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

NCT ID: NCT02132416

Last Updated: 2019-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2018-12-31

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.

Conditions

Trauma; Flail Chest; Rib Fractures; Surgery

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Surgical management

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.

Group Type: ACTIVE_COMPARATOR

NSAID

Intervention Type: DRUG

Will be used if tolerated.

Opioids

Intervention Type: DRUG

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

Thoracic Epidural anaesthesia

Intervention Type: DRUG

Given by specialists in anaesthesiology and intensive care.

Paracetamol

Intervention Type: DRUG

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

Surgical management

Intervention Type: PROCEDURE

Fracture stabilization

Conservative management

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.

Group Type: ACTIVE_COMPARATOR

NSAID

Intervention Type: DRUG

Will be used if tolerated.

Opioids

Intervention Type: DRUG

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

Thoracic Epidural anaesthesia

Intervention Type: DRUG

Given by specialists in anaesthesiology and intensive care.

Paracetamol

Intervention Type: DRUG

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

Interventions

NSAID

Will be used if tolerated.

Intervention Type: DRUG

Opioids

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

Intervention Type: DRUG

Thoracic Epidural anaesthesia

Given by specialists in anaesthesiology and intensive care.

Intervention Type: DRUG

Paracetamol

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

Intervention Type: DRUG

Surgical management

Fracture stabilization

Intervention Type: PROCEDURE

Other Intervention Names

Diclofenac; Naprosyn; Ibuprofen; Tramadol; Oxycodone; Morphine; Continous thoracic epidural anaesthesia will be offered.; Paracet; Alvedon; Panodil; Matrix Rib Fixation System (DePuy Synthes).

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska University Hospital

OTHER

Sponsor Role: collaborator

Sahlgrenska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Eva-Corina Caragounis

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hans Granhed, MD PhD

Role: STUDY_DIRECTOR

Sahlgrenska University Hospital

Eva-Corina Caragounis, MD

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital

Locations

Departement of Surgery, Sahlgrenska University Hospital

Gothenburg, , Sweden

Departement of Intensive Care, Karolinska University Hospital

Stockholm, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 40375321 (View on PubMed)

Other Identifiers

epn887-13

Identifier Type: REGISTRY

Identifier Source: secondary_id

ec761218

Identifier Type: -

Identifier Source: org_study_id