Ankle FractureNCT06559111
Cast or Functional Ankle Orthosis After Ankle Fracture Surgery
A study testing 2-week casting followed by 4-week bracing and 6-week casting in people with Ankle Fracture and Postoperative Treatment, run by Töölö Hospital.
Trial summary
The goal of this randomized clinical trial was to compare the effect of 6-week casting versus 2-week casting followed by 4-week ankle bracing in adult patients with surgically treated ankle fractures. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ankle Fracture, Postoperative Treatment
- What is being tested?
- 2-week casting followed by 4-week bracing and 6-week casting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2005to 16 Mar 2012
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Weber A or B type ankle fracture
- uni-, bi- or trimalleolar injury and/or fibular displacement of >2 mm in any plane on the radiographs
Who cannot join
- Weber C injury necessitating syndesmotic fixation
- Pilon injury
- Inadequate co-operation
- Other severe concomitant injuries
About this study
Official title: Postoperative Care After Operatively Treated Ankle Fractures With Cast or Functional Ankle Orthosis. A 2-year, Prospective, Randomized Clinical Trial
The goal of this randomized clinical trial was to compare the effect of 6-week casting versus 2-week casting followed by 4-week ankle bracing in adult patients with surgically treated ankle fractures.
The primary outcome measures used were the functional results 3 months after surgery evaluated using two functional outcome measures (Olerud and Molander score and Kaikkonen score) and the patient return to work.
In the casting group, the traditional plaster was changed to a fiberglass one at 2 weeks and the cast treatment continued until 6 weeks. In the functional treatment group, the traditional plaster cast was changed to an reusable semi-rigid plastic orthosis (Aircast) at 2 weeks after surgery and its use was continued as an ankle support for up to 6 weeks. Follow-ups including subjective and objective evaluations were at 2, 6, 12 and 52 weeks and at 2 years postoperatively.
- Conditions
- Ankle Fracture, Postoperative Treatment
- Being tested
- 2-week casting followed by 4-week bracing, 6-week casting
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-week casting followed by 4-week bracingDevice
Participants in the bracing group had a cast for 2 weeks after the surgery followed by ankle brace for 4 weeks.
6-week castingDevice
Participants in the casting group had a cast for 6 weeks after the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Bracing group | Experimental | Participants in the bracing group had a cast for 2 weeks after the surgery followed by ankle brace for 4 weeks. Receives: Device: 2-week casting followed by 4-week bracing |
| Casting group | Active comparator | Participants in the casting group had a cast for 6 weeks after the surgery. Receives: Device: 6-week casting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Olerud-Molander score
Patient-reported outcome measure, 0-100 points, higher points indicating better result.
Measured: 3 months and 24 months
Secondary outcomes (9)
Olerud-Molander score
Patient-reported outcome measure, 0-100 points, higher points indicating better result.
Measured: 6 weeks and 12 months
Kaikkonen score
Patient-reported outcome measure, 0-100 points, higher points indicating better result.
Measured: 6 weeks, 3, 12, and 24 months
Visual Analog Scale for Pain
0-10, higher score indicating more pain.
Measured: 6 weeks, 3, 12, and 24 months
Swelling of the ankle
Circumference in millimetres compared to unaffected side
Measured: 6 weeks, 3, 12, and 24 months
Atrophy of the calf muscles
Circumference in millimetres compared to unaffected side
Measured: 6 weeks, 3, 12, and 24 months
Ankle active dorsiflexion
Degrees compared to unaffected side
Measured: 6 weeks, 3, 12, and 24 months
Ankle active plantarflexion
Degrees compared to unaffected side
Measured: 6 weeks, 3, 12, and 24 months
Return-to-work
Days after the injury
Measured: Within 24 months
Subjective symptoms and return to activities
The patients were questioned about the subjective symptoms (pain, swelling, stiffness and giving way) and about the compliance of using the cast or brace. In addition the patients were asked about the length of their inability to work and participate in the daily activities and/or sports at the preinjury level.
