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The Surgical Treatment of Rib Fractures: a Randomised Controlled Trial

Management of Multiple Rib Fractures with Open Reduction and Internal Fixation: a Randomised Controlled Trial to Investigate Effect on Morbidity and Quality of Life.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12608000356369
Enrollment
100
Registered
2008-07-24
Start date
2008-09-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Rib fractures are a common injury. They can cause significant pain and lead to serious complications including death. Pain can affect the recovery from rib fracture, in particular how quickly a patient gets back to work or their activities of daily living. The aim of this study is to test the hypothesis that the operative management of patients with displaced (severe) rib fractures, via fixation of the fractures with an absorbable mesh plate, i) decreases the complications patients suffer from these injuries while in hospital, and ii) improves pain so that they can get back to work and normal activities quicker, and with an improved quality of life.

Interventions

Open reduction and internal fixation of rib fractures. Surgical approach: using thoracoscopy and muscle-sparing mini-thoracotomy incisions. Surgical technique: fixation with an absorbable polylactide copolymer mesh and screw system and vicryl sutures. Duration of surgery: 1.5 to 2.5 hours Associated supportive treatment: intervention such as ventilation (other than for the duration of general anaesthesia), epidural or intravenous analgesia delivery and physiotherapy determined by the patient's

Open reduction and internal fixation of rib fractures. Surgical approach: using thoracoscopy and muscle-sparing mini-thoracotomy incisions. Surgical technique: fixation with an absorbable polylactide copolymer mesh and screw system and vicryl sutures. Duration of surgery: 1.5 to 2.5 hours Associated supportive treatment: intervention such as ventilation (other than for the duration of general anaesthesia), epidural or intravenous analgesia delivery and physiotherapy determined by the patient's associated injuries and respiratory function. Patients will only be ventilated prior to surgery if they have respiratory failure. Duration of ventilation and duration of need for analgesia (other than oral analgesia) are variables that shall be measured and compared between groups. Period of overall intervention: patients will be reviewed in clinic for a minimum of 6 months. Duration of other specific treatments (other than surgery) such as analgesia shall be determined by patient need.

Sponsors

Phillip Antippa
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to 79 Years
Healthy volunteers
No

Inclusion criteria

Patients sustaining blunt chest trauma, with displaced fractures of two or more ribs

Exclusion criteria

Patients with severe head injuries (GCS (Glasgow coma Score)<9 on admission), abdominal, spinal or pelvic injuries prohibiting appropriate positioning for surgery, patients not expected to survive at 48 hours, pregnancy, patient or family decline to consent, no consent available, any other contraindication to surgery.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026