Malleolus Fracture, LateralPhase 4NCT03587571
Comparing Function, Pain and Return to Work in Conservative Versus Surgical Treated Stable Lateral Malleolar Fractures
A Phase 4 study testing Surgical intervention in people with Malleolus Fracture, Lateral, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Ankle fractures are one of the most common fractures in adults resulting in hospital stays and inability to work. Instable or dislocated ankle fractures are mostly treated by surgery. Treatment of stable lateral ankle fractures is still discussed controversial. They can be treated conservatively as well as by surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Malleolus Fracture, Lateral
- What is being tested?
- Surgical intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 May 2018to 31 Dec 2019
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- Acute, stable lateral malleolar fracture
- Definition of stable:
- Less than 2mm dislocation in a.p., lateral and gravity-stress x-ray
- Medial tibiotalar distance <4mm and difference <1mm compared to the superior clear space on the gravity-stress and weight bearing x-ray
- No talar subluxation
Show all 11Show fewer
- No intraoperative instability (Hook-/Frick-Test)
- Between 18 and 65 years old
- Living in Switzerland
- Working
- Cognitive and physic ability to follow the study protocol
Who cannot join
- Instable fractures
- Previous ipsilateral surgery on the ankle or foot
- Pregnancy
- Diabetes mellitus
- Neurologic or vascular impairment
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- Previous enrolment into the current study
- Enrolment of the investigator, his/her family members, employees and other dependent persons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Randomized Multi-center Study Comparing Function, Pain and Return to Work in Conservative Versus Surgical Treated Stable Lateral Malleolar Fractures
Ankle fractures are one of the most common fractures in adults resulting in hospital stays and inability to work. Instable or dislocated ankle fractures are mostly treated by surgery. Treatment of stable lateral ankle fractures is still discussed controversial. They can be treated conservatively as well as by surgery.
Furthermore, optimal aftercare is part of on-going discussion in both groups. Goal of any treatment is a fast, good functional outcome with pain free patients at low overall costs. Long-term results in terms of osteoarthritis should be kept in mind.
Read more
The investigators seek to compare conservative and operative treatment in stable lateral ankle fractures in a prospective, randomised trial.
The hypothesis is that there is no difference between conservative and surgically treated stable lateral malleolar fractures regarding pain, function, and return to the workplace.
Read the detailed description
Ankle fractures are one of the most common fractures in adults resulting in hospital stays and inability to work. Instable or dislocated ankle fractures are mostly treated by surgery. Treatment of stable lateral ankle fractures is still discussed controversial. They can be treated conservatively as well as by surgery.
Furthermore, optimal aftercare is part of on-going discussion in both groups. Goal of any treatment is a fast, good functional outcome with pain free patients at low overall costs. Long-term results in terms of osteoarthritis should be kept in mind.
Primary study objective is the comparison of functional result after conservative versus operative treatment in stable lateral ankle fractures.
Secondary study objectives are the return to work, pain, and osteoarthritis. It is a prospective, randomised (site stratified block randomisation) multi-center clinical trial. The two treatment options are split in two study arms and compared to each other.
Measurements and procedures:
People with acute stable lateral malleolar fracture type Weber B are potential participants. Patients are recruited at their first visit in the emergency department or on the first contact with the orthopaedic department. They have to live in Switzerland in order to be able to show up at the regular visits. They have to work in order to gain information concerning the timeframe for return to work.
No vulnerable participants are included. The two treatment options (operative versus conservative) are split in two study arms and compared to each other. Patients are randomly allocated to one of the two study arms. A central block randomisation with 80 participants per block is installed in REDCap. At time of participating in the study, REDCap is assigning the patient to one of the study groups.
After enrolling in the study at the first visit a split cast is applied in both group. Surgical intervention should be performed within 2 weeks after trauma. The exact time of surgery is determined by the treating surgeon and documented. In the surgical group open reduction and osteosynthesis by plating is done.
In the conservative group clinical and radiological re-evaluation is done within the first 2 weeks after trauma.
Both groups are further treated with an orthosis and allowed to bear weight as possible.
At time of accident, within the first two weeks, after 6 and 12 weeks, after 1, 3 and 5 years the patient is examined clinically and radiologically. Olerud Molander Ankle Score (OMAS), Foot Function Index (FFI), American Orthopaedic Foot and Ankle Society Score (AOFAS), Visual Analogue Scale Foot and Ankle (VAS FA) and epidemiological and clinical findings are gathered. Patients who do not reach the 12 weeks follow-up will be considered drop-outs and must be replaced. In accordance to the intention to treat analysis (ITT-analysis) data will be included in the statistical analysis. Multiple imputation technique will be used to analyze missing data. Every effort will be undertaken to complete any trial participation. Data are recorded by paper Case Report Forms (CRF). For each enrolled study participant a CRF is maintained. The CRFs in this trial are implemented electronically using a dedicated electronic data capturing (EDC) system (REDCap).
Number of Participants with Rationale:
According to the power analysis (power=0.8, one sided Wilcoxon rank sum test, alpha-error 0,05, SD=7, unimportant difference≤3) 69 patients are needed per study arm to state a non-inferiority in both groups. A drop out or lost to follow up rate at approximately 10-15% is expected. Therefore 80 patients are needed per study arm (overall 160 patients).
Statistical Considerations:
Descriptive statistics are used in order to analyse demographic data (age, gender, inability to work, return to work, distribution of occupation, etc.) The main outcome is the OMAS after 12 weeks. The hypothesis is that there is no difference between conservative and surgically treated stable lateral malleolar fractures regarding pain, function, and return to the workplace.
Descriptive statistic with specification of the 95% confidence interval is used for the secondary outcome parameters. If applicable a multivariance analysis is intended.
- Conditions
- Malleolus Fracture, Lateral
- Being tested
- Surgical intervention
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical interventionProcedure or surgery
Open reduction and plate osteosynthesis.
| Study group | Role | What they receive |
|---|---|---|
| Surgical intervention | Active comparator | Open reduction and osteosynthesis by plating is done. Further after treatment is similar to conservative treatment arm. Receives: Procedure: Surgical intervention |
| Conservative treatment | No intervention | At the first visit a split cast is applied. Afterwards physiotherapy and weightbearing as tolerated is allowed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Olerud-Molander Ankle Score (OMAS)
The OMAS Score is a patient-reported scale from 0 (totally impaired) to 100 (completely unimpaired) to evaluate subjectively scored function after ankle fracture. It consists of 9 questions: pain (0 to 25), stiffness (0 to 10), swelling (0 to 10), stair climbing (0 to 10), running (0 to 5), jumping (0 to 5), squatting (0 to 5), use of supports (0 to 10), and work/activity level (0 to 20), with higher scores indicating better outcomes
Measured: after 12 weeks
Secondary outcomes (5)
The Visual Analogue Scale Foot and Ankle (VAS FA)
The VAS FA is a questionnaire based on 20 questions requiring purely subjective answers; 3 different question categories (pain, n=4 questions; function, n=11, other complaints n=5) with a possible maximum of 100 points.
Measured: at time of accident, within the first two weeks, after 6 and 12 weeks, after 1, 3 and 5 years
American Orthopedic Foot and Ankle Society Score (AOFAS)
The AOFAS Score is used for measuring the outcome of treatment in patients who sustained a complex ankle or hindfoot injury. It combines a clinician-reported and a patient-reported part. The questionnaire consists of 9 questions and covers 3 categories: pain (40points), function (50 points) and alignment (10points). These are all scored together for a total of 100 points, indicating no symptoms or impairments.
Measured: at time of accident, within the first two weeks, after 6 and 12 weeks, after 1, 3 and 5 years
Foot Function Index (FFI)
The FFI was developed to measure the impact of foot pathology on function in terms of pain, disability and activity restriction. The FFI questionnaire consists of 18 self-reported items divided into 3 subcategories: pain, disability and activity limitation. The patient has to score each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it requires help). Both total and subcategory scores are calculated.
Measured: at time of accident, within the first two weeks, after 6 and 12 weeks, after 1, 3 and 5 years
Return to work
yes, no or partial (%)
Measured: at time of accident, within the first two weeks, after 6 and 12 weeks, after 1, 3 and 5 years
Kellgren-Lawrence scale
The Kellgren Lawrence grading system is a radiological classification of osteoarthritis. It progresses from grade 0 (no radiographic features of osteoarthritis) to grade IV (signifying severe osteoarthritis) and is based on radiographs.
Measured: at time of accident, within the first two weeks, after 6 and 12 weeks, after 1, 3 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study start1 May 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Why it stopped: Insufficient patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malleolus Fracture, LateralStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison of two established treatment options. Prospective, randomised (central block randomisation) multi-center clinical trial. The two treatment options (operative versus conservative) are split in two study arms and compared to each other. Patients are randomly allocated to one of the two study arms.
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabian Krause, PD Dr., Principal investigator, Dep. of Orthopaedic Surgery, Inselspital, University of Berne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03587571
- Sponsor's protocol ID
- 2017-01041
- Other IDs
- 2017
- Status last verified
- Mar 2023
- First submitted
- 28 Jun 2018
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Multi-center Study Comparing Function, Pain and Return to Work in Conservative Versus Surgical Treated Stable Lateral Malleolar Fractures
- ClinicalTrials.gov ID
- NCT03587571
- Acronym / sponsor ID
- 2017-01041
- Conditions
- Malleolus Fracture, Lateral
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient patient recruitment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 16 Jul 2018 (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.
Ankle fractures are one of the most common fractures in adults resulting in hospital stays and inability to work. Instable or dislocated ankle fractures are mostly treated by surgery. Treatment of stable lateral ankle fractures is still discussed controversial. They can be treated conservatively as well as by surgery.
Furthermore, optimal aftercare is part of on-going discussion in both groups. Goal of any treatment is a fast, good functional outcome with pain free patients at low overall costs. Long-term results in terms of osteoarthritis should be kept in mind.
The investigators seek to compare conservative and operative treatment in stable lateral ankle fractures in a prospective, randomised trial.
The hypothesis is that there is no difference between conservative and surgically treated stable lateral malleolar fractures regarding pain, function, and return to the workplace.
Detailed description
Ankle fractures are one of the most common fractures in adults resulting in hospital stays and inability to work. Instable or dislocated ankle fractures are mostly treated by surgery. Treatment of stable lateral ankle fractures is still discussed controversial. They can be treated conservatively as well as by surgery.
Furthermore, optimal aftercare is part of on-going discussion in both groups. Goal of any treatment is a fast, good functional outcome with pain free patients at low overall costs. Long-term results in terms of osteoarthritis should be kept in mind.
Primary study objective is the comparison of functional result after conservative versus operative treatment in stable lateral ankle fractures.
Secondary study objectives are the return to work, pain, and osteoarthritis. It is a prospective, randomised (site stratified block randomisation) multi-center clinical trial. The two treatment options are split in two study arms and compared to each other.
Measurements and procedures:
People with acute stable lateral malleolar fracture type Weber B are potential participants. Patients are recruited at their first visit in the emergency department or on the first contact with the orthopaedic department. They have to live in Switzerland in order to be able to show up at the regular visits. They have to work in order to gain information concerning the timeframe for return to work.
No vulnerable participants are included. The two treatment options (operative versus conservative) are split in two study arms and compared to each other. Patients are randomly allocated to one of the two study arms. A central block randomisation with 80 participants per block is installed in REDCap. At time of participating in the study, REDCap is assigning the patient to one of the study groups.
After enrolling in the study at the first visit a split cast is applied in both group. Surgical intervention should be performed within 2 weeks after trauma. The exact time of surgery is determined by the treating surgeon and documented. In the surgical group open reduction and osteosynthesis by plating is done.
In the conservative group clinical and radiological re-evaluation is done within the first 2 weeks after trauma.
Both groups are further treated with an orthosis and allowed to bear weight as possible.
At time of accident, within the first two weeks, after 6 and 12 weeks, after 1, 3 and 5 years the patient is examined clinically and radiologically. Olerud Molander Ankle Score (OMAS), Foot Function Index (FFI), American Orthopaedic Foot and Ankle Society Score (AOFAS), Visual Analogue Scale Foot and Ankle (VAS FA) and epidemiological and clinical findings are gathered. Patients who do not reach the 12 weeks follow-up will be considered drop-outs and must be replaced. In accordance to the intention to treat analysis (ITT-analysis) data will be included in the statistical analysis. Multiple imputation technique will be used to analyze missing data. Every effort will be undertaken to complete any trial participation. Data are recorded by paper Case Report Forms (CRF). For each enrolled study participant a CRF is maintained. The CRFs in this trial are implemented electronically using a dedicated electronic data capturing (EDC) system (REDCap).
Number of Participants with Rationale:
According to the power analysis (power=0.8, one sided Wilcoxon rank sum test, alpha-error 0,05, SD=7, unimportant difference≤3) 69 patients are needed per study arm to state a non-inferiority in both groups. A drop out or lost to follow up rate at approximately 10-15% is expected. Therefore 80 patients are needed per study arm (overall 160 patients).
Statistical Considerations:
Descriptive statistics are used in order to analyse demographic data (age, gender, inability to work, return to work, distribution of occupation, etc.) The main outcome is the OMAS after 12 weeks. The hypothesis is that there is no difference between conservative and surgically treated stable lateral malleolar fractures regarding pain, function, and return to the workplace.
Descriptive statistic with specification of the 95% confidence interval is used for the secondary outcome parameters. If applicable a multivariance analysis is intended.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparison of two established treatment options. Prospective, randomised (central block randomisation) multi-center clinical trial. The two treatment options (operative versus conservative) are split in two study arms and compared to each other. Patients are randomly allocated to one of the two study arms.
| Arm | Type | Receives |
|---|---|---|
| Surgical intervention | Active comparator | Procedure: Surgical interventionOpen reduction and osteosynthesis by plating is done. Further after treatment is similar to conservative treatment arm. |
| Conservative treatment | No intervention | –At the first visit a split cast is applied. Afterwards physiotherapy and weightbearing as tolerated is allowed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- Acute, stable lateral malleolar fracture
- Less than 2mm dislocation in a.p., lateral and gravity-stress x-ray
- Medial tibiotalar distance <4mm and difference <1mm compared to the superior clear space on the gravity-stress and weight bearing x-ray
- No talar subluxation
Key exclusion criteria (8 listed)
- Instable fractures
- Previous ipsilateral surgery on the ankle or foot
- Pregnancy
- Diabetes mellitus
- Neurologic or vascular impairment
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 |
|---|---|---|
| Surgical interventionOpen reduction and plate osteosynthesis. | Procedure or surgery | Surgical intervention |
Primary outcome
Olerud-Molander Ankle Score (OMAS)
Time frame: after 12 weeks
The OMAS Score is a patient-reported scale from 0 (totally impaired) to 100 (completely unimpaired) to evaluate subjectively scored function after ankle fracture. It consists of 9 questions: pain (0 to 25), stiffness (0 to 10), swelling (0 to 10), stair climbing (0 to 10), running (0 to 5), jumping (0 to 5), squatting (0 to 5), use of supports (0 to 10), and work/activity level (0 to 20), with higher scores indicating better outcomes
5 secondary outcomes
The Visual Analogue Scale Foot and Ankle (VAS FA)
Time frame: at time of accident, within the first two weeks, after 6 and 12 weeks, after 1, 3 and 5 years
American Orthopedic Foot and Ankle Society Score (AOFAS)
Time frame: at time of accident, within the first two weeks, after 6 and 12 weeks, after 1, 3 and 5 years
Foot Function Index (FFI)
Time frame: at time of accident, within the first two weeks, after 6 and 12 weeks, after 1, 3 and 5 years
Return to work
Time frame: at time of accident, within the first two weeks, after 6 and 12 weeks, after 1, 3 and 5 years
Kellgren-Lawrence scale
Time frame: at time of accident, within the first two weeks, after 6 and 12 weeks, after 1, 3 and 5 years
Results and safety
The study was stopped early (reason given: Insufficient patient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
Fabian Krause, PD Dr. principal investigator
Dep. of Orthopaedic Surgery, Inselspital, University of Berne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Surgical intervention in people with Malleolus Fracture, Lateral, run by Insel Gruppe AG, University Hospital Bern 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 11 inclusion and 8 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: stopped early, as of the sponsor's last update on 8 Mar 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Insufficient patient recruitment). Results are not available in the source record.
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?
Olerud-Molander Ankle Score (OMAS) (time frame: after 12 weeks). 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 8 Mar 2023.