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

NCT02132416 | Completed DMC

• 2 other identifiers: ec761218epn887-13
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 2

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.

Conditions

Trauma; Flail Chest; Rib Fractures; Surgery

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Respiratory insufficiency

  Need and length of ventilation therapy

  1 year

Secondary Outcomes (1)

• Hospital stay

  6 weeks

Other Outcomes (2)

• Disability Rating Index

  1 year

• Quality of Life; EQ5D5L and VAS

  Time Frame

Study Arms (2)

Surgical management

ACTIVE COMPARATOR

Operative fixation of unstable thoracic cage injuries and chest wall deformity. Thoracic Epidural anaesthesia will be offered. Paracetamol, Opioids and NSAID will be used as pain medication.

Drug: NSAID; Drug: Opioids; Drug: Thoracic Epidural anaesthesia; Drug: Paracetamol; Procedure: Surgical management

Conservative management

ACTIVE COMPARATOR

Conservative management of unstable thoracic cage injuries and chest wall deformity. Thoracic epidural anaesthesia will be offered. Paracetamol, Opioids and NSAID will be used as pain medication.

Drug: NSAID; Drug: Opioids; Drug: Thoracic Epidural anaesthesia; Drug: Paracetamol

Interventions

NSAID DRUG

Will be used if tolerated.

Also known as: Diclofenac, Naprosyn, Ibuprofen

Conservative management; Surgical management

Opioids DRUG

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

Also known as: Tramadol, Oxycodone, Morphine

Conservative management; Surgical management

Thoracic Epidural anaesthesia DRUG

Given by specialists in anaesthesiology and intensive care.

Also known as: Continous thoracic epidural anaesthesia will be offered.

Conservative management; Surgical management

Paracetamol DRUG

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

Also known as: Paracet, Alvedon, Panodil

Conservative management; Surgical management

Surgical management PROCEDURE

Fracture stabilization

Also known as: Matrix Rib Fixation System (DePuy Synthes).

Surgical management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead
• Karolinska University Hospital: collaborator

Study Sites (2)

Departement of Surgery, Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Location

Departement of Intensive Care, Karolinska University Hospital

Stockholm, 171 76, Sweden

Location

Related Publications (1)

• Caragounis EC, Fagevik Olsen M, Sandstrom L, Rossi Norrlund R, Strommer L, Granhed H. A bi-institutional observational study comparing short-term and long-term outcome of operative and non-operative management of clinical and radiological flail chest injuries. Scand J Trauma Resusc Emerg Med. 2025 May 15;33(1):87. doi: 10.1186/s13049-025-01400-8.

  PMID: 40375321 DERIVED

MeSH Terms

Conditions

Wounds and Injuries; Flail Chest; Rib Fractures

Interventions

Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Naproxen; Ibuprofen; Analgesics, Opioid; Tramadol; Oxycodone; Morphine; Acetaminophen

Condition Hierarchy (Ancestors)

Thoracic Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Phenylpropionates; Narcotics; Central Nervous System Depressants; Central Nervous System Agents; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Amines; Lipids; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Acetanilides; Anilides; Amides; Aniline Compounds

Study Officials

• Hans Granhed, MD PhD

  Sahlgrenska University Hospital

  STUDY DIRECTOR

• Eva-Corina Caragounis, MD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 1, 2014
• First Posted: May 7, 2014
• Study Start: May 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2018
• Last Updated: January 16, 2019

Record last verified: 2019-01

Locations

SE (2)