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Trial registered on ANZCTR


Registration number
ACTRN12615001040550
Ethics application status
Approved
Date submitted
2/09/2015
Date registered
7/10/2015
Date last updated
7/10/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the impact of surgical repair of rib fractures compared to non surgical management of rib fractures on pain and quality of life.
Scientific title
Evaluation of the impact of operative fixation of displaced rib fractures compared to non surgical management of rib fractures on pain and quality of life.
Secondary ID [1] 287397 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
fractured ribs 296103 0
Condition category
Condition code
Surgery 296357 296357 0 0
Surgical techniques
Injuries and Accidents 296425 296425 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will look specifically at patients with multiple painful broken ribs and surgical fixation of displaced ribs using plates and screws as required to hold fractured ribs in the correct position to allow healing - these plates and screws remain in situ after healing. The duration of the surgery to repair the fractured ribs will depend upon the individual injury and be performed by a qualified cardiothoracic surgeon. We will compare a group treated with an operation to fix the broken ribs with plates and screws to a group treated with pain control and full supportive measures that are currently our standard of care. Study Participant's Quality of life and recovery from injury will be followed up in the months after treatment for the rib fractures.
Intervention code [1] 292748 0
Treatment: Surgery
Intervention code [2] 292749 0
Rehabilitation
Comparator / control treatment
Non surgical medical management of rib fractures.
This may include pain relief medications, oxygen support and mechanical ventilation
Control group
Active

Outcomes
Primary outcome [1] 296007 0
Pain and disability at 3 months post injury (composite endpoint assessed using McGill Pain Questionnaire and SF12 Questionnaire)

Timepoint [1] 296007 0
3 months post injury
Secondary outcome [1] 317220 0
*Pain control / analgesic requirements (Assessed by auditing the use of narcotic drugs and other analgesics)





Timepoint [1] 317220 0
6 and 12 months post injury
Secondary outcome [2] 317734 0
*(Composite endpoint) Non-invasive ventilator requirements / respiratory complications during hospital stay (eg. pneumonia, pneumothorax (barotrauma), tracheostomy insertion, intercostal catheter usage and duration, readmission to ICU) (assessed by review of hospital records)
Timepoint [2] 317734 0
6 & 12 months post injury
Secondary outcome [3] 317735 0
*Incidence of wound complications related to the rib fixation
(assessment by review of patient medical records)
Timepoint [3] 317735 0
6 & 12 months post injury
Secondary outcome [4] 317736 0
*Hospital length of stay (assessment by review of patient medical records)
Timepoint [4] 317736 0
6 & 12 months post injury
Secondary outcome [5] 317737 0
*Mortality (assessment by review of patient medical records)
Timepoint [5] 317737 0
6 & 12 months post injury
Secondary outcome [6] 317738 0
*Discharge destination (assessment by review of patient medical records)
Timepoint [6] 317738 0
6 & 12 months post injury
Secondary outcome [7] 317739 0
*Work or usual activity days lost - Patients will be questioned about their return to work and the type of work activity they are performing. (i.e. full time, part time, manual labour, desk duties etc) Assessed during Patient clinical review at 6 & 12 months
Timepoint [7] 317739 0
6 & 12 months post injury
Secondary outcome [8] 317740 0
*Pain and quality of life at 6 and 12 months (composite endpoint)
Quality of Life is Assessed using the SF12 Questionnaire
Pain is assessed using the McGill Pain Questionnaire
Timepoint [8] 317740 0
6 & 12 months post injury

Eligibility
Key inclusion criteria
*Previously functionally independent patients with multiple, closed fractured ribs between the level of ribs 3 to 10 confirmed on CXR and CT chest.
*Uncontrolled pain from fractured ribs and/ or displaced fractured ribs
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Pre-injury dependency requiring ADL support
*Invasive ventilator support at the time of referral (patients will not be excluded if they deteriorate and require invasive ventilator support after initial referral)
*Spinal injuries which would preclude placement of the patient in a lateral decubitus position
*Open rib fractures with soiling or infection
*Severe head injury
*Uncorrected coagulopathy
*Adult respiratory distress syndrome
*Uncorrected Sepsis
*Pregnancy
*Immunocompromised patients including those who are steroid dependent
*Known opiate dependency
*Age< 18 years or >85 years

