A Study to Evaluate Operative versus Non-operative Intervention of Posterior Malleolar Fractures Involving Less than 25% of the Articular Surface

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 19-002706
    Sponsor Protocol Number: 19-002706

About this study

The purpose of this study is determine if posterior malleolar fractures involving less than 25% of the articular surface should undergo operative intervention to improve clinical outcomes.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • > 18 years old.
  • AO classification Type 44 A, B, C.
  • posterior malleolus fragment measuring < 25% of the maximal A-P diameter of the tibial plafond as measured on pre-operative CT.

Exclusion Criteria: 

  • Previous surgery about the ankle.
  • Non-ambulatory status preoperatively.
  • Ipsilateral lower extremity injury which would be expected to affect mobility status’.
  • Contraindication to prone positioning during surgery.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Brandon Yuan, M.D.

Contact us for the latest status

Contact information:

Aaron Owen M.D.

Owen.Aaron@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20463657

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