Clinical trial NCT04163224: Minimal Invasive Approach for Surgical Repair of Rib Fractures With a Novel Intrathoracic Device
Official title: Minimal Invasive Approach for Surgical Repair of Rib Fractures With a Novel Intrathoracic Device. Case Series
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Rib Fracture Multiple
Keywords: multiple rib fractures
chest stabilization
rib plates
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2019-11-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated for rib fracture repair using RibFix Advantage System alone or in combination with other methods for rib fracture repair

Brief summary: A retrospective review of demographics and adverse events from cases completed with the RibFix Advantage System. Evaluation of device integrity, and performance by a prospective CT scan with a minimum of 3 months post-implantation.

Detailed description: The RibFix Advantage System is a novel intrathoracic titanium plating system that is FDA-cleared for the treatment of rib fractures. The RibFix Advantage System is designed to be implanted in a less invasive procedure where plates are introduced and placed on the pleural cortex of the rib during video-assisted thoracoscopic surgery. Intrathoracic plate placement allows for smaller cutaneous incisions and less muscle disruption, which may aid in patient recovery compared to traditional open reduction internal fixation systems that are currently available.

The purpose of this study is to gather the first clinical data on this novel device in the context of a case series of patients with radiologic and quality-of-life follow-up.

Eligibility criteria: Inclusion Criteria:

* Male or Female
* ≥ 18 years old (no upper limit)
* Underwent surgical repair of rib fracture(s) with the RibFix Advantage System alone or in combination with other systems for fracture repair
* Signed Informed Consent Form for participation in a clinical trial
* Willing and able to return for a follow-up visit (includes a computed tomography (CT) scan of the chest)

Exclusion Criteria:

* Off label use of RibFix Advantage (e.g., active or latent infection at the time of implantation, sepsis, metal sensitivity)

Primary outcomes:
measure: Fracture stability
timeFrame: 3 months post-implantation
measure: Device integrity
timeFrame: 3 months post-implantation
Secondary outcomes:
measure: Adverse Events of Interest
timeFrame: From the the date of implantation until the day of hospital discharge, or up to 10 days post-implantation, whichever occurs first; 30 days post surgery; 3 month post-implantation
Other outcomes:
Locations:
Study officials:
affiliation: Zimmer Biomet
name: Mark Sun
role: STUDY_DIRECTOR
References:
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