Operative Treatment of Ankle Fractures

Not Applicable

Completed

• Conditions: Ankle Fracture, Bimalleolar; Ankle Fracture, Trimalleolar; Ankle Fracture - Lateral Malleolus
• Interventions: Diagnostic Test: Specific provocation test

• Registration Number: NCT04437355
• Lead Sponsor: Spital Limmattal Schlieren

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.

Study Timeline

• Study Start: 2018-07-01
• Study First Submitted: 2020-01-07
• Study First Submitted QC: 2020-06-16
• Study First Posted: 2020-06-18
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ankle Fracture Weber C and complex	Specific provocation test	Young and healthy patients with an operative treated fracture of the ankle (type Weber C or complex fracture)
Control Group	Specific provocation test	Young and healthy Group of People (18-50 years) without any pathology of the lower limb
Ankle Fracture Type Weber B	Specific provocation test	Young and healthy patients with an operative treated fracture of the ankle (type Weber B)

Primary Outcome Measures

Name	Time	Method
Functional outcome	24 months after initial operation	This outcome will be compared with a group of adults matching in terms of gender and age. Measured by: - three questionnaires (quality of life, possible movement, restrictions in daily life etc.)

Secondary Outcome Measures

Name	Time	Method
Clinical outcome 2	24 months after initial operation	- Quality of life questionnaire; Explanation: The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software for the commercial version, but no special software is needed for the RAND-36 version. Pricing depends on the number of scores that the researcher needs to calculate.
Clinical outcome 1	24 months after initial operation	- VAS: Visual analogue score 1-10; Explanation: 1 means almost no pain, 10 is the worst pain one can imagine
Clinical outcome 3	24 months after initial operation	* Arthrosis compared to the non-affected ankle measured by X-Ray (after an ankle fracture followed by an operative Treatment); * The measurement consists of evaluation the joint congruency, quality of the bone and the cartilage and the clear spaces (medial, central, lateral).

Trial Locations

Locations (1)

Spital Limmattal; 🇨🇭 Schlieren, Zurich, Switzerland