NCT05867355

Brief Summary

This prospective, multi-centre study aims to determine clinical, radiographic, and patient-reported outcomes (PROMs) following surgical fixation of displaced mid-diaphyseal clavicle fractures and to compare implant removal rates between techniques within 2-years of the procedure.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
111

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 22, 2021

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 22, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 22, 2023

Status Verified

May 1, 2023

Enrollment Period

4.2 years

First QC Date

May 4, 2023

Last Update Submit

May 19, 2023

Conditions

Clavicle Fracture

Outcome Measures

Primary Outcomes (2)

  • Determine implant removal rates

    To report implant removal rates in an appropriately powered prospective cohort study.

    4 years

  • Identify rationale for implant removal

    To report rationale for implant removal in an appropriately powered prospective cohort study.

    4 years

Interventions

surgical fixationPROCEDURE

compare implant removal rates between surgical fixation techniques.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Skeletally mature, adult participants aged 18 years of age or older, who are treated with surgical fixation for a displaced mid-diaphyseal clavicle fracture. Exclusion criteria: Pathological fractures, clavicle non-unions, current or prior ipsilateral upper extremity injury that may impact functional outcomes, or an inability to consent or complete follow-up.

You may qualify if:

  • Treated with surgical fixation for a displace mid-diaphyseal clavicle fracture.
  • Aged 18 years of age or older and skeletally mature.
  • Enrolled within 21 (+3 days) of injury.
  • Willing and able to complete consent and study participation.

You may not qualify if:

  • Pathological fractures.
  • Clavicle non-unions.
  • Current or prior ipsilateral upper extremity injury that may impact functional outcomes.
  • Polytrauma patients with injuries projected to affect rehabilitation course.
  • Active malignancy.
  • Inability to provide consent or complete follow-up.
  • Incarcerated patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foothills Medical Centre

Calgary, Alberta, T2N 5A1, Canada

RECRUITING

MeSH Terms

Interventions

Surgical Fixation Devices

Intervention Hierarchy (Ancestors)

Surgical EquipmentEquipment and Supplies

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopedic Trauma Research Lead

Study Record Dates

First Submitted

May 4, 2023

First Posted

May 22, 2023

Study Start

March 22, 2021

Primary Completion

June 1, 2025

Study Completion

December 1, 2025

Last Updated

May 22, 2023

Record last verified: 2023-05

Locations

CA(1)