Ankle Fracture, BimalleolarNCT05765929
Use of Weightbearing Radiographs to Determine Treatment of bi- and Trimalleolar Ankle Fractures
A study testing Non-operative treatment in people with Ankle Fracture, Bimalleolar and Ankle Fracture, Trimalleolar, run by Ostfold Hospital Trust at 1 site in Norway.
Trial summary
The aim of this study is to evaluate the outcomes after non-operative treatment of weightbearing stable bi-and trimalleolar ankle fractures. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ankle Fracture, Bimalleolar, Ankle Fracture, Trimalleolar
- What is being tested?
- Non-operative treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteNorway
- Study dates
- 28 Feb 2023to 31 Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -With bi- and trimalleolar ankle fractures with less than 7 mm medial clear space on non-weightbearing radiographs that are deemed stable by weightbearing radiographs.
- With type B medial malleolus fractures between the tip and the plafond and type C medial malleolus fractures at the level of the plafond (Herscovici classification). (6)
- With fractures in the distal 1/3 of fibula (not-Maisonneuve)
- Enabling stability evaluation within 14 days after injury
- 18-75 years of age
- with pre-injury walking ability without aids
Who cannot join
- - With primary unstable ankle fractures, > 7mm medial clear space on primary radiographs
- With fracture reduction prior to initial radiographic evaluation, open fracture, fractures resulting from high-energy trauma or multi trauma and pathological fracture
- With type A medial malleolus avulsion fractures < 5mm (at the tip of the malleolus), that are not suitable for surgical intervention.
- With Herscovici type D fractures, involving Lauge-Hansen SA2 fractures (supracollicular fracture - vertical, oblique or transverse direction of the plafond)
- With displaced posterior malleolus fractures that needs fixation in the judgement of the attending surgeon
- With neuropathies and symptomatic joint diseases such as Rheumatoid Arthritis
Show all 12Show fewer
- That are assumed not compliant (such as drug abuse, cognitive- and/or psychiatric disorders)
- With previous history ipsilateral ankle fracture
- With previous history ipsilateral major ankle-/foot surgery
- Who live outside the hospital catchment areas not available to follow up
- With insufficient Norwegian or English language skills
- Non-compliant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Østfold Hospital Trust
Sarpsborg, Østfold fylke, 1714
Marius Molund, MD, PhD, +4790093988, marius.molund@so-hf.no
Grûn, MD, wolfram.grun@so-hf.no
About this study
The aim of this study is to evaluate the outcomes after non-operative treatment of weightbearing stable bi-and trimalleolar ankle fractures.
- Being tested
- Non-operative treatment
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-operative treatmentOther
Patients will be treated with a walker-orthosis for 6 weeks. Weightbearing as tolerated
| Study group | Role | What they receive |
|---|---|---|
| Non-operative treatment | Experimental | Non-operative treatment based on weightbearing radiographs Receives: Other: Non-operative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Olerud Molander Score (OMAS) to measure a change over time
Condition specific, patient reported measure of ankle-fracture symptoms
Measured: 6 week, 12 weeks, 1year, 2 years
Secondary outcomes (6)
Manchester-Oxford Foot Questionnaire (MOxFQ)
Patients reported outcomes
Measured: 6 week, 12 weeks, 1year, 2 years
Range of Motion measured by a goniometer (ad modum Lindsjo)
dorsiflexion and plantarflexion
Measured: 6 week, 12 weeks, 1year, 2 years
Numeric Rating Scale (NRS)
Ankle pain in rest, at night and in daily activities, a 11-point numeric scale ranging from 0-10
Measured: 6 week, 12 weeks, 1year, 2 years
Euroqol questionnaire (EQ- 5D)
Health related quality of life
Measured: 6 week, 12 weeks, 1year, 2 years
Registrations of complications/adverse events
Registration of loss of congruence, delayed union, non-union, thromboembolic events
Measured: 0-2 years
Posttraumatic osteoarthritis (OA)
CT-scan (Kellgren-Lawrence classification)
Measured: 2 years 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 posted13 Mar 2023
- Study start28 Feb 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle Fracture, BimalleolarStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ostfold Hospital Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765929
- Sponsor's protocol ID
- 47891
- Status last verified
- Nov 2022
- First submitted
- 27 Feb 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Weightbearing Radiographs to Determine Treatment of bi- and Trimalleolar Ankle Fractures
- ClinicalTrials.gov ID
- NCT05765929
- Acronym / sponsor ID
- 47891
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Ostfold Hospital TrustUniversity, hospital or other
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 13 Mar 2023 (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 aim of this study is to evaluate the outcomes after non-operative treatment of weightbearing stable bi-and trimalleolar ankle fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-operative treatment | Experimental | Other: Non-operative treatmentNon-operative treatment based on weightbearing radiographs |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- -With bi- and trimalleolar ankle fractures with less than 7 mm medial clear space on non-weightbearing radiographs that are deemed stable by weightbearing radiographs.
- With type B medial malleolus fractures between the tip and the plafond and type C medial malleolus fractures at the level of the plafond (Herscovici classification). (6)
- With fractures in the distal 1/3 of fibula (not-Maisonneuve)
- Enabling stability evaluation within 14 days after injury
- 18-75 years of age
Key exclusion criteria (12 listed)
- - With primary unstable ankle fractures, > 7mm medial clear space on primary radiographs
- With fracture reduction prior to initial radiographic evaluation, open fracture, fractures resulting from high-energy trauma or multi trauma and pathological fracture
- With type A medial malleolus avulsion fractures < 5mm (at the tip of the malleolus), that are not suitable for surgical intervention.