NCT04710602

Prospective Follow up of Minimally Invasive Chest Wall Surgery After Trauma

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Sahlgrenska University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Rib; Fracture, Multiple, With Flail Chest

Interventions

Type	Name	Description
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).
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.

Timeline

• Start date: 2021-01-15
• Primary completion: 2022-05-05
• Completion: 2023-05-11
• First posted: 2021-01-14
• Last updated: 2023-11-29

Locations

1 site across 1 country: Sweden