Multicenter RCT of SSRF in Non Flail Patients

NCT03221595 | Completed Results DMC FDA Device

• 1 other identifier: COMIRB 17-1432
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Numeric Pain Score

  Patient self-reported pain score on an 11 point scale scale ranging from 0-10; 0 being "no pain" to 10 "the worst pain imaginable".

  Hospital days 1-7, day of discharge (an average of 1 week) and at 2, 4 and 8 weeks following discharge from hospital.

Secondary Outcomes (7)

• Length of Stay

  2 months after injury

• Daily Narcotic Use

  Inpatient: occurred daily at 10 AM while the patient was hospitalized. Post-discharge: occurred at outpatient clinic follow-up encounter that occurred at 2, 4, and 8 weeks post discharge.

• Incentive Spirometry

  Inpatient: occurred daily at 10 AM while the patient was hospitalized. Post-discharge: occurred at outpatient clinic follow-up encounter that occurred at 2, 4, and 8 weeks post discharge.

• Pulmonary Function Testing

  once, at first follow-up, outpatient, clinic visit, which occurred at 2 weeks post discharge.

• Number of Patients With Pneumonia

  Study participants were followed up to 2 months after index admission date.

Study Arms (2)

Operative

EXPERIMENTAL

Patients in the operative arm will undergo best medical management, in addition to surgical stabilization of their displaced rib fractures within 72 hours of admission to the hospital.

Device: Operative

Non-operative

NO INTERVENTION

Patients in the non operative arm will undergo best medical management of their displaced rib fractures.

Interventions

Operative DEVICE

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

Also known as: Surgical stabilization of rib fractures, rib plating

Operative

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalization with ≥ 3 severely displaced (≥ 50% of rib width) acute rib fractures.
• Two or more of the following pulmonary physiologic derangements (at the time of consideration for enrollment and after best medical therapy).
• Respiratory rate \> 20 breaths per minute
• Incentive spirometry \< 50% predicted (appendix D)
• Numeric pain score \> 5
• Poor cough (as documented by respiratory therapist)
• Surgery anticipated \< 72 hours from injury

You may not qualify if:

• Age \< 18 years or ≥ 80 years
• Flail chest: either radiographic or clinical. Radiographic flail chest is defined on CT chest as ≥ 2 ribs each fractured in ≥ 2 places. Clinical flail is defined as visualization of a segment of chest wall with paradoxical motion on physical exam.
• Moderate or severe traumatic brain injury (GCS at the time of consideration for enrollment \< 12)
• Intubation
• Severe pulmonary contusion, defined as Blunt Pulmonary Contusion 18 (BPC18) score \> 12 \[19\].
• Prior or expected emergency exploratory laparotomy during this admission.
• Prior or expected emergency thoracotomy during this admission.
• Prior or expected emergency craniotomy during this admission.
• Spinal cord injury
• Pelvic fracture that has required, or is expected to require, operative intervention during this admission.
• The patient was unable to accomplish activities of daily living independently prior to injury (e.g., dressing, bathing, prepearing meals).
• Pregnancy.
• Incarceration.

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead
• DePuy Synthes: collaborator

Study Sites (1)

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

Related Publications (1)

• Pieracci FM, Majercik S, Ali-Osman F, Ang D, Doben A, Edwards JG, French B, Gasparri M, Marasco S, Minshall C, Sarani B, Tisol W, VanBoerum DH, White TW. Consensus statement: Surgical stabilization of rib fractures rib fracture colloquium clinical practice guidelines. Injury. 2017 Feb;48(2):307-321. doi: 10.1016/j.injury.2016.11.026. Epub 2016 Nov 27. No abstract available.

  PMID: 27912931 BACKGROUND

Results Point of Contact

• Title: Research Coordinator
• Organization: Denver Health Medical Center

Kiara.Leasia@dhha.org

303-602-6213

Study Officials

• Fredric M Pieracci, MD MPH

  Denver Health Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, controlled trial

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: July 18, 2017
• Study Start: January 2, 2018
• Primary Completion: October 22, 2019
• Study Completion: January 1, 2020
• Last Updated: May 6, 2021
• Results First Posted: April 5, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)