Compartment SyndromeNCT00358514
Continuous Pressure Monitoring In Lower Leg Fractures
A study testing Continuous Compartment Pressure Monitoring in people with Compartment Syndrome, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Compartment Syndrome
- What is being tested?
- Continuous Compartment Pressure Monitoring
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2008to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 16 years of age and older, presenting for treatment in 24 hours or less
- Diaphyseal or bicondylar plateau fracture of the tibia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Compartment Pressure Monitoring (Ccpm) Following Tibial Fracture: A Prospective Randomized Trial
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.
Read the 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.
- Conditions
- Compartment Syndrome
- Being tested
- Continuous Compartment Pressure Monitoring
- Keywords
- Tibia, fracture, compartment syndrome, fasciotomy
- Medical subject headings
- Compartment Syndromes, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Compartment Pressure MonitoringDevice
See Detailed Description.
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (1)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2006 (estimated)
- Study startSep 2008
- Primary completionMar 2010
- Study completionMar 2010
Why it stopped: Large sample size and change in Orthopaedic practice to use of CCPM in conjunction with Clinical Monitoring rendered project less timely.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compartment SyndromeStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Investigators
- P J O'Brien, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00358514
- Sponsor's protocol ID
- C06-0063
- Status last verified
- Mar 2010
- First submitted
- 28 Jul 2006
- Last updated
- 30 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Compartment Pressure Monitoring (Ccpm) Following Tibial Fracture: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT00358514
- Acronym / sponsor ID
- C06-0063
- Conditions
- Compartment Syndrome
- Keywords
- Tibia, fracture, compartment syndrome, fasciotomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Large sample size and change in Orthopaedic practice to use of CCPM in conjunction with Clinical Monitoring rendered project less timely.
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 1 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 16 years of age and older, presenting for treatment in 24 hours or less
- Diaphyseal or bicondylar plateau fracture of the tibia
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Compartment Pressure MonitoringSee Detailed Description. | Device | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: Large sample size and change in Orthopaedic practice to use of CCPM in conjunction with Clinical Monitoring rendered project less timely.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2010.
Related trials for Compartment Syndrome
Enrolling by invitationObservational study
WSACS 2026 Delphi Consensus on the Practical Management of Intra-abdominal Hypertension and Abdominal Compartment Syndrome
Intra-Abdominal Hypertension, Abdominal Compartment Syndrome
Not yet recruitingObservational study
From Blast Injury to Multicompartment Dysfunction:
Compartment Syndrome, Compartment Syndrome Nontraumatic Lower Extremity
Recruiting
Physiotherapy or Fasciotomy as Treatment for Chronic Exertional Compartment Syndrome in the Lower Leg?
Compartment Syndrome Nontraumatic Lower Leg
Not yet recruitingObservational study
Intra-Abdominal Pressure, Respiratory Mechanics, and Ventilator Liberation After Emergency Major Laparotomy
Intra-Abdominal Hypertension, Respiratory Mechanics
RecruitingPhase 4
Preoperative BOTOX® Injection for Large Ventral Hernia Repair
Hernia Abdominal Wall, Botox Injection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
P J O'Brien, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Compartment Pressure Monitoring in people with Compartment Syndrome, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Large sample size and change in Orthopaedic practice to use of CCPM in conjunction with Clinical Monitoring rendered project less timely.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcome measures will be assessed at the time of discharge and at the six and twelve month clinical appointments and will be as follows:. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2010.