TraumaNCT01757951
Unimalleolar Versus Bimalleolar Fixation in Bi- or Trimalleolar Ankle Fracture
A study testing Unimalleolar fixation and Bimalleolar fixation in people with Trauma, run by University of Oulu at 1 site in Finland.
Trial summary
A one third of all ankle fractures are bi- or trimalleolar. Traditionally these fractures are treated by both medial and lateral osteosynthesis, sometimes accompanied by osteosynthesis of the posterior malleolus. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Trauma
- What is being tested?
- Unimalleolar fixation and Bimalleolar fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteFinland
- Study dates
- Feb 2012to Dec 2026
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Weber B bi- or trimalleolar ankle fracture (fracture of the lateral and medial malleolus +/- posterior malleolus sized under 30% of the distal tibia joint line measured from the lateral projection of the standard ankle radiographs)
- Age: 16 years or older
- Voluntary
- Operated within 7 days of the trauma
- Able to walk unaided before the current trauma
Who cannot join
- Peripheral neuropathy
- Pilon fracture
- Bilateral ankle fracture
- Concomitant tibial fracture
- Pathological fracture
- Active infection around the ankle
Show all 10Show fewer
- A previous ankle fracture on either side
- In trimalleolar fractures, posterior malleolus fracture sized over 30% of the distal tibia joint line measured from the lateral projection of the standard ankle radiographs
- Inadequate co-operation
- Permanent residence outside the catchment area of the study hospital
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Unimalleolar Versus Bimalleolar Fixation in Bi- or Trimalleolar Ankle Fracture - A Randomized Clinical Trial
A one third of all ankle fractures are bi- or trimalleolar. Traditionally these fractures are treated by both medial and lateral osteosynthesis, sometimes accompanied by osteosynthesis of the posterior malleolus. There is significant evidence that fractures of the lateral malleolus can be treated conservatively if the medial side is stable. However, there isn't a single study comparing standard bi- or trimalleolar fixation with only medial side osteosynthesis and postoperative immobilization with a cast.
- Conditions
- Trauma
- Being tested
- Unimalleolar fixation, Bimalleolar fixation
- Keywords
- Ankle, Fracture, medial malleolus, Osteosynthesis
- Medical subject headings
- Wounds and Injuries, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unimalleolar fixationProcedure or surgery
Medial malleolus is fixed first and after that ankle mortise stability is assessed using external-rotation stress test. If talocrural joint is stable after fixation of medial malleolus, the patient is randomized to unimalleolar fixation group and no fixation of the lateral side is performed.
Bimalleolar fixationProcedure or surgery
Medial malleolus is fixed first and after that ankle mortise stability is assessed using external-rotation stress test. If talocrural joint is stable after fixation of medial malleolus, the patient is randomized to bimalleolar fixation group i.e. additional fixation of the lateral malleolus fracture is performed.
| Study group | Role | What they receive |
|---|---|---|
| Unimalleolar Fixation | Experimental | Medial malleolus is fixed first and after that ankle mortise stability is assessed using external-rotation stress test. If talocrural joint is stable after fixation of medial malleolus, the patient is randomized to unimalleolar fixation group and no fixation of the lateral side is performed. Receives: Procedure: Unimalleolar fixation |
| Bimalleolar Fixation | Active comparator | Medial malleolus is fixed first and after that ankle mortise stability is assessed using external-rotation stress test. If talocrural joint is stable after fixation of medial malleolus, the patient is randomized to bimalleolar fixation group i.e. additional fixation of the lateral malleolus fracture is performed. Receives: Procedure: Bimalleolar fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Olerud-Molander Ankle Score
A validated, condition-specific, patient-reported measure of ankle fracture symptoms. Range from 0 to 100 points, with higher scores indicating better function
Measured: 2 years
Secondary outcomes (5)
The Foot and Ankle Outcome Score (FAOS)
FAOS, 5 subscales from 0-100, with higher scores indicating better function
Measured: 2 years
A 100 mm Visual Analogue Scale for function and pain (VAS)
Range from 0 to 100, with higher scores indicating more severe pain
Measured: 2 years
The RAND 36-Item Health Survey for health-related quality-of-life (RAND-36)
8 subscales from 0-100, with higher scores indicating better health-related quality of life
Measured: 2 years
Talocrural joint congruence
Medial clear space < 4 mm and ≤ 1 mm wider than the superior clear space as measured between the lateral border of the medial malleolus and the medial border of the talus at the level of the talar dome.
