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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05146986




Registration number
NCT05146986
Ethics application status
Date submitted
15/10/2021
Date registered
7/12/2021

Titles & IDs
Public title
RibFix Blu Thoracic Fixation System Versus Non-surgical Treatment in Non-flail Chest Rib Fractures
Scientific title
Prospective Multi-center Comparative Study of RibFix Blu Thoracic Fixation System Versus Non-surgical Treatment in Non-flail Chest Rib Fractures
Secondary ID [1] 0 0
CSA2021-16SU
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rib; Fracture 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Fractures
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Non surgical and Surgical

Non-surgical group - Patients will receive analgesia and symptomatic management treatment

Surgical group - Patients will receive surgical treatment using RibFix Blu Thoracic Fixation System


Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Thoracic pain as assessed by numeric Rating Scale (NRS)
Timepoint [1] 0 0
2 weeks
Secondary outcome [1] 0 0
Rate of Analgesic use
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
Length of Hospital stay
Timepoint [2] 0 0
12 weeks
Secondary outcome [3] 0 0
Quality of life using EuroQoL-5L
Timepoint [3] 0 0
2 weeks, 6 weeks and 12 weeks
Secondary outcome [4] 0 0
Pulmonary function
Timepoint [4] 0 0
12 weeks
Secondary outcome [5] 0 0
Pulmonary function
Timepoint [5] 0 0
2 weeks, 6 weeks and 12 weeks
Secondary outcome [6] 0 0
Number of Participants with respiratory complications
Timepoint [6] 0 0
2 weeks, 6 weeks and 12 weeks

Eligibility
Key inclusion criteria
* Age 18 and above (inclusive)
* Simple rib fracture with = 3 consecutive ribs, and the broken ends showed clear displacements
* Indicated for surgical repair of rib fractures using RibFix Blu Thoracic Fixation System or non-surgical treatment (analgesia and symptomatic management treatment)
* Willing and able to complete scheduled follow-up evaluations as described in the study protocol
* Has participated in the Informed Consent process and is willing and able to sign an Institutional Review Board or Ethics Committee (IRB/EC) approved Patient Information/ Informed consent Form (PICF)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Flail chest rib fractures based on radiological or clinical findings
* Previous rib fractures or pulmonary problems, requiring continuous oxygen use at home pre-trauma
* Presence of any serious medical issues that placed patient in generally poor conditions such that he or she could not tolerate the surgery
* Chest trauma associated with severe craniocerebral injury, abdominal organ injury, severe spinal injury, limb fracture, or pelvic fracture requiring long-term bed rest
* Has serious medical disease that is a contraindication for general anesthesia, such as cerebral infarction, myocardial infarction and hemorrhagic syndrome
* Any contraindications listed in the manufacturer's Instruction to use for RibFix Blu Thoracic Fixation System as per below:

* Spanning a midline sternotomy
* Active Infection
* Foreign body sensitivity
* Is known to be pregnant
* Is a prisoner, known alcohol or drug user or mentally incompetent or unable to understand what participation in this study entails.
* Participation in another surgical intervention that may influence any of the outcome parameters.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/01/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2026
Actual
Sample size
Target
167
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Hunter New England Health District - Sydney
Recruitment hospital [2] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [3] 0 0
The Alfred (Alfred Health) - Melbourne
Recruitment postcode(s) [1] 0 0
2301 - Sydney
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
31004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Korea, Republic of
State/province [1] 0 0
Gangwon-do
Country [2] 0 0
Korea, Republic of
State/province [2] 0 0
Gyeonggi-do

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Zimmer Biomet
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Silvana Marasco, Professor
Address 0 0
The Alfred
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Irene Chong
Address 0 0
Country 0 0
Phone 0 0
97566687
Fax 0 0
Email 0 0
irene.chong@zimmerbiomet.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05146986