Prospective Follow up of Minimally Invasive Chest Wall Surgery After Trauma

April 27, 2026 updated by: Erik Öberg Westin, Sahlgrenska University Hospital

A Prospective Follow-up of Patients Treated With Muscle Sparing, Minimally Invasive Open Surgical Technique for Unstable Chest Wall After Trauma

The purpose of this study is to assess the outcome of a muscle sparing, minimally invasive open surgical technique for unstable ribcage injuries after trauma. The investigators will compare the results from the study participants to a historical cohort who were operated with a different surgical technique with large incisions and simultaneous thoracotomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective follow-up study where the investigators aim to study patients who have undergone surgery with a muscle sparing, minimally invasive technique for unstable ribcage after trauma. The investigators plan on seeing the participants as out patients 6 months and 1 year after surgery. The results will be compared to results from a historical cohort with patients who participated in earlier studies with a different surgical method with large incisions and simultaneous thoracotomy. The investigators plan on including 50 patients since a preliminary analysis has suggested this should be enough to notice statistically significant differences between the groups.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden
        • Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients surgically treated at our trauma ward for unstable chest wall due to trauma. Consecutive sampling.

Description

Inclusion Criteria:

  • Patients with chest wall trauma who underwent surgical stabilisation for unstable chest wall using a minimally invasive, muscle sparing technique without thoracotomy or thoracoscopy no more than 6 months prior to inclusion.

Exclusion Criteria:

  • Severe head injury (Abbreviated Injury score (AIS) >3)
  • Spinal injury
  • Neurological or musculoskeletal disease affecting chest wall mobility

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Minimally invasive
Patients who underwent surgery with a muscle sparing, minimally invasive technique for unstable chest wall after trauma.
Procedure: Minimally invasive surgical fixation of unstable rib cage
Minimally invasive and muscle sparing surgical fixation of ribs and/or sternum in an unstable segment of the chest wall (flail chest) with titan plates or medullary nails (MatrixRib Fixation System, DepuySynthes).
Historical control
Patients who underwent surgery with large incisions and simultaneous thoracotomy for unstable chest wall after trauma.
Procedure: Large incision surgical fixation of unstable rib cage.
Surgical fixation of ribs and/or sternum in an unstable segment of the chest wall (flail chest) with titan plates or medullary nails (MatrixRib Fixation System, DepuySynthes). Large non muscle sparing incision with simultaneous thoracotomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vital capacity of the lungs.
Time Frame: One year after surgery.
Vital capacity (VC) measured with spirometry.
One year after surgery.
Forced vital capacity of the lungs.
Time Frame: One year after surgery.
Forced vital capacity (VC) measured with spirometry.
One year after surgery.
Forced expiratory volume of the lungs.
Time Frame: One year after surgery.
Forced expiratory volume in 1 second (FEV1) measured with spirometry.
One year after surgery.
Forced expiratory volume percent of the lungs.
Time Frame: One year after surgery.
Forced expiratory volume in 1 second divided with forced vital capacity, measured with spirometry.
One year after surgery.
Peak expiratory flow of the lungs.
Time Frame: One year after surgery.
Peak expiratory flow measured with spirometry.
One year after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disability
Time Frame: Six months and one year after surgery.
Degree of disability assessed with Disability Rating Index (DRI) scale ranging from 0-100 where higher scores indicate more disability.
Six months and one year after surgery.
Physical activity
Time Frame: Six months and one year after surgery.
Physical activity assessed with Grimby activity scale ranging from 1-6 where 6 indicates the highest level of activity.
Six months and one year after surgery.
Shoulder mobility
Time Frame: Six months and one year after surgery.
Shoulder mobility assessed with Boström index, a scale ranging from 5-30 for each shoulder where 30 represents the greatest range of movement.
Six months and one year after surgery.
Respiratory movement
Time Frame: Six months and one year after surgery.
Movement of chest wall during respiration measured with Respiratory Movement Measuring Instrument (RMMI).
Six months and one year after surgery.
Strength of respiratory muscles
Time Frame: Six months and one year after surgery.
Strength of respiratory muscles measured with Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP).
Six months and one year after surgery.
Quality of life EQ-5D-5L
Time Frame: Six months and one year after surgery.
Quality of life assessed with the EuroQol (European Quality of Life) Five Dimension Five Level Scale (EQ-5D-5L). A 5-dimensional scale in which each dimension has 5 levels where 1 represents the best outcome and 5 represents the worst outcome.
Six months and one year after surgery.
Radiological healing
Time Frame: One year after surgery.
Radiological signs of healing of the participants rib fractures assessed with CT scan. Fractures will be denoted as healed, partially healed or with no signs of healing.
One year after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahlgrenska University Hospital

Investigators

  • Principal Investigator: Erik Westin, MD, Sahlgrenska University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2021

Primary Completion (Actual)

May 5, 2022

Study Completion (Actual)

May 11, 2023

Study Registration Dates

First Submitted

December 18, 2020

First Submitted That Met QC Criteria

January 13, 2021

First Posted (Actual)

January 14, 2021

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FoU-274457

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Sharing data with other researchers will be considered by request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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