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Completed

NCT Number: NCT02132416

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Departement of Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NSAID

Drug

Will be used if tolerated.

Other names: Diclofenac, Naprosyn, Ibuprofen

Opioids

Drug

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

Other names: Tramadol, Oxycodone, Morphine

Thoracic Epidural anaesthesia

Drug

Given by specialists in anaesthesiology and intensive care.

Other names: Continous thoracic epidural anaesthesia will be offered.

Paracetamol

Drug

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

Other names: Paracet, Alvedon, Panodil

Surgical management

Procedure

Fracture stabilization

Other names: Matrix Rib Fixation System (DePuy Synthes).

Primary outcomes

  1. Respiratory insufficiency

    Time frame: 1 year

    Need and length of ventilation therapy

Secondary outcomes

  1. Hospital stay

    Time frame: 6 weeks

    Time spent in an intensive care unit and total length of hospital stay

Other outcomes

  1. Disability Rating Index

    Time frame: 1 year

    Pain, function and mobility

  2. Quality of Life; EQ5D5L and VAS

    Time frame: Time Frame

    EQ-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).

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Collaborators

  • Karolinska University Hospital

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
May 7, 2014
Registry last updated
Jan 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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