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| Name | Class |
|---|---|
| Medical Research Council of Southeast Sweden | OTHER_GOV |
| Helsinki University Central Hospital | OTHER |
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This prospective multinational, multicentre cohort study aims to investigate the hypothesis that biomarkers of muscle cell damage can predict acute compartment syndrome in patients with tibial fractures.
Patients with a tibial fracture are included. P-myoglobin and P-creatine phosphokinase are analysed at 6-hourly intervals pre- and if applicable, postoperatively after surgical fixation or fasciotomy. Also, blood samples will be collected in 6 hourly intervals if acute compartment syndrome is suspected. An expert panel of senior orthopaedic surgeons will retrospectively assess study data and classify patients who had undergone fasciotomy into those with and without acute compartment syndrome.
Blood samples will also be collected in patients with acute compartment syndrome without tibial fractures, to serve as a positive control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tibial fracture | Patients with a traumatic tibial fracture and without acute compartment syndrome. |
| |
| Tibial fracture complicated by acute compartment syndrome | Patients with a tibial fracture and acute compartment syndrome of fractured leg. |
| |
| Acute compartment syndrome without fracture | Patients with acute compartment syndrome but without a fracture. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood samples and biopsies | Other | Blood samples for analysis of biomarkers of muscle damage. Muscle biopsies for histological analysis of muscle damage. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak levels of P-myoglobin and P-creatine phosphokinase | A series of blood samples will be collected with 6-hourly interval at the following time-points:
Acute compartment syndrome: If suspicion of acute compartment syndrome emerges, blood samples will be collected with 6-hourly interval until fasciotomy is performed or the suspicion is written off. After fasciotomy, blood samples will be continued with 6-hourly interval for 24 hours. | Up to 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| MicroRNA | We also collect microRNA specific for muscle damage at the same time intervals and use it as an objective measures of muscle damage. | Up to 5 days |
| Histological evidence of muscle damage |
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Tibial fracture group
Inclusion Criteria:
- Traumatic tibial fracture
Exclusion Criteria:
Non-fracture group
Inclusion Criteria:
- Suspected acute compartment syndrome
Exclusion Criteria:
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Patients with a traumatic tibial fracture with or without other concomitant fractures and patients with suspected acute compartment syndrome. The study population is sampled in a consecutive way.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jörg Schilcher, MD, PhD | Contact | +46101030000 | jorg.schilcher@liu.se | |
| Abraham Nilsson, MD | Contact | +46101030000 | abraham.nilsson@regionostergotland.se |
| Name | Affiliation | Role |
|---|---|---|
| Jörg Schilcher, PhD | University Hospital, Linkoeping | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital of Linkoping | Recruiting | Linköping | 581 85 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35501102 | Derived | Nilsson A, Ibounig T, Lyth J, Alkner B, von Walden F, Fornander L, Ramo L, Schmidt A, Schilcher J. BioFACTS: biomarkers of rhabdomyolysis in the diagnosis of acute compartment syndrome - protocol for a prospective multinational, multicentre study involving patients with tibial fractures. BMJ Open. 2022 May 2;12(5):e059918. doi: 10.1136/bmjopen-2021-059918. |
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| ID | Term |
|---|---|
| D013978 | Tibial Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Blood samples, muscle biopsies
At surgery (internal fixation or fasciotomy) biopsies are taken from tibialis anterior muscle in some centres for further histological analysis. Two biopsies are taken from the fractured leg, one near the fracture and one at distance, and one biopsy from the uninjured leg (control). Biopsies are frozen within 30 minutes using liquid nitrogen and isopentane and stored in minus 80 degrees Celsius.
| At internal fixation and/or fasciotomy |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D003949 | Diagnostic Techniques, Surgical |