Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT05231343

Comparing Dual Mini-fragment Plating to Single Precontoured Plating of Acute Midshaft Clavicle Fractures Trial

Led by Sunnybrook Health Sciences Centre · Updated on 2023-05-24

66

Participants Needed

1

Research Sites

299 weeks

Total Duration

On this page

Sponsors

S

Sunnybrook Health Sciences Centre

Lead Sponsor

C

Canadian Orthopaedic Trauma Society

Collaborating Sponsor

AI-Summary

What this Trial Is About

The rate of surgical fixation of fractures of the collarbone (i.e., midshaft clavicle) has exponentially increased in recent years; however, the rate of repeat procedures for removal of these implants (i.e., plates) due to irritation remains high. Despite technological advances in implant design, nearly one in four patients with a surgically fixed collarbone ultimately undergoes removal of their implant. More recently, there has been a growing body of literature demonstrating the effectiveness of using two smaller caliber plates, which have been found to have similar rates of implant removal. As such, the proposed randomized clinical trial seeks to be the first level I study to directly compare dual mini-fragment plating of acute displaced midshaft clavicle fractures to single precontoured plating. The investigators hypothesize that dual mini-fragment plating will result in lower rates of reoperation with similar rates of union and complication.

CONDITIONS

Official Title

Comparing Dual Mini-fragment Plating to Single Precontoured Plating of Acute Midshaft Clavicle Fractures Trial

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Between 18 and 65 years of age
  • Completely displaced midshaft clavicle fracture with no cortical contact between main proximal and distal fragments (AO/OTA 15.2A/B/C)
  • Fracture suitable for plate fixation with at least three screws in both proximal and distal fragments
Not Eligible

You will not qualify if you...

  • Open fracture
  • Pathological fracture
  • Fracture seen more than 28 days after injury
  • Associated neurovascular injury
  • Associated head injury with Glasgow Coma Scale less than 12
  • Concomitant fracture of the same-side upper extremity
  • Significant medical comorbidities (ASA grade IV and V)
  • Inability to comply with follow-up
  • Lack of consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N 3M5

Actively Recruiting

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Research Team

S

Sara Aman, BSc

CONTACT

K

Katrine Milner, BSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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