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Multicenter RCT of SSRF in Non Flail Patients

NCT03221595 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2021-05-06

Study results available
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Summary

This study evaluates the efficacy of surgical stabilization of rib fractures, as compared to best medical management, for patients with multiple, displaced rib fractures.

Half of patients will be randomized to surgery (in addition to best medical management), whereas the other half will be randomized to medical therapy only.

The primary outcome will be the subjects overall quality of life measured at two months following injury.

Conditions

  • Rib Fracture Multiple

Interventions

DEVICE

Operative

This operation involves reducing and providing rigid fixation of displaced rib fractures with permanent plates or splints

Sponsors & Collaborators

  • DePuy Synthes

    collaborator INDUSTRY

  • Denver Health and Hospital Authority

    lead OTHER

Principal Investigators

  • Fredric M Pieracci, MD MPH · Denver Health Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-02
Primary Completion
2019-10-22
Completion
2020-01-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03221595 on ClinicalTrials.gov