Measured: 2 and 6 weeks; 3, 12, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start1 Dec 2005
- Primary completion16 Jun 2010
- Study completion16 Mar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle FractureStudies 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
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Töölö Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University Hospital
- Responsible party
- Principal investigator, Lasse Rämö, Helsinki University Central Hospital
- Investigators
- Teppo Järvinen, Prof, Study chair, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559111
- Sponsor's protocol ID
- 06121917
- Status last verified
- Apr 2025
- First submitted
- 14 Aug 2024
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Care After Operatively Treated Ankle Fractures With Cast or Functional Ankle Orthosis. A 2-year, Prospective, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06559111
- Acronym / sponsor ID
- 06121917
- Conditions
- Ankle Fracture, Postoperative Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Töölö HospitalUniversity, hospital or other
- Collaborators
- Tampere University Hospital
- Study start
- 1 Dec 2005 (actual)
- Primary completion
- 16 Jun 2010 (actual)
- Study completion
- 16 Mar 2012 (actual)
- First posted
- 19 Aug 2024 (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.
The goal of this randomized clinical trial was to compare the effect of 6-week casting versus 2-week casting followed by 4-week ankle bracing in adult patients with surgically treated ankle fractures.
The primary outcome measures used were the functional results 3 months after surgery evaluated using two functional outcome measures (Olerud and Molander score and Kaikkonen score) and the patient return to work.
In the casting group, the traditional plaster was changed to a fiberglass one at 2 weeks and the cast treatment continued until 6 weeks. In the functional treatment group, the traditional plaster cast was changed to an reusable semi-rigid plastic orthosis (Aircast) at 2 weeks after surgery and its use was continued as an ankle support for up to 6 weeks. Follow-ups including subjective and objective evaluations were at 2, 6, 12 and 52 weeks and at 2 years postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Bracing group | Experimental | Device: 2-week casting followed by 4-week bracingParticipants in the bracing group had a cast for 2 weeks after the surgery followed by ankle brace for 4 weeks. |
| Casting group | Active comparator | Device: 6-week castingParticipants in the casting group had a cast for 6 weeks after the surgery. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Weber A or B type ankle fracture
- uni-, bi- or trimalleolar injury and/or fibular displacement of >2 mm in any plane on the radiographs
Key exclusion criteria (4 listed)
- Weber C injury necessitating syndesmotic fixation
- Pilon injury
- Inadequate co-operation
- Other severe concomitant injuries
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 |
|---|---|---|
| 2-week casting followed by 4-week bracingParticipants in the bracing group had a cast for 2 weeks after the surgery followed by ankle brace for 4 weeks. | Device | Bracing group |
| 6-week castingParticipants in the casting group had a cast for 6 weeks after the surgery. | Device | Casting group |
Primary outcome
Olerud-Molander score
Time frame: 3 months and 24 months
Patient-reported outcome measure, 0-100 points, higher points indicating better result.
9 secondary outcomes
Olerud-Molander score
Time frame: 6 weeks and 12 months
Kaikkonen score
Time frame: 6 weeks, 3, 12, and 24 months
Visual Analog Scale for Pain
Time frame: 6 weeks, 3, 12, and 24 months
Swelling of the ankle
Time frame: 6 weeks, 3, 12, and 24 months
Atrophy of the calf muscles
Time frame: 6 weeks, 3, 12, and 24 months
Ankle active dorsiflexion
Time frame: 6 weeks, 3, 12, and 24 months
Ankle active plantarflexion
Time frame: 6 weeks, 3, 12, and 24 months
Return-to-work
Time frame: Within 24 months
Subjective symptoms and return to activities
Time frame: 2 and 6 weeks; 3, 12, and 24 months
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 11 Apr 2025.
- 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.
Teppo Järvinen, Prof study chair
Helsinki University Central Hospital
Questions about this trial
What is this clinical trial studying?
A study testing 2-week casting followed by 4-week bracing and 6-week casting in people with Ankle Fracture and Postoperative Treatment, run by Töölö Hospital.
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 2 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 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Olerud-Molander score (time frame: 3 months and 24 months). 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 2025; AzTrials last refreshed its copy on 6 Nov 2026.