Operative Treatment of Ankle Fractures
Primary Purpose
Ankle Fracture, Trimalleolar, Ankle Fracture - Lateral Malleolus, Ankle Fracture, Bimalleolar
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Specific provocation test
Sponsored by
About this trial
This is an interventional diagnostic trial for Ankle Fracture, Trimalleolar
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
Sites / Locations
- Spital Limmattal
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Control Group
Ankle Fracture Type Weber B
Ankle Fracture Weber C and complex
Arm Description
Young and healthy Group of People (18-50 years) without any pathology of the lower limb
Young and healthy patients with an operative treated fracture of the ankle (type Weber B)
Young and healthy patients with an operative treated fracture of the ankle (type Weber C or complex fracture)
Outcomes
Primary Outcome Measures
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.
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.)
Secondary Outcome Measures
Clinical outcome 1
- VAS: Visual analogue score 1-10
Explanation: 1 means almost no pain, 10 is the worst pain one can imagine
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.
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).
Full Information
NCT ID
NCT04437355
First Posted
January 7, 2020
Last Updated
October 25, 2022
Sponsor
Spital Limmattal Schlieren
1. Study Identification
Unique Protocol Identification Number
NCT04437355
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spital Limmattal Schlieren
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Fracture, Trimalleolar, Ankle Fracture - Lateral Malleolus, Ankle Fracture, Bimalleolar
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Young and healthy Group of People (18-50 years) without any pathology of the lower limb
Arm Title
Ankle Fracture Type Weber B
Arm Type
Active Comparator
Arm Description
Young and healthy patients with an operative treated fracture of the ankle (type Weber B)
Arm Title
Ankle Fracture Weber C and complex
Arm Type
Active Comparator
Arm Description
Young and healthy patients with an operative treated fracture of the ankle (type Weber C or complex fracture)
Intervention Type
Diagnostic Test
Intervention Name(s)
Specific provocation test
Intervention Description
To compare the results the investigators invite a healthy control group matching in age and gender with the intervention cohort. The control group is informed about the study and asked to participate in the outpatient clinic. In case of informed consent, the participants are invited to the study site. The participants undergo the same provocation test of the ankle, and are asked to complete the specific provocation test. In case of substantial underachievement in the provocation test (<60% of maximum) an X-Ray of both ankles in a.p. and lateral projection is performed. The aim is to radiologically analyse the ankles, and to rule out any morphological reasons for the above mentioned underperformance.
Primary Outcome Measure Information:
Title
Functional outcome
Description
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.
Time Frame
at least two year after surgery or one year after removal of the osteosynthetic material
Title
Functional outcome
Description
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.)
Time Frame
24 months after initial operation
Secondary Outcome Measure Information:
Title
Clinical outcome 1
Description
- VAS: Visual analogue score 1-10
Explanation: 1 means almost no pain, 10 is the worst pain one can imagine
Time Frame
24 months after initial operation
Title
Clinical outcome 2
Description
- 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.
Time Frame
24 months after initial operation
Title
Clinical outcome 3
Description
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).
Time Frame
24 months after initial operation
Other Pre-specified Outcome Measures:
Title
Specific ankle provocation test
Description
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.
Time Frame
24 months after initial operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urs Zingg
Organizational Affiliation
Spital Limmattal Schlieren
Official's Role
Study Chair
Facility Information:
Facility Name
Spital Limmattal
City
Schlieren
State/Province
Zurich
ZIP/Postal Code
8952
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Operative Treatment of Ankle Fractures
We'll reach out to this number within 24 hrs