Operative Treatment of Ankle Fractures

Spital Limmattal Schlieren

Status: Completed

Conditions: Ankle Fracture - Lateral Malleolus; Ankle Fracture, Trimalleolar; Ankle Fracture, Bimalleolar

Treatments: Diagnostic Test: Specific provocation test

Study type: Interventional

Funder types: Other

Identifiers

NCT04437355

2018-01124

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Control Group

Active Comparator group

Description:

Young and healthy Group of People (18-50 years) without any pathology of the lower limb

Treatment:

Diagnostic Test: Specific provocation test

Ankle Fracture Type Weber B

Active Comparator group

Description:

Young and healthy patients with an operative treated fracture of the ankle (type Weber B)

Treatment:

Diagnostic Test: Specific provocation test

Ankle Fracture Weber C and complex

Active Comparator group

Description:

Young and healthy patients with an operative treated fracture of the ankle (type Weber C or complex fracture)

Treatment:

Diagnostic Test: Specific provocation test