Surgery for Unstable Chest Wall Injuries - How Many Fractures Should be Fixed?
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSahlgrenska University Hospital
About this trial
The goal of this prospective, randomized study is to learn about the effects of two different surgical techniques for treating unstable chest wall injuries in adults. The main questions it aims to answer are:
Does fixing two fractures per rib lead to better healing than fixing one fracture per rib in patients with unstable chest injuries? Does the choice of surgical method affect lung function, pain, other symptoms, risk of pneumonia, or the risk of complications?
Participants will:
* Undergo surgery using either the standard method (fixing one fracture per rib) or an alternative method (fixing two fractures per rib), both using a muscle-sparing technique. * Be followed up at 1, 3, and 12 months after surgery. * Have CT scans at 3 months (and at 12 months if healing is incomplete) to assess bone healing. * Be evaluated for lung function, pain, symptoms, and complications.
This study aims to provide new knowledge about which surgical method is best for unstable chest wall injuries, helping to improve treatment and recovery for these patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients scheduled for surgery of acute (≤7 days after trauma) unstable injuries in the chest wall at the Department of Surgery, Sahlgrenska University Hospital
Both parts of the unstable segment must be accessible for surgery.
Disqualifiers
Patients with injuries resulting from CPR
Patients with severe head injury (Head AIS>3)
Patients with spinal injury
Patients with neurological or musculoskeletal disease affecting chest wall mobility.
Trial design
Design model
Parallel
Treatments tested in this trial
Surgical stabilization of two fractures per rib
Procedure/SurgerySurgical stabilization of two fractures per rib in an unstable chest wall segment.
Surgical stabilization of one fracture per rib.
Procedure/SurgerySurgical stabilization of one fracture per rib in an unstable chest wall segment.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Stabilization of two fractures per ribExperimental treatment 1 intervention
Group B: Stabilization of one fracture per ribActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Radiological healing
Fracture healing on CT described as "union", "non-union" or "partial union" by radiologist.
Time frame
3 months after inclusion, 12 months after inclusion if not healed after 3 months.Secondary outcomes
1
Postoperative pain (opioids)
Pain assessed with opioid equivalents
Time frame
1, 2, 3 days postoperatively and 1, 3, 12 months postoperatively.2
Postoperative pain (visual analogue scale)
Pain assessed with a visual analogue scale.
Time frame
1, 2, 3 days postoperatively and 1, 3, 12 months postoperatively.3
Postoperative pain (graphical representation)
Pain assessed with a graphical representation of the human body where areas of pain can be indicated by the participant.
Time frame
1, 2, 3 days postoperatively and 1, 3, 12 months postoperatively.4
Lung function with spirometry
Lung function measured with spirometry. Predicted FVC will be the outcome measure.
Time frame
1, 3 and 12 months after inclusion.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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