Ankle Malleolus Fracture BimalleolarNCT01441817
Non--operative Treatment of the Medial Malleolus in bi- and Trimalleolar Ankle Fractures
A study testing Internal fixation in people with Ankle Malleolus Fracture Bimalleolar and Fracture of Medial Malleolus, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The purpose of this study was to determine if internal fixation of the medial malleolus is necessary following open reduction and internal fixation of the lateral and, if required, the posterior malleolus treating displaced bi-or trimalleolar ankle fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Malleolus Fracture Bimalleolar, Fracture of Medial Malleolus, Fracture of Ankle
- What is being tested?
- Internal fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- May 2002to Aug 2008
- 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
- Patients with Orthopaedic Trauma Association (OTA) type 44 fractures (B2-3 and C2-3).
Who cannot join
- Patients with OTA type 43 distal tibia fractures.
- Patients with soft tissue injuries involving the medial malleolus.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non--operative Treatment of the Medial Malleolus in bi- and Trimalleolar Ankle Fractures. A Randomized Controlled Trial
The purpose of this study was to determine if internal fixation of the medial malleolus is necessary following open reduction and internal fixation of the lateral and, if required, the posterior malleolus treating displaced bi-or trimalleolar ankle fractures.
- Being tested
- Internal fixation
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internal fixationProcedure or surgery
Internal fixation of the medial malleolus following open reduction and internal fixation of the lateral and, if required, posterior malleolus.
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Other | Not described Receives: Procedure: Internal fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Orthopaedic Foot and Ankle Society ankle hind foot score (AOFAS)
Measured: Average of 42 months
The Olerud Molander Ankle score (OMAS)
Measured: Average of 42 months
Secondary outcomes (2)
Posttraumatic osteoarthritis (OA) according to the criteria of Magnusson (stage I-IV)
Measured: Average of 42 months
VAS score
Pain evaluated at rest, in the morning, in the evening and during the night.
Measured: Average of 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2011 (estimated)
- Study startMay 2002
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle Malleolus Fracture BimalleolarStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01441817
- Sponsor's protocol ID
- 224-01077(REK)
- Other IDs
- REK
- Status last verified
- Sep 2011
- First submitted
- 15 Sep 2011
- Last updated
- 28 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non--operative Treatment of the Medial Malleolus in bi- and Trimalleolar Ankle Fractures. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01441817
- Acronym / sponsor ID
- 224-01077(REK)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- May 2002
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 28 Sep 2011 (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.
The purpose of this study was to determine if internal fixation of the medial malleolus is necessary following open reduction and internal fixation of the lateral and, if required, the posterior malleolus treating displaced bi-or trimalleolar ankle fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery | Other | Procedure: Internal fixation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with Orthopaedic Trauma Association (OTA) type 44 fractures (B2-3 and C2-3).
Key exclusion criteria (2 listed)
- Patients with OTA type 43 distal tibia fractures.
- Patients with soft tissue injuries involving the medial malleolus.
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 |
|---|---|---|
| Internal fixationInternal fixation of the medial malleolus following open reduction and internal fixation of the lateral and, if required, posterior malleolus. | Procedure or surgery | Surgery |
Primary outcome
American Orthopaedic Foot and Ankle Society ankle hind foot score (AOFAS)
Time frame: Average of 42 months
The Olerud Molander Ankle score (OMAS)
Time frame: Average of 42 months
2 secondary outcomes
Posttraumatic osteoarthritis (OA) according to the criteria of Magnusson (stage I-IV)
Time frame: Average of 42 months
VAS score
Time frame: Average of 42 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 28 Sep 2011.
Related trials for Ankle Malleolus Fracture Bimalleolar
Recruiting
Correlation Between Intraoperative Tourniquet Use and Limb pH, Functional Measures and Patient-reported Outcomes After Ankle Fracture Surgery
Ankle Fractures, Ankle Fracture - Lateral Malleolus
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internal fixation in people with Ankle Malleolus Fracture Bimalleolar and Fracture of Medial Malleolus, run by Oslo University Hospital at 1 site in Norway.
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 2 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 28 Sep 2011. 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 Norway. 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?
American Orthopaedic Foot and Ankle Society ankle hind foot score (AOFAS) (time frame: Average of 42 months). 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 28 Sep 2011.