This is a prospective, multi-center, observational, cohort study involving skilled cardiothoracic surgeons who are experienced in implanting the treatment of non-flail chest rib fractures and the use of RibFix Blu Thoracic Fixation System.
The objective of this study is to evaluate the benefits of surgical stabilization of rib fractures (SSRF) in patients with non-flail chest rib fractures using RibFix Blu Thoracic Fixation System when compared to non-surgical (analgesia and symptomatic management) treatment. The study will include up to 167 cases of non-flail chest rib fractures with 95 cases in non-surgical treatment group and 72 cases in the surgical group. Each center may enroll up to maximum 30 cases to permit the assessment of outcome across a variety investigators and clinical settings. Enrolment will be competitive among sites and closed as soon as a total of 167 cases are recruited.
Study Type
OBSERVATIONAL
Enrollment
167
For non-surgical group, patients will receive non-surgical treatment (analgesia and symptomatic management treatment). For surgical group, patients will receive surgical treatment using RibFix Blu Thoracic Fixation System.
Hunter New England Health District
Sydney, New South Wales, Australia
NOT_YET_RECRUITINGFlinders Medical Centre
Bedford Park, South Australia, Australia
RECRUITINGThe Alfred (Alfred Health)
Melbourne, Victoria, Australia
Thoracic pain as assessed by numeric Rating Scale (NRS)
Level of thoracic pain determined using a numeric Rating Scale (NRS). Thoracic pain will be determined using an 11-point Numeric Rating Scale (NRS) in which 0 implicates no pain and 10 the worst pain. If a subject is not able to provide a response to the level of thoracic pain,
Time frame: 2 weeks
Rate of Analgesic use
Analgesic use by the difference groups
Time frame: 12 weeks
Length of Hospital stay
Length of Hospital stay by the difference groups
Time frame: 12 weeks
Quality of life using EuroQoL-5L
Health related qualify of life using EuroQoL-5L(EQ-5D-5L) questionnaires from the different groups. A standardized measure of health-related quality of life states consisting of 5 dimensions, namely mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D-5L version was used in the study. Each dimension has 5 responses recording 5 levels of severity (no problems/slight problems/moderate problems/severe problems or extreme problems). The responses to the EQ-5D dimensions are used to obtain a single EQ-5D index value where 1 represents full health and 0 represents death. The questionnaire also includes a vertical, visual analogue scale (EQ VAS) for the respondents to record their self-rated health where the 2 extreme ends of the scale are labelled as 'Best imaginable health state' and 'Worst imaginable health state' respectively
Time frame: 2 weeks, 6 weeks and 12 weeks
Pulmonary function
Pulmonary function will be assessed by the measuring the forced vital capacity (FVC) using a spirometer.
Time frame: 12 weeks
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Yonsei Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, South Korea
RECRUITINGAjou University Hospital
Suwon, Gyeonggi-do, South Korea
RECRUITINGPulmonary function
Pulmonary function will be assessed by the measuring the forced expiratory volume (FEV) using a spirometer.
Time frame: 2 weeks, 6 weeks and 12 weeks
Number of Participants with respiratory complications
Complications from the different groups assessed to be related to respiratory.
Time frame: 2 weeks, 6 weeks and 12 weeks