Rib; Fracture, Multiple, With Flail Chest
Conditions
Keywords
Chest wall, Trauma, Minimally invasive, Surgery, Muscle sparing
Brief summary
The purpose of this study is to assess the outcome of a muscle sparing, minimally invasive open surgical technique for unstable ribcage injuries after trauma. The investigators will compare the results from the study participants to a historical cohort who were operated with a different surgical technique with large incisions and simultaneous thoracotomy.
Detailed description
This is a prospective follow-up study where the investigators aim to study patients who have undergone surgery with a muscle sparing, minimally invasive technique for unstable ribcage after trauma. The investigators plan on seeing the participants as out patients 6 months and 1 year after surgery. The results will be compared to results from a historical cohort with patients who participated in earlier studies with a different surgical method with large incisions and simultaneous thoracotomy. The investigators plan on including 50 patients since a preliminary analysis has suggested this should be enough to notice statistically significant differences between the groups.
Interventions
PROCEDUREMinimally invasive surgical fixation of unstable rib cage
Minimally invasive and muscle sparing surgical fixation of ribs and/or sternum in an unstable segment of the chest wall (flail chest) with titan plates or medullary nails (MatrixRib Fixation System, DepuySynthes).
PROCEDURELarge incision surgical fixation of unstable rib cage.
Surgical fixation of ribs and/or sternum in an unstable segment of the chest wall (flail chest) with titan plates or medullary nails (MatrixRib Fixation System, DepuySynthes). Large non muscle sparing incision with simultaneous thoracotomy.
Sponsors
Sahlgrenska University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with chest wall trauma who underwent surgical stabilisation for unstable chest wall using a minimally invasive, muscle sparing technique without thoracotomy or thoracoscopy no more than 6 months prior to inclusion.
Exclusion criteria
* Severe head injury (Abbreviated Injury score (AIS) \>3) * Spinal injury * Neurological or musculoskeletal disease affecting chest wall mobility
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vital capacity of the lungs. | One year after surgery. | Vital capacity (VC) measured with spirometry. |
| Forced vital capacity of the lungs. | One year after surgery. | Forced vital capacity (VC) measured with spirometry. |
| Forced expiratory volume of the lungs. | One year after surgery. | Forced expiratory volume in 1 second (FEV1) measured with spirometry. |
| Forced expiratory volume percent of the lungs. | One year after surgery. | Forced expiratory volume in 1 second divided with forced vital capacity, measured with spirometry. |
| Peak expiratory flow of the lungs. | One year after surgery. | Peak expiratory flow measured with spirometry. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disability | Six months and one year after surgery. | Degree of disability assessed with Disability Rating Index (DRI) scale ranging from 0-100 where higher scores indicate more disability. |
| Physical activity | Six months and one year after surgery. | Physical activity assessed with Grimby activity scale ranging from 1-6 where 6 indicates the highest level of activity. |
| Shoulder mobility | Six months and one year after surgery. | Shoulder mobility assessed with Boström index, a scale ranging from 5-30 for each shoulder where 30 represents the greatest range of movement. |
| Respiratory movement | Six months and one year after surgery. | Movement of chest wall during respiration measured with Respiratory Movement Measuring Instrument (RMMI). |
| Strength of respiratory muscles | Six months and one year after surgery. | Strength of respiratory muscles measured with Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP). |
| Quality of life EQ-5D-5L | Six months and one year after surgery. | Quality of life assessed with the EuroQol (European Quality of Life) Five Dimension Five Level Scale (EQ-5D-5L). A 5-dimensional scale in which each dimension has 5 levels where 1 represents the best outcome and 5 represents the worst outcome. |
| Radiological healing | One year after surgery. | Radiological signs of healing of the participants rib fractures assessed with CT scan. Fractures will be denoted as healed, partially healed or with no signs of healing. |
Countries
Sweden
Contacts
PRINCIPAL_INVESTIGATORErik Westin, MD
Sahlgrenska University Hospital
Outcome results
None listed