NCT07757594

Brief Summary

Anterior shoulder dislocation is a common orthopedic emergency that requires prompt reduction to relieve pain and restore joint function. Several techniques have been described for closed reduction, but the optimal method remains uncertain. The FARES (Fast, Reliable, and Safe) technique is a relatively new reduction method that may provide faster reduction with less pain compared with the conventional traction-countertraction technique. This randomized controlled trial aims to compare the effectiveness and safety of the FARES technique and the traction-countertraction technique for the reduction of acute anterior shoulder dislocation in adult patients. Eligible participants will be randomly assigned to receive reduction using either the FARES technique or the traction-countertraction technique. The study will evaluate the success rate of reduction, pain experienced during the procedure, time required for reduction, and procedure-related complications. The findings of this study may provide evidence to guide the selection of reduction techniques for patients with acute anterior shoulder dislocation in the emergency department.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Aug 2026Apr 2027

First Submitted

Initial submission to the registry

July 25, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 11, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

August 11, 2026

Status Verified

August 1, 2026

Enrollment Period

8 months

First QC Date

July 25, 2026

Last Update Submit

August 5, 2026

Conditions

Keywords

Anterior shoulder dislocationClosed reductionFARES techniqueTraction-countertraction techniqueEmergency department

Outcome Measures

Primary Outcomes (1)

  • Successful reduction at the first attempt

    Proportion of participants achieving successful reduction using the assigned technique without requiring an alternative reduction method.

    During the initial reduction procedure

Secondary Outcomes (6)

  • Time to successful reduction

    During the reduction procedure

  • Pain intensity during reduction procedure

    Immediately after completion of the reduction procedure

  • Number of reduction attempts

    During the reduction procedure

  • Procedure-related complications

    During the reduction procedure and immediate post-reduction assessment

  • Factors associated with successful reduction

    From baseline assessment until completion of the reduction procedure

  • +1 more secondary outcomes

Study Arms (2)

FARES Technique

EXPERIMENTAL

Participants assigned to this arm will undergo closed reduction of acute anterior shoulder dislocation using the FARES (Fast, Reliable, and Safe) technique.

Procedure: FARES Technique

Traction-Countertraction Technique

ACTIVE COMPARATOR

Participants assigned to this arm will undergo closed reduction of acute anterior shoulder dislocation using the conventional traction-countertraction technique.

Procedure: Traction-Countertraction Technique

Interventions

Closed reduction of acute anterior shoulder dislocation using the FARES (Fast, Reliable, and Safe) technique.

FARES Technique

Closed reduction of acute anterior shoulder dislocation using the conventional traction-countertraction technique.

Traction-Countertraction Technique

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years.
  • Conscious and cooperative patients.
  • Anterior shoulder dislocation confirmed by shoulder radiographs (anteroposterior view and Y-view).
  • Time from injury to reduction \<24 hours.
  • Simple anterior shoulder dislocation or anterior shoulder dislocation associated with greater tuberosity fracture only.
  • Patient agrees to participate in the study and provides informed consent.

You may not qualify if:

  • Other injuries of the same upper extremity.
  • Neurovascular deficits before reduction.
  • Polytrauma, hemodynamic instability, or medical conditions contraindicating immediate reduction.
  • Previous surgery of the affected shoulder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital for Traumatology and Orthopaedics

Ho Chi Minh City, Ho Chi Minh City, 700000, Vietnam

Location

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Ngoc Quyen Le, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This is an open-label study because the reduction technique cannot be masked to participants or investigators.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned in a 1:1 ratio to receive closed reduction using either the FARES technique or the traction-countertraction technique.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 25, 2026

First Posted

August 11, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

August 11, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared with other researchers. The collected data contain clinical information obtained from participants during the study, and sharing individual-level data was not included in the approved study protocol. Only aggregated and anonymized results will be reported in scientific publications.

Locations