Prospective Follow up of Minimally Invasive Chest Wall Surgery After Trauma

Rib; Fracture, Multiple, With Flail Chest Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04710602
• Other study ID #: FoU-274457
• Status: Completed
• Start date: January 15, 2021
• Est. completion date: May 11, 2023

Study information

• Verified date: November 2023
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 11, 2023
• Est. primary completion date: May 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Flail Chest
• Rib; Fracture, Multiple, With Flail Chest

Intervention

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).
• 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.

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (6)

Bemelman M, van Baal M, Yuan JZ, Leenen L. The Role of Minimally Invasive Plate Osteosynthesis in Rib Fixation: A Review. Korean J Thorac Cardiovasc Surg. 2016 Feb;49(1):1-8. doi: 10.5090/kjtcs.2016.49.1.1. Epub 2016 Feb 5. — View Citation

Caragounis EC, Fagevik Olsen M, Pazooki D, Granhed H. Surgical treatment of multiple rib fractures and flail chest in trauma: a one-year follow-up study. World J Emerg Surg. 2016 Jun 14;11:27. doi: 10.1186/s13017-016-0085-2. eCollection 2016. — View Citation

Granetzny A, Abd El-Aal M, Emam E, Shalaby A, Boseila A. Surgical versus conservative treatment of flail chest. Evaluation of the pulmonary status. Interact Cardiovasc Thorac Surg. 2005 Dec;4(6):583-7. doi: 10.1510/icvts.2005.111807. Epub 2005 Sep 15. — View Citation

Granhed HP, Pazooki D. A feasibility study of 60 consecutive patients operated for unstable thoracic cage. J Trauma Manag Outcomes. 2014 Dec 30;8(1):20. doi: 10.1186/s13032-014-0020-z. eCollection 2014. — View Citation

Marasco SF, Davies AR, Cooper J, Varma D, Bennett V, Nevill R, Lee G, Bailey M, Fitzgerald M. Prospective randomized controlled trial of operative rib fixation in traumatic flail chest. J Am Coll Surg. 2013 May;216(5):924-32. doi: 10.1016/j.jamcollsurg.2012.12.024. Epub 2013 Feb 13. — View Citation

Tanaka H, Yukioka T, Yamaguti Y, Shimizu S, Goto H, Matsuda H, Shimazaki S. Surgical stabilization of internal pneumatic stabilization? A prospective randomized study of management of severe flail chest patients. J Trauma. 2002 Apr;52(4):727-32; discussion 732. doi: 10.1097/00005373-200204000-00020. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vital capacity of the lungs.	Vital capacity (VC) measured with spirometry.	One year after surgery.
Primary	Forced vital capacity of the lungs.	Forced vital capacity (VC) measured with spirometry.	One year after surgery.
Primary	Forced expiratory volume of the lungs.	Forced expiratory volume in 1 second (FEV1) measured with spirometry.	One year after surgery.
Primary	Forced expiratory volume percent of the lungs.	Forced expiratory volume in 1 second divided with forced vital capacity, measured with spirometry.	One year after surgery.
Primary	Peak expiratory flow of the lungs.	Peak expiratory flow measured with spirometry.	One year after surgery.
Secondary	Disability	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.
Secondary	Physical activity	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.
Secondary	Shoulder mobility	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.
Secondary	Respiratory movement	Movement of chest wall during respiration measured with Respiratory Movement Measuring Instrument (RMMI).	Six months and one year after surgery.
Secondary	Strength of respiratory muscles	Strength of respiratory muscles measured with Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP).	Six months and one year after surgery.
Secondary	Quality of life EQ-5D-5L	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.
Secondary	Radiological healing	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.