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Compartment syndrome is a very serious musculoskeletal disorder, which can lead to potentially devastating consequences, such as limb amputation and life-threatening conditions. It is a well described medical condition considered to be an orthopaedic emergency affecting all ages.
Even though compartment syndrome is a well described medical condition, the appropriate treatment (i.e., fasciotomy to release tissue pressure) is invasive and involves its own risks. Furthermore, and of most critical importance is the timing for the intervention of a fasciotomy. The concerned limb may already have had severe, sometimes even irreversible, tissue damage due to high intra-compartmental pressure within 6 to 10 hours.
The standard diagnostic method for compartment syndrome is an invasive intra-compartmental pressure measurement via insertion of a pressure monitoring device into the muscle compartment. Commercially available intra compartmental pressure monitors have a highly variable intra-observer reproducibility and user errors are common.
Compared to the invasive modalities, the Compremium Compartmental Compressibility Monitoring System (CPM#1) shows promising advantages for the clinical application. Not only is the technology used for the CPM#1 device safe and non-invasive for the patient with minimal training required for the healthcare professionals, but it has also demonstrated high intra- and inter-observer reproducibility (as per bench tests and clinical settings with prototypes, to be confirmed in clinical studies like this one). The use of the CPM#1 device therefore facilitates the measurements, as it is based on pre-existing ultrasound methods and avoids any further risks to the patients compared to invasive compartmental pressure diagnosis methods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPM#1 | Experimental | Compartment compressibility ratio measurement using the CPM#1 device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measurement of compartment compressibility | Device | Application of the CPM#1 device for compartment compressibility ratio measurement - 4 measurements on both legs of each healthy volunteer will be performed |
| Measure | Description | Time Frame |
|---|---|---|
| Inter-operator reproducibility with 3 raters | Inter-operator reproducibility will be assessed using intra-class correlation coefficients (two-way random effects, single rater, absolute agreement). Three independent raters will conduct one measurement on each of both legs of 21 volunteers. | During the procedure which should last about 10 min/patient |
| Measure | Description | Time Frame |
|---|---|---|
| Intra-operator reproducibility | Intra-operator reproducibility will be assessed using intra-class correlation coefficients (two-way mixed effects, single measurement, absolute agreement). One of the three independent raters will conduct two measurements on 42 legs (21 volunteers). | During the procedure which should last about 10 min/patient |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of adverse events | Safety of the procedure will be assessed by documenting adverse events (description of the adverse events, number of participants). | During the procedure which should last about 10 min/patient |
| Assessment of device deficiencies |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helen Anwander, Dr. med. | Department für Orthopädie und Traumatologie, Inselspital Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinik für Orthopädische Chirurgie und Traumatologie Inselspital | Bern | 3010 | Switzerland |
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| ID | Term |
|---|---|
| D003161 | Compartment Syndromes |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Investigators will be blinded to the measurement results.
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| Participant's reported pain: baseline |
Participant's reported pain will be assessed using a 0-100mm Visual Analogue Scale (VAS) at specific time points. |
| Before (5 min before procedure). |
| Participant's reported pain: at highest externally applied pressure | Participant's reported pain will be assessed using a 0-100mm Visual Analogue Scale (VAS) at specific time points. | During the procedure (the procedure will last about 10 min/patient) |
| Participant's reported pain: after the procedure | Participant's reported pain will be assessed using a 0-100mm Visual Analogue Scale (VAS) at specific time points. | Immediately after procedure (no follow up is planned) |
Safety of the procedure will be assessed by documenting device deficiencies (description)
| During the procedure which should last about 10 min/patient |
| New risk identification | Practitioner will be asked to identify risk due to the application of the device in patient care. | Within 12 hours after procedure (no follow up is planned) |