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OpenTrials
Completed

NCT Number: NCT00642265

The Treatment of Clavicular Fractures

Patients with a displaced, shortened, midshaft clavicular fracture are randomized in two groups: conservative or operative treatment. The conservative arm is treated with a sling for 6 weeks. The operative arm is treated with osteosynthesis, within 2 weeks.

Patients are clinically and radiologically evaluated during 1 year. A economical analysis is also done.

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Key information

Conditions

Displaced, Midshaft Clavicular Fractures

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stedelijk Ziekenhuis Aalst, Aalst, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 to 65 year
  • 100% displaced midshaft clavicular fracture
  • shortening
  • male: 18mm
  • female: 14mm

Exclusion criteria

  • pregnancy
  • pathological fracture
  • open fracture
  • history of frozen shoulder
  • ipsilateral fracture of shoulder or scapula
  • neurovascular injury
  • contraindication to anaesthesia

Treatment and study plan

Osteosynthesis

Procedure

operative treatment

sling

Other

conservative treatment

Primary outcomes

  1. Union

    Time frame: 1 year

  2. Functionality

    Time frame: 1 year

Secondary outcomes

  1. Complications

    Time frame: 1 year

  2. Time to heal

    Time frame: 1 year

  3. Cost

    Time frame: 1 year

  4. Relation with medication

    Time frame: 1 year

  5. Relation with smoking

    Time frame: 1 year

  6. Relation with job

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • AZ Sint-Jan AV

Registry information

Official study title

The Treatment of Displaced, Midshaft Clavicular Fractures: Operative vs Conservative. A Prospected, Randomized Study

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 25, 2008
Registry last updated
Jan 4, 2023

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.