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Prospective Follow up of Minimally Invasive Chest Wall Surgery After Trauma

NCT ID: NCT04710602

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-15

Study Completion Date

2023-05-11

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Rib; Fracture, Multiple, With Flail Chest

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Minimally invasive

Patients who underwent surgery with a muscle sparing, minimally invasive technique for unstable chest wall after trauma.

Minimally invasive surgical fixation of unstable rib cage

Intervention Type 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).

Historical control

Patients who underwent surgery with large incisions and simultaneous thoracotomy for unstable chest wall after trauma.

Large incision surgical fixation of unstable rib cage.

Intervention Type 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.

Interventions

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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).

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Erik Öberg Westin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erik Westin, MD

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital

Locations

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Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 26889439 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27307787 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17670487 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25642282 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23415550 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11956391 (View on PubMed)

Westin EO, Olsen MF, Caragounis EC. Comparison of long-term outcome between muscle sparing and non-muscle sparing surgical techniques in rib plating. Eur J Trauma Emerg Surg. 2025 May 20;51(1):212. doi: 10.1007/s00068-025-02881-z.

Reference Type DERIVED
PMID: 40392360 (View on PubMed)

Other Identifiers

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FoU-274457

Identifier Type: -

Identifier Source: org_study_id