Measured: At two, four and 12 weeks, and at 2 years
Fracture healing
Fracture union is considered complete when the fracture line disappeared and conversely, those fractures with a visible fracture line are deemed non-unions.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2024 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: Partly due to financial issues and changes in study staff work placements
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harri Pakarinen, University of Oulu
- Investigators
- Harri J Pakarinen, MD, PhD, AP, Study director, Pohjois-Pohjanmaan sairaanhoitopiiri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01757951
- Sponsor's protocol ID
- OYSnilkka-RCT4
- Status last verified
- Nov 2022
- First submitted
- 21 Dec 2012
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unimalleolar Versus Bimalleolar Fixation in Bi- or Trimalleolar Ankle Fracture - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01757951
- Acronym / sponsor ID
- OYSnilkka-RCT4
- Conditions
- Trauma
- Keywords
- Ankle, Fracture, medial malleolus, Osteosynthesis
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Partly due to financial issues and changes in study staff work placements
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 31 Dec 2012 (estimated)
- 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.
A one third of all ankle fractures are bi- or trimalleolar. Traditionally these fractures are treated by both medial and lateral osteosynthesis, sometimes accompanied by osteosynthesis of the posterior malleolus. There is significant evidence that fractures of the lateral malleolus can be treated conservatively if the medial side is stable. However, there isn't a single study comparing standard bi- or trimalleolar fixation with only medial side osteosynthesis and postoperative immobilization with a cast.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unimalleolar Fixation | Experimental | Procedure: Unimalleolar fixationMedial malleolus is fixed first and after that ankle mortise stability is assessed using external-rotation stress test. If talocrural joint is stable after fixation of medial malleolus, the patient is randomized to unimalleolar fixation group and no fixation of the lateral side is performed. |
| Bimalleolar Fixation | Active comparator | Procedure: Bimalleolar fixationMedial malleolus is fixed first and after that ankle mortise stability is assessed using external-rotation stress test. If talocrural joint is stable after fixation of medial malleolus, the patient is randomized to bimalleolar fixation group i.e. additional fixation of the lateral malleolus fracture is performed. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Weber B bi- or trimalleolar ankle fracture (fracture of the lateral and medial malleolus +/- posterior malleolus sized under 30% of the distal tibia joint line measured from the lateral projection of the standard ankle radiographs)
- Age: 16 years or older
- Voluntary
- Operated within 7 days of the trauma
- Able to walk unaided before the current trauma
Key exclusion criteria (10 listed)
- Peripheral neuropathy
- Pilon fracture
- Bilateral ankle fracture
- Concomitant tibial fracture
- Pathological fracture
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 |
|---|---|---|
| Unimalleolar fixationMedial malleolus is fixed first and after that ankle mortise stability is assessed using external-rotation stress test. If talocrural joint is stable after fixation of medial malleolus, the patient is randomized to unimalleolar fixation group and no fixation of the lateral side is performed. | Procedure or surgery | Unimalleolar Fixation |
| Bimalleolar fixationMedial malleolus is fixed first and after that ankle mortise stability is assessed using external-rotation stress test. If talocrural joint is stable after fixation of medial malleolus, the patient is randomized to bimalleolar fixation group i.e. additional fixation of the lateral malleolus fracture is performed. | Procedure or surgery | Bimalleolar Fixation |
Primary outcome
Olerud-Molander Ankle Score
Time frame: 2 years
A validated, condition-specific, patient-reported measure of ankle fracture symptoms. Range from 0 to 100 points, with higher scores indicating better function
5 secondary outcomes
The Foot and Ankle Outcome Score (FAOS)
Time frame: 2 years
A 100 mm Visual Analogue Scale for function and pain (VAS)
Time frame: 2 years
The RAND 36-Item Health Survey for health-related quality-of-life (RAND-36)
Time frame: 2 years
Talocrural joint congruence
Time frame: At two, four and 12 weeks, and at 2 years
Fracture healing
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
Related trials for Trauma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
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.
Harri J Pakarinen, MD, PhD, AP study director
Pohjois-Pohjanmaan sairaanhoitopiiri
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unimalleolar fixation and Bimalleolar fixation in people with Trauma, run by University of Oulu at 1 site in Finland.
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 5 inclusion and 10 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: paused, as of the sponsor's last update on 2 Nov 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 Finland. 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?
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 (time frame: 2 years). 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 2 Nov 2022.