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Operative Treatment of Unstable Thoracic Cage Injuries and Chest Wall Deformity in Trauma

Prospective Controlled Study of Surgical Management of Unstable Thoracic Cage Injuries and Chest Wall Deformity in Trauma

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02132416
Enrollment
92
Registered
2014-05-07
Start date
2014-05-31
Completion date
2018-12-31
Last updated
2019-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trauma, Flail Chest, Rib Fractures, Surgery

Keywords

Prospective study, Surgical management, Unstable thoracic cage injuries, Trauma, Ventilator support

Brief summary

The purpose of this prospective controlled study is to determine whether surgical management of unstable thoracic cage injuries and chest wall deformity in trauma reduces the need for and the time spent on ventilator compared to a group treated without operation.

Detailed description

Patients meeting the inclusion criteria and giving their informed consent will be enrolled in this prospective controlled study. Included patients at Sahlgrenska University Hospital will undergo surgical stabilization of chest wall injuries and patients at Karolinska University Hospital will be managed conservatively. A total of 60 patients will be included in each group. 3D reconstructions of computed tomography images of the Thorax done at admission to the hospital will be used in order to evaluate injury according to Lung Injury Scale and Chest wall Injury Scale and for calculating radiological lung volumes and plan surgical procedure in the intervention group. Surgery will be performed as soon as possible after inclusion. MatrixRIB® (DePuy Synthes) Fixation system is used for stabilizing rib fractures with plates and angular locked screws. In cases where thoracotomy is done the patients will receive an anterior and posterior chest tube and wound drain with active suction. All patients, both in the intervention and in the control group will be offered thoracic epidural anaesthesia. Broad-spectrum intravenous antibiotic therapy is given as long as the patient has chest tubes. Thrombotic prophylaxis with LMWH is given until the patient is mobilized but for a minimum of 7 days. Patients will be followed-up 6 weeks, 6 months and 1 year post-operatively by surgeon and physiotherapist. A low-dosage computer tomography of the thorax will be done after 6 months in order to evaluate healing of the rib cage, possible non-union or dysfunction of osteosynthetic material and measure remaining lung volume. This examination will be compared to the initial computer tomography image done when the patient was admitted. At follow-ups complaints, possible late complications, usage of analgesia and return to work will be recorded. Evaluated instruments, EQ-5D-5L, VAS with Pain-O-Meter (POM) and Disability Rating Index (DRI) will be used to evaluate quality of life, pain and physical function. Range of motion in the thorax, thoracic spine and shoulders will be evaluated for every patient. Breathing movements will be measured by using a Respiratory movement measuring instrument (RMMI, ReMo Inc) and lung function tests will be performed in a standardized manner. In order to enrich the material, hospital data from patients fulfilling the inclusion criteria but not included, at the two study locations, during the inclusion period (June 2014 - June 2017) will be analyzed. An additional Ethical approval has been granted.

Interventions

DRUGNSAID

Will be used if tolerated.

DRUGOpioids

Initially intravenous administration and when tolerated oral slow-release pils will be used.

DRUGThoracic Epidural anaesthesia

Given by specialists in anaesthesiology and intensive care.

DRUGParacetamol

1g QID will be given to all patients unless allergies.

Fracture stabilization

Sponsors

Karolinska University Hospital
CollaboratorOTHER
Sahlgrenska University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Trauma with segmental rib fractures on at least 3 adjacent ribs ( anatomical flail chest ) * Trauma with chest wall deformity

Exclusion criteria

* Concurrent spinal cord injuries with paralysis * Severe head injury where normal level of consciousness is not resumed * Severe neurological and musculoskeletal diseases that influence the function of the thoracic wall and lung volumes

Design outcomes

Primary

MeasureTime frameDescription
Respiratory insufficiency1 yearNeed and length of ventilation therapy

Secondary

MeasureTime frameDescription
Hospital stay6 weeksTime spent in an intensive care unit and total length of hospital stay

Other

MeasureTime frameDescription
Disability Rating Index1 yearPain, function and mobility
Quality of Life; EQ5D5L and VASTime FrameEQ-5D-5L instrument has a subscale of; 1 (no problems), 2 (slight problems), 3 (moderate problems), 4 (severe problems) and 5 (extreme problems). The Visual Analogue scale is a self-rating scale from 0% (the worst Health you can imagine) to 100% (the best Health you can imagine).

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026