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Completed

NCT Number: NCT03415958

A Prospective Cohort of Displaced Adolescent Midshaft Clavicle Fractures

Outcomes for displaced midshaft clavicle fractures in adolescents are not defined. The current method of treatment for these fractures is non-operative management. There is recent Level 1 evidence in the adult literature to suggest that outcomes are superior when these fractures are managed surgically with open reduction and internal fixation.

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Key information

Conditions

Malunion of Fracture of Clavicle Delayed Union of Fracture of Clavicle Fractures, Bone Wounds and Injuries

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

McGill University Health Centre

Montreal, Quebec, H3G 1A4, Canada

About this study

The study is a prospective observational cohort design of the natural history of adolescent clavicle fractures treated at the McGill University Health Centre. Surgeon choice will dictate treatment. There is no difference from the current normal therapy choice of each individual surgeon. Patients will be offered either operative or conservative management.

Operative Treatment: Patients with displaced midshaft clavicle fractures will be offered operative treatment which involves open reduction and internal fixation with a plate. This is the standard treatment for completely displaced fractures in the adult population at our Institution based on Level 1 evidence.

Conservative care: Patients will be treated in a sling for the acute phase of two weeks with progressive physiotherapy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 12-18 years old
  • The only fracture present in that upper extremity
  • Individual and/or parents able to comply with follow-up

Exclusion criteria

  • Head injury
  • Prior injury, degenerative condition or congenital condition of the upper extremities
  • Systemic disease that may impair healing
  • Incapable of ensuring follow-up

Treatment and study plan

Primary outcomes

  1. Malunion and/or non-union in this cohort

    Time frame: 3 months

    Radiographic evaluation

Secondary outcomes

  1. Times to union (clinical and radiographic) following fracture

    Time frame: 3 months

    Radiologic evaluation

Other outcomes

  1. Visual Analogue Scale

    Time frame: 6 weeks, 3 months, 6 months, 12 months

    a measurement instrument for subjective characteristics which cannot be directly measured

  2. Constant Shoulder Score

    Time frame: 6 weeks, 3 months, 6 months, 12 months

    a measurement instrument for strength, range of motion, power

  3. Disabilities of the Arm, Shoulder and Hand

    Time frame: 6 weeks, 3 months, 6 months, 12 months

    a questionnaire

  4. Activities & Your Injury

    Time frame: 6 weeks, 3 months, 6 months, 12 months

    a questionnaire

Sponsors and collaborators

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Other

Registry information

Official study title

A Prospective Cohort of Displaced Adolescent Midshaft Clavicle Fractures: Are Times to Return to Activities and Functional Outcomes Reasonable for This Population?

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Jan 30, 2018
Registry last updated
Jan 30, 2018

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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