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be recruited from the Alfred Trauma Service. Any patients with rib fractures, admitted under the trauma unit will be referred to the cardiothoracic surgery unit for screening. Patients who fulfill the entry criteria for this study will be enrolled. Patients will be randomised via selection of a sealed opaque envelope to operative or non operative arms.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer program will be used to generate the Randomisation sequence.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Pain and disability at three months post injury is the primary endpoint therefore sample size calculation will be based on that.
Using results of the relevant study by Fabricant (2013), sample size calculation has been completed using MPQ-PRI index scores for patients with rib fracture treated conservatively, population mean 28 + 16 during index admission, reducing to mean 10.6 +- 10.9 sd @ 60 days (n=187) CI 95% = 1.56. In that study, Fabricant assumed a reduction in MPQ-PRI score to less than 8 correlated with a good reduction in pain to allow return to normal duties. Using that data, and assuming an a of 0.05 and power of 0.8 to detect a difference in MPQ-PPI, MPQ-PRI index scores, 21 patients per group will be needed. To allow for drop out in the follow up phase of the study, 25 participants per group will be recruited to ensure adequate sample size for analysis at study completion.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 4295 0
The Alfred - Prahran
Recruitment postcode(s) [1] 10232 0
3181 - Prahran

Funding & Sponsors
Funding source category [1] 291963 0
Self funded/Unfunded
Name [1] 291963 0
Address [1] 291963 0
Country [1] 291963 0
Primary sponsor type
Hospital
Name
Alfred Health
Address
55 Commercial Road
Melbourne 3004
Victoria
Country
Australia
Secondary sponsor category [1] 290632 0
None
Name [1] 290632 0
Address [1] 290632 0
Country [1] 290632 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293461 0
The Alfred Human Research Ethics Committee (EC00315)
Ethics committee address [1] 293461 0
The Alfred Hospital
55 Commercial Road
Melbourne 3004
Victoria
Ethics committee country [1] 293461 0
Australia
Date submitted for ethics approval [1] 293461 0
Approval date [1] 293461 0
24/03/2015
Ethics approval number [1] 293461 0
510/14

Summary
Brief summary
The optimal management of patients with fractured ribs who are not ventilator dependent has still not been determined. Although various studies suggest improvements in both short and long term function in patients who are treated by operative stabilization, there is not enough good evidence to advise management practices. However, the evidence available suggests that significant improvements in patient management and long term outcomes could be achieved by surgical fixation of ribs in these patients. A definitive answer will only be achieved by a prospective trial examining the short-term and longer term outcomes for patients treated by operative stabilization of their rib fractures
This study aims to assess early and late outcomes in patients with multiple painful displaced fractured ribs with and without operative fixation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60018 0
A/Prof Silvana Marasco
Address 60018 0
The Alfred Department of Cardiothoracic Surgery
55 Commercial road
Melbourne 3004
Victoria
Country 60018 0
Australia
Phone 60018 0
+61390763313
Fax 60018 0
Email 60018 0
s.marasco@alfred.org.au
Contact person for public queries
Name 60019 0
A/Prof Silvana Marasco
Address 60019 0
The Alfred Department of Cardiothoracic Surgery
55 Commercial road
Melbourne 3004
Victoria
Country 60019 0
Australia
Phone 60019 0
+61390763313
Fax 60019 0
Email 60019 0
s.marasco@alfred.org.au
Contact person for scientific queries
Name 60020 0
A/Prof Silvana Marasco
Address 60020 0
The Alfred Department of Cardiothoracic Surgery
55 Commercial road
Melbourne 3004
Victoria
Country 60020 0
Australia
Phone 60020 0
+61390763313
Fax 60020 0
Email 60020 0
s.marasco@alfred.org.au

No information has been provided regarding IPD availability
Summary results
No Results