Ankle Fracture - Lateral Malleolus Clinical Trial
Official title:
Clinical, Functional and Radiological Outcome After Osteosynthesis of Ankle Fractures Using a Specific Provocation Test- a Combined Retro- and Prospective Study
Verified date | October 2022 |
Source | Spital Limmattal Schlieren |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 90 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Spital Limmattal | Schlieren | Zurich |
Lead Sponsor | Collaborator |
---|---|
Spital Limmattal Schlieren |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Specific ankle provocation test | specific provocation test in our department of physiotherapy supervised by a physiotherapist and one of the investigators. measure of weight bearing, jump on one feet, balance. | 24 months after initial operation | |
Primary | Functional outcome | This outcome will be compared with a group of adults matching in terms of gender and age. Measured by:
- a specific ankle provocation test: Multiple sport test measuring possible movement of the ankle and tolerating stress simulating in sportive movement such as weight bearing, leg press tests etc. The specific provocation test does not have a specific name, because it is self made. |
at least two year after surgery or one year after removal of the osteosynthetic material | |
Primary | Functional outcome | 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.) |
24 months after initial operation | |
Secondary | Clinical outcome 1 | - VAS: Visual analogue score 1-10
Explanation: 1 means almost no pain, 10 is the worst pain one can imagine |
24 months after initial operation | |
Secondary | Clinical outcome 2 | - 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. |
24 months after initial operation | |
Secondary | Clinical outcome 3 | 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). |
24 months after initial operation |
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