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NCT Number: NCT00872105

Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle

This is a multicentre randomized clinical trial prospectively comparing operative treatment versus conservative (nonoperative) care in the management of displaced distal (Type II) clavicle fractures.

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Key information

Conditions

Clavicle Fracture Fractures Fractures, Bone Wounds and Injuries

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Michael's Hospital

Toronto, Ontario, M5C 1R6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men or women aged 16 to 60 years of age
  • Completely displaced (no cortical contact), closed fracture of the distal 3rd of the clavicle (Type II) confirmed by radiograph
  • Fractures within 28 days post injury
  • Provision of informed consent

Exclusion criteria

  • Pathological fractures
  • Non-displaced (cortical contact) distal clavicle fractures
  • Open clavicle fractures
  • Presence of vascular injury
  • Fractures more than 28 days post-injury
  • Limited life expectancy due to significant medical co-morbidity
  • Medical contraindication to surgery
  • Inability to comply with rehabilitation or form completion
  • Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, patients not mentally competent to give consent, etc.)

Treatment and study plan

Non-operative treatment

Procedure

Standard protocol for conservative treatment will consist of the implementation of a sling, for clavicular support and patient comfort. Pendulum or gentle Range of Motion (ROM) shoulder exercises may be implemented at any time as dictated by the attending surgeon.

Operative treatment

Procedure

The operating surgeon will determine the positioning of the patient for surgery. ORIF of the distal clavicle fracture will be carried out as follows:

Anatomic reduction of the fracture Definitive fixation with a contoured clavicle plate and screws; a AO hook plate; a 3.5 LCDC, reconstruction, or compression plate is acceptable; a 1/3 tubular plate is not acceptable Use of bone graft is optional (iliac crest bone autograft)

Primary outcomes

  1. The primary outcome measurement will be patient DASH (Disabilities of the Arm, Shoulder and Hand Instrument) scores. The DASH is a patient-oriented, limb-specific, functional measurement questionnaire.

    Time frame: 2 years

Secondary outcomes

  1. The secondary outcome measurement patients' functional shoulder scores as defined by Constant's Shoulder Score (i.e. pain, activities of daily living, range of motion and power).

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Collaborators

  • Fraser Health
  • London Health Sciences Centre
  • McGill University Health Centre/Research Institute of the McGill University Health Centre
  • Nova Scotia Health Authority
  • The Ottawa Hospital
  • University of British Columbia
  • University of Calgary
  • Winnipeg Regional Health Authority

Registry information

Official study title

A Multicentre, Randomized Trial of Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle

Important dates

Study start
2009
Primary completion
2018
Study completion
2019
First posted
Mar 31, 2009
Registry last updated
Nov 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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