Recruiting

Observational Study

Sponsor:

University of Calgary

Code:

NCT05867355

Conditions

Clavicle Fracture

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

surgical fixation

Study Details

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.

Conditions

Clavicle Fracture

Study ID

NCT05867355

Start date

Mar 22, 2021

Status verified date

May, 2023

Completion date

Dec 1, 2025

Anticipated

Primary completion date

Jun 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

111 participants

Anticipated

Interventions and Outcome Measures

Interventions

surgical fixation

compare implant removal rates between surgical fixation techniques.

Primary outcome measure

  • Determine implant removal rates [ Time Frame: 4 years ]
  • Identify rationale for implant removal [ Time Frame: 4 years ]

Central Contacts and Locations

Locations

Foothills Medical Centre

Recruiting

Calgary, Alberta, Canada, T2N 5A1

Contacts

Prism Schneider

403-944-4518prism.schneider@albertahealthservices.ca

Jessica Duong

403-220-3366jduong@ucalgary.ca

More Information

Sponsor

University of Calgary

Last update posted

May 22, 2023

Last verified

May, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2023-05-22.