Ankle Trauma: an Emergency Nurse Assessment Study

NCT04126837 | Completed DMC

• 1 other identifier: 38RC19.200
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The ankle and/or foot injuries incidence is high. Lateral ankle sprains are most common diagnosis, while fractures represent less than 15% of final diagnosis. Ankle and/or foot injuries are associated with significant morbidity in terms of pain and chronic instability. The societal cost of these injuries is significant mainly related to hospital care and sick-leave. In summary ankle and/or foot injuries are very frequent reason for emergency admission. The study hypothesis is that an accelerated nursing care system for traumatized ankle and/or foot patients is feasible and allows patients to be cared for in accordance to current medical recommendations. Such a branch should be followed by a return to work and sports within a time frame consistent with the literature. The duration of patient management in emergency department should be short, less than that observed in a historical cohort. Finally patient satisfaction should be high. In the medium term, the implementation of an accelerated nursing branch for the diagnosis and treatment of ankle and/or foot injuries should contribute to effective care and reduction of over activity in emergency departments.

Conditions

Ankle Injuries; Foot Injuries; Diagnosis; Treatment

Keywords

Ankle; Foot; Injuries; Ottawa Rules; nurse

Outcome Measures

Primary Outcomes (1)

• Percentage of patients who have received a diagnosis and treatment in accordance with medical recommendations.

  Percentage of patients who have received a diagnosis and treatment by nurse in accordance with medical recommandation

  30 days

Secondary Outcomes (7)

• Percentage of patients with diagnosis in accordance with Ottawa rules

  1 day

• Description of pain intensity

  1 day

• Deadline for return to work and /or sports

  30 days

• Consummation of care (excluding medicines)

  30 days

• Evaluate the time required to manage patients

  30 days

Study Arms (1)

Patient admitted for Ankle and foot injuries

OTHER

Diagnosis and treatment of Ankle and foot injuries by an accelerated nursing branch in emergency department

Other: Diagnosis and treatment

Interventions

Diagnosis and treatment OTHER

Monocentric, Prospective and Biomedical Research excluding Health Product

Also known as: Assessment of an accelerated nursing branch for the diagnosis and treatment of ankle and/or foot injuries in emergency department.

Patient admitted for Ankle and foot injuries

Eligibility Criteria

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

You may qualify if:

• Isolated Ankle and/or foot Trauma out of dermabrasion
• Admission to emergency department \< 48 hours after the trauma
• Written informed consent must be obtained
• For women of childbearing age: effective contraception in place for at least 3 months

You may not qualify if:

• X-ray performed before patient admission
• Obvious open fracture
• Ankle fracture or obvious deformation
• Suspicion of polytrauma
• Anterior surgery of the ankle and/or foot
• Excessive alcoholization or intoxication by other psychoactive substances
• Persons unable to communicate in french, with impaired comprehension skills and consciousness (problem with mental health)
• Adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of liberty
• Non-affiliated to the french social security system (or equivalent)
• Pregnant or nursing women
• Patient participating in any interventional clinical reserach study

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Grenoble Alpes University Hospital

Grenoble, Isere, 38043, France

Location

MeSH Terms

Conditions

Ankle Injuries; Foot Injuries; Disease; Wounds and Injuries

Interventions

Therapeutics; Emergency Service, Hospital

Condition Hierarchy (Ancestors)

Leg Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hospital Departments; Hospital Administration; Health Facility Administration; Health Facilities; Health Care Facilities Workforce and Services; Emergency Medical Services; Health Services; Organization and Administration; Health Services Administration

Study Officials

• Damien VIGLINO, MD,PhD

  Emergency Department of University Hospital Grenoble

  PRINCIPAL INVESTIGATOR

• Nicolas TERMOZ MASSON, Bachelor

  Emergency Department of University Hospital Grenoble

  STUDY DIRECTOR

• Alexandra BICHET, Bachelor

  Emergency Department of University Hospital Grenoble

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 15, 2019
• Study Start: March 5, 2020
• Primary Completion: March 5, 2024
• Study Completion: April 5, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: at the time of publication
• Access Criteria: The international writing and publication rules (The Uniform Requirements for Manuscripts of the ICMJE, April 2010) will be followed. And In accordance with the French law n ° 2002-303 of March 4th, 2002

Locations

FR (1)