Acute Compartment Syndrome, Tibia Fracture
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERBlood samples and biopsies
Blood samples for analysis of biomarkers of muscle damage. Muscle biopsies for histological analysis of muscle damage.
Sponsors
Medical Research Council of Southeast Sweden
Helsinki University Central Hospital
University Hospital, Linkoeping
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Tibial fracture group Inclusion Criteria: \- Traumatic tibial fracture
Exclusion criteria
* Malignancy * Acute myocardial infarction * Kidney failure (GFR ≤35 ml/min) * Muscle disease * Paraplegia/tetraplegia Non-fracture group Inclusion Criteria: \- Suspected acute compartment syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak levels of P-myoglobin and P-creatine phosphokinase | Up to 5 days | A series of blood samples will be collected with 6-hourly interval at the following time-points: * Admission to hospital: P-myoglobin and P-creatine phosphokinase are collected at 6-hourly intervals for a maximum of 48 hours or until definitive surgical fixation of the fracture is performed (temporary external fixation excluded). * Surgical fracture treatment: After surgical intervention (definitive surgical fracture treatment, excluding temporary external fixation), another series of blood samples is collected with 6-hourly interval for 24 hours. 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MicroRNA | Up to 5 days | We also collect microRNA specific for muscle damage at the same time intervals and use it as an objective measures of muscle damage. |
| Histological evidence of muscle damage | At internal fixation and/or fasciotomy | 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. |
Countries
Sweden
Contacts
Primary ContactJörg Schilcher, MD, PhD
Backup ContactAbraham Nilsson, MD
Outcome results
None listed