Continuous Pressure Monitoring In Lower Leg Fractures
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|ClinicalTrials.gov Identifier: NCT00358514|
Recruitment Status : Terminated (Large sample size and change in Orthopaedic practice to use of CCPM in conjunction with Clinical Monitoring rendered project less timely.)
First Posted : August 1, 2006
Last Update Posted : March 30, 2010
|Condition or disease||Intervention/treatment||Phase|
|Compartment Syndrome||Device: Continuous Compartment Pressure Monitoring||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Continuous Compartment Pressure Monitoring (Ccpm) Following Tibial Fracture: A Prospective Randomized Trial|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||March 2010|
- Device: Continuous Compartment Pressure Monitoring
See Detailed Description.
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00358514
|Canada, British Columbia|
|Vancouver General Hospital|
|Vancouver, British Columbia, Canada|
|Principal Investigator:||P J O'Brien, MD||University of British Columbia|