Operative Treatment of Ankle Fractures

  • STATUS
    Recruiting
  • participants needed
    90
  • sponsor
    Spital Limmattal Schlieren
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Updated on 16 February 2024
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Summary

Patients who underwent operative treatment of an ankle fracture with or without following removal of the osteosynthetic material are examined by a specific ankle provocation test, a questionnaire and X-Rays to evaluate the clinical, functional and radiological outcome compared to a healthy control group

Description

The study includes all patients operated from 09.12.2012 to 31.12.2020. Patients will undergo an X-Ray at least two years after primary surgery or at least one year after removal of the osteosynthetic material. The patients operated from 09.12.2012 to date are therefore a retrospective cohort, the patients from to date until 31.12.2020 a prospective cohort. This method is used to achieve the highest possible number of patients in a define period of time with no alteration of surgical technique.

All patients in the retrospective cohort are contacted at least 2 years after surgery (or 1 year after removal) via phone call or letter, informed about the study and asked to participate. In case of informed consent, they are invited to the study site. They are asked to complete the questionnaires and they undergo X-Ray of the affected and the non-affected ankle.

All patients in the prospective cohort are informed about the study and asked to participate in the outpatient clinic. In case of informed consent, they are invited to the study site at least 2 years after surgery. They are asked to complete the questionnaires and they undergo na X-Ray of the affected and non-affected ankle.

Details
Condition Ankle Fracture, Trimalleolar, Ankle Fracture - Lateral Malleolus, Ankle Fracture, Bimalleolar
Age 18years - 50years
Treatment Specific provocation test
Clinical Study IdentifierNCT04437355
SponsorSpital Limmattal Schlieren
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Age older than 18 and younger than 51 years
Operative treatment of an ankle fracture
Time operation to follow up: at least 2 years
Time removal of osteosynthetic material to follow up: at least 1 year
Time operative treatment to removal of the osteosynthetic material: at least 9 months
Informed Consent as documented by signature (Appendix: Informed Consent Form)

Exclusion Criteria

Other pathologies of the lower limb of the affected and/or non-affected side (fractures, pre-existing arthrosis or operative treatment of the affected and/or non-affected limb)
Pre-existing vascular (peripheral arterial disease, diabetes) or neurological diseases of the lower extremities
Women who are pregnant
Prevalence of an infection of the implanted osteosynthetic material
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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