Surgery for Unstable Chest Wall Injuries - How Many Fractures Should be Fixed?

NCT07338656 | Not Yet Recruiting

• 1 other identifier: 286203
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rib Fracture Multiple; Flail Chest

Keywords

Rib Fractures; Flail Chest; Traumatology; Comparative Study

Outcome Measures

Primary Outcomes (1)

• Radiological healing

  Fracture healing on CT described as "union", "non-union" or "partial union" by radiologist.

  3 months after inclusion, 12 months after inclusion if not healed after 3 months.

Secondary Outcomes (10)

• Postoperative pain (opioids)

  1, 2, 3 days postoperatively and 1, 3, 12 months postoperatively.

• Postoperative pain (visual analogue scale)

  1, 2, 3 days postoperatively and 1, 3, 12 months postoperatively.

• Postoperative pain (graphical representation)

  1, 2, 3 days postoperatively and 1, 3, 12 months postoperatively.

• Lung function with spirometry

  1, 3 and 12 months after inclusion.

• Complications

  Up to 12 months after inclusion.

Study Arms (2)

Stabilization of two fractures per rib

EXPERIMENTAL

Procedure: Surgical stabilization of two fractures per rib

Stabilization of one fracture per rib

ACTIVE COMPARATOR

Procedure: Surgical stabilization of one fracture per rib.

Interventions

Surgical stabilization of one fracture per rib. PROCEDURE

Surgical stabilization of one fracture per rib in an unstable chest wall segment.

Stabilization of one fracture per rib

Surgical stabilization of two fractures per rib PROCEDURE

Surgical stabilization of two fractures per rib in an unstable chest wall segment.

Stabilization of two fractures per rib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Related Publications (23)

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MeSH Terms

Conditions

Flail Chest; Rib Fractures

Condition Hierarchy (Ancestors)

Thoracic Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Eva-Corina Caragounis, Ph.D, Ass. Prof

  Institution of Clinical Sciences, Sahlgrenska Academy, Gothenburg University. Department of Surgery, Sahlgrenska University Hospital

  STUDY DIRECTOR

Central Study Contacts

Erik Westin, MD

CONTACT

+46313426161; erik.westin@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: January 14, 2026
• Study Start: May 5, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-01

Locations

SE (1)