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NCT Number: NCT04710602

Prospective Follow up of Minimally Invasive Chest Wall Surgery 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.

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Key information

Conditions

Rib; Fracture, Multiple, With Flail Chest Fractures, Bone Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sahlgrenska University Hospital

Gothenburg, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Minimally invasive surgical fixation of unstable rib cage

Procedure

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).

Large incision surgical fixation of unstable rib cage.

Procedure

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.

Primary outcomes

  1. Vital capacity of the lungs.

    Time frame: One year after surgery.

    Vital capacity (VC) measured with spirometry.

  2. Forced vital capacity of the lungs.

    Time frame: One year after surgery.

    Forced vital capacity (VC) measured with spirometry.

  3. Forced expiratory volume of the lungs.

    Time frame: One year after surgery.

    Forced expiratory volume in 1 second (FEV1) measured with spirometry.

  4. 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.

  5. Peak expiratory flow of the lungs.

    Time frame: One year after surgery.

    Peak expiratory flow measured with spirometry.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Respiratory movement

    Time frame: Six months and one year after surgery.

    Movement of chest wall during respiration measured with Respiratory Movement Measuring Instrument (RMMI).

  5. 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).

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jan 14, 2021
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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