Ankle FracturesPRO-MalleolNCT03107767
Study of Re-operation Rate After Introduction of Evidence Based Algorithm for the Treatment of Ankle Fractures
A study testing PRO-malleol algorithm in people with Ankle Fractures and Surgery, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
There is a high incidence of re-operations after surgery for ankle fractures. According to the Danish Fracture Database (DFDB) the re-operation rate, excluding hardware removal, is almost 10%. We are conducting a study on the efficacy of an evidence based algorithm for the treatment of ankle fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Fractures, Surgery, Syndesmotic Injuries
- What is being tested?
- PRO-malleol algorithm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2016to 1 Jun 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients treated for ankle fractures at our institution during the study period are asked to participate in the study.
Who cannot join
- Not speaking danish Not followed up at our institution Not mentally capable of filling out questionnaire
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Hvidovre University Hospital
Hvidovre, 2650
Peter T Tengberg, MD, +4561663676, ptofttengberg@gmail.com
Peter T Tengberg, MD, +4522971007, peter.toft.tengberg@regionh.dk
About this study
Official title: The PRO-malleol Study
There is a high incidence of re-operations after surgery for ankle fractures. According to the Danish Fracture Database (DFDB) the re-operation rate, excluding hardware removal, is almost 10%.
We are conducting a study on the efficacy of an evidence based algorithm for the treatment of ankle fractures.
Read the detailed description
Treatment of ankle fractures is complex and includes assessment of fracture pattern, severity of soft-tissue involvement and general health- and functional status of the patients. Historically most fractures, undisplaced as well as displaced, were treated non-operatively with acceptable results but in recent years there is an increasing trend towards operative management of unstable fractures. Techniques for operative management of ankle fractures are varied and assessment of instability is mainly based on classic x-ray classification systems such as Lauge-Hansen or the AO that are difficult to reproduce[6].
We hypothesize that a standardized and evidence based approach to ankle fracture management will lead to a decrease in re-operation rate.
The aim of this study is to standardize the management of ankle fractures in our department, by introducing an algorithm based on best evidence present. We want to investigate:
- The effect of this algorithm on the re-operation rate of surgically treated ankle fractures in a two-year prospective observational setup with a minimum of one-year of follow-up.
- The need for surgery and functional outcome of patients with isolated lateral malleolus fractures in which the treatment is dictated by ankle stability assessed on weight bearing radiographs.
- Being tested
- PRO-malleol algorithm
- Medical subject headings
- Ankle Fractures, Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRO-malleol algorithmProcedure or surgery
An evidence based algorithm for ankle fractures
| Study group | Role | What they receive |
|---|---|---|
| Prospective Cohort | Active comparator | The prospective cohort following introduction of the evidence based algorithm for ankle fractures. Receives: Procedure: PRO-malleol algorithm |
| Historical Cohort | No intervention | Patients treated before introduction of algorithm. Matched to prospective cohort for comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in re-operation rate
Change in re-operation rate following introduction of PRO malleol algorithm
Measured: one year
Rate of surgery for isolated lateral ankle fractures
Rate of surgery for isolated lateral ankle fractures, following introduction of algorithm
Measured: one year
Secondary outcomes (4)
SF 36
SF 36 before fracture and at 12 months
Measured: day 0 and 12 months
Ollerud Molander Ankle Score
Measured: Before fracture, 6 weeks, 12 weeks and 1 year
Forgotten Joint Score
Before fracture, 6 weeks, 12 weeks and 1 year
Measured: Before fracture, 6 weeks, 12 weeks and 1 year
Rate of complications not requiring surgery
DVT, Nerve damage,
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start1 Jun 2016
- Primary completion1 Jun 2018 (estimated)
- Study completion1 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle FracturesStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- A prospective cohort, following the introduction of an evidence based algorithm, will be compared to a matched historical cohort from the previous years.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Toft Tengberg, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03107767
- Sponsor's protocol ID
- PRO-Malleol study
- Acronym
- PRO-Malleol
- Status last verified
- Apr 2017
- First submitted
- 5 Apr 2017
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be anonymized and openly shared with any who requests it, after study publication.
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PRO-malleol Study
- ClinicalTrials.gov ID
- NCT03107767
- Acronym / sponsor ID
- PRO-Malleol / PRO-Malleol study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Jun 2018 (estimated)
- Study completion
- 1 Jun 2019 (estimated)
- First posted
- 11 Apr 2017 (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.
There is a high incidence of re-operations after surgery for ankle fractures. According to the Danish Fracture Database (DFDB) the re-operation rate, excluding hardware removal, is almost 10%.
We are conducting a study on the efficacy of an evidence based algorithm for the treatment of ankle fractures.
Detailed description
Treatment of ankle fractures is complex and includes assessment of fracture pattern, severity of soft-tissue involvement and general health- and functional status of the patients. Historically most fractures, undisplaced as well as displaced, were treated non-operatively with acceptable results but in recent years there is an increasing trend towards operative management of unstable fractures. Techniques for operative management of ankle fractures are varied and assessment of instability is mainly based on classic x-ray classification systems such as Lauge-Hansen or the AO that are difficult to reproduce[6].
We hypothesize that a standardized and evidence based approach to ankle fracture management will lead to a decrease in re-operation rate.
The aim of this study is to standardize the management of ankle fractures in our department, by introducing an algorithm based on best evidence present. We want to investigate:
- The effect of this algorithm on the re-operation rate of surgically treated ankle fractures in a two-year prospective observational setup with a minimum of one-year of follow-up.
- The need for surgery and functional outcome of patients with isolated lateral malleolus fractures in which the treatment is dictated by ankle stability assessed on weight bearing radiographs.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective cohort, following the introduction of an evidence based algorithm, will be compared to a matched historical cohort from the previous years.
| Arm | Type | Receives |
|---|---|---|
| Prospective Cohort | Active comparator | Procedure: PRO-malleol algorithmThe prospective cohort following introduction of the evidence based algorithm for ankle fractures. |
| Historical Cohort | No intervention | –Patients treated before introduction of algorithm. Matched to prospective cohort for comparison |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients treated for ankle fractures at our institution during the study period are asked to participate in the study.
Key exclusion criteria (1 listed)
- Not speaking danish Not followed up at our institution Not mentally capable of filling out questionnaire
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 |
|---|---|---|
| PRO-malleol algorithmAn evidence based algorithm for ankle fractures | Procedure or surgery | Prospective Cohort |
Primary outcome
Change in re-operation rate
Time frame: one year
Change in re-operation rate following introduction of PRO malleol algorithm
Rate of surgery for isolated lateral ankle fractures
Time frame: one year
Rate of surgery for isolated lateral ankle fractures, following introduction of algorithm
4 secondary outcomes
SF 36
Time frame: day 0 and 12 months
Ollerud Molander Ankle Score
Time frame: Before fracture, 6 weeks, 12 weeks and 1 year
Forgotten Joint Score
Time frame: Before fracture, 6 weeks, 12 weeks and 1 year
Rate of complications not requiring surgery
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- Individual participant dataSharing planned: Yes. Data will be anonymized and openly shared with any who requests it, after study publication.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRO-malleol algorithm in people with Ankle Fractures and Surgery, run by Hvidovre University Hospital at 1 site in Denmark.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Apr 2017. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in re-operation rate (time frame: one year). 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 11 Apr 2017.