Displaced midshaft fractures of the clavicle: non-operative treatment versus plate fixation (Sleutel-TRIAL). A multicentre randomised controlled trial
2011

Comparing Non-Operative Treatment and Plate Fixation for Clavicle Fractures

Sample size: 350 publication Evidence: high

Author Information

Author(s): Stegeman Sylvia A, de Jong Mireille, Sier Cornelis FM, Krijnen Pieta, Duijff Jan W, van Thiel Tom PH, de Rijcke Piet AR, Soesman Nicolaj MR, Hagenaars Tjebbe, Boekhoudt Freek D, de Vries Mark R, Roukema Gert R, Tanka Andras FK, van den Bremer Jephta, van der Meulen Hub GWM, Bronkhorst Maarten WGA, van Dijkman Bart A, van Zutphen Stephan WAM, Vos Dagmar I, Schep Niels WL, Eversdijk Martin G, van Olden Ger DJ, van den Brand Johan GH, Hillen Robert Jan, Frölke Jan Paul M, Schipper Inger B

Primary Institution: Leiden University Medical Centre

Hypothesis

Is plate fixation more effective than non-operative treatment for dislocated midshaft clavicular fractures?

Conclusion

The study aims to determine whether plate fixation leads to better healing and shoulder function compared to non-operative treatment.

Supporting Evidence

  • Fractures of the clavicle account for 2.6 to 4 percent of all adult fractures.
  • Midshaft fractures account for 69 to 82 percent of all clavicular fractures.
  • Recent studies reported a non-union rate up to 15 percent and more.
  • Two-thirds of midshaft clavicular fractures may have some degree of mal-union.
  • Operative treatment is increasingly accepted as primary treatment for dislocated midshaft clavicular fractures.

Takeaway

This study is like a big test to see if fixing a broken collarbone with a plate is better than just using a sling.

Methodology

A multicentre randomised controlled trial comparing non-operative treatment with a sling and plate fixation in 350 patients with dislocated midshaft clavicular fractures.

Potential Biases

Potential bias due to selective loss to follow-up, particularly in the non-operative group.

Limitations

The study may face challenges such as loss to follow-up and variability in treatment preferences among surgeons.

Participant Demographics

Patients aged 18 to 60 years, with a majority being male.

Statistical Information

P-Value

p<0.05

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1186/1471-2474-12-196

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