An observational study in Rib; Fracture, sponsored by Zimmer Biomet. Recruiting at 5 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-07.
Sponsored by Zimmer Biomet · Observational
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.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's planned enrollment of 167 is above the median of 100 across 675 observational studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Zimmer Biomet is the lead sponsor of 271 studies on the registry; 28 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 19 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients diagnosed with non-flail chest rib fractures who plan to receive surgical treatment with RibFix Blu Thoracic Fixation System or non-surgical treatment, and meet the inclusion criteria and do not meet any exclusion criteria will be eligible to participate in the study
Exclusion Criteria:
Any contraindications listed in the manufacturer's Instruction to use for RibFix Blu Thoracic Fixation System as per below:
Patients will receive analgesia and symptomatic management treatment
Device: Non surgical and Surgical
Patients will receive surgical treatment using RibFix Blu Thoracic Fixation System
Device: Non surgical and Surgical
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.
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
Pulmonary 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
Plan to share: No
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Zimmer Biomet