Clinical trial NCT04437355: Operative Treatment of Ankle Fractures
Official title: Clinical, Functional and Radiological Outcome After Osteosynthesis of Ankle Fractures Using a Specific Provocation Test- a Combined Retro- and Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Fracture, Trimalleolar
Ankle Fracture - Lateral Malleolus
Ankle Fracture, Bimalleolar
Lead sponsor: Spital Limmattal Schlieren
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional outcome
timeFrame: at least two year after surgery or one year after removal of the osteosynthetic material
measure: Functional outcome
timeFrame: 24 months after initial operation
Secondary outcomes:
measure: Clinical outcome 1
timeFrame: 24 months after initial operation
measure: Clinical outcome 2
timeFrame: 24 months after initial operation
measure: Clinical outcome 3
timeFrame: 24 months after initial operation
Other outcomes:
measure: Specific ankle provocation test
timeFrame: 24 months after initial operation
Locations:
city: Schlieren
country: Switzerland
facility: Spital Limmattal
state: Zurich
Study officials:
affiliation: Spital Limmattal Schlieren
name: Urs Zingg
role: STUDY_CHAIR
References: