Ankle Fracture, TrimalleolarNCT04437355
Operative Treatment of Ankle Fractures
A study testing Specific provocation test in people with Ankle Fracture, Trimalleolar and Ankle Fracture - Lateral Malleolus, run by Spital Limmattal Schlieren at 1 site in Switzerland.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankle Fracture, Trimalleolar, Ankle Fracture - Lateral Malleolus, Ankle Fracture, Bimalleolar
- What is being tested?
- Specific provocation test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Clinical, Functional and Radiological Outcome After Osteosynthesis of Ankle Fractures Using a Specific Provocation Test- a Combined Retro- and Prospective Study
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
Read the 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.
- Conditions
- Ankle Fracture, Trimalleolar, Ankle Fracture - Lateral Malleolus, Ankle Fracture, Bimalleolar
- Being tested
- Specific provocation test
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific provocation testDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Young and healthy Group of People (18-50 years) without any pathology of the lower limb Receives: Diagnostic Test: Specific provocation test |
| Ankle Fracture Type Weber B | Active comparator | Young and healthy patients with an operative treated fracture of the ankle (type Weber B) Receives: Diagnostic Test: Specific provocation test |
| Ankle Fracture Weber C and complex | Active comparator | Young and healthy patients with an operative treated fracture of the ankle (type Weber C or complex fracture) Receives: Diagnostic Test: Specific provocation test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at least two year after surgery or one year after removal of the osteosynthetic material
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.)
Measured: 24 months after initial operation
Secondary outcomes (3)
Clinical outcome 1
- VAS: Visual analogue score 1-10
Explanation: 1 means almost no pain, 10 is the worst pain one can imagine
Measured: 24 months after initial operation
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.
Measured: 24 months after initial operation
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).
Measured: 24 months after initial operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start1 Jul 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle Fracture, TrimalleolarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spital Limmattal Schlieren
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Urs Zingg, Spital Limmattal Schlieren
- Investigators
- Urs Zingg, Study chair, Spital Limmattal Schlieren
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437355
- Sponsor's protocol ID
- 2018-01124
- Other IDs
- 2018
- Status last verified
- Oct 2022
- First submitted
- 7 Jan 2020
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Functional and Radiological Outcome After Osteosynthesis of Ankle Fractures Using a Specific Provocation Test- a Combined Retro- and Prospective Study
- ClinicalTrials.gov ID
- NCT04437355
- Acronym / sponsor ID
- 2018-01124
- Conditions
- Ankle Fracture, Trimalleolar, Ankle Fracture - Lateral Malleolus, Ankle Fracture, Bimalleolar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Spital Limmattal SchlierenUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Diagnostic Test: Specific provocation testYoung and healthy Group of People (18-50 years) without any pathology of the lower limb |
| Ankle Fracture Type Weber B | Active comparator | Diagnostic Test: Specific provocation testYoung and healthy patients with an operative treated fracture of the ankle (type Weber B) |
| Ankle Fracture Weber C and complex | Active comparator | Diagnostic Test: Specific provocation testYoung and healthy patients with an operative treated fracture of the ankle (type Weber C or complex fracture) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specific provocation testTo 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. | Diagnostic test | Ankle Fracture Type Weber B, Ankle Fracture Weber C and complex, Control Group |
Primary outcome
Functional outcome
Time frame: at least two year after surgery or one year after removal of the osteosynthetic material
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
Time frame: 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.)
3 secondary outcomes
Clinical outcome 1
Time frame: 24 months after initial operation
Clinical outcome 2
Time frame: 24 months after initial operation
Clinical outcome 3
Time frame: 24 months after initial operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Urs Zingg study chair
Spital Limmattal Schlieren
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific provocation test in people with Ankle Fracture, Trimalleolar and Ankle Fracture - Lateral Malleolus, run by Spital Limmattal Schlieren at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcome (time frame: at least two year after surgery or one year after removal of the osteosynthetic material). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.