, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
12. IPD Sharing Statement
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Continuous Pressure Monitoring In Lower Leg Fractures
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