Prospective Follow up of Minimally Invasive Chest Wall Surgery After Trauma

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Follow-up of Patients Treated With Muscle Sparing, Minimally Invasive Open Surgical Technique for Unstable Chest Wall After Trauma

Conditions
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Rib; Fracture, Multiple, With Flail Chest

Intervention / Treatment
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* Procedure: Minimally invasive surgical fixation of unstable rib cage
* Procedure: Large incision surgical fixation of unstable rib cage.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Minimally invasive<br>Patients who underwent surgery with a muscle sparing, minimally invasive technique for unstable chest wall after trauma. | Procedure: Minimally invasive surgical fixation of unstable rib cage<br>* 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).<br>|
| Historical control<br>Patients who underwent surgery with large incisions and simultaneous thoracotomy for unstable chest wall after trauma. | Procedure: Large incision surgical fixation of unstable rib cage.<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital capacity of the lungs. | Vital capacity (VC) measured with spirometry. | One year after surgery. | 
| Forced vital capacity of the lungs. | Forced vital capacity (VC) measured with spirometry. | One year after surgery. | 
| Forced expiratory volume of the lungs. | Forced expiratory volume in 1 second (FEV1) measured with spirometry. | One year after surgery. | 
| Forced expiratory volume percent of the lungs. | Forced expiratory volume in 1 second divided with forced vital capacity, measured with spirometry. | One year after surgery. | 
| Peak expiratory flow of the lungs. | Peak expiratory flow measured with spirometry. | One year after surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability | Degree of disability assessed with Disability Rating Index (DRI) scale ranging from 0-100 where higher scores indicate more disability. | Six months and one year after surgery. | 
| Physical activity | Physical activity assessed with Grimby activity scale ranging from 1-6 where 6 indicates the highest level of activity. | Six months and one year after surgery. | 
| Shoulder mobility | Shoulder mobility assessed with Boström index, a scale ranging from 5-30 for each shoulder where 30 represents the greatest range of movement. | Six months and one year after surgery. | 
| Respiratory movement | Movement of chest wall during respiration measured with Respiratory Movement Measuring Instrument (RMMI). | Six months and one year after surgery. | 
| Strength of respiratory muscles | Strength of respiratory muscles measured with Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP). | Six months and one year after surgery. | 
| Quality of life EQ-5D-5L | 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. | Six months and one year after surgery. | 
| Radiological healing | 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. | One year after surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Minimally invasive, Chest wall, Trauma, Surgery, Muscle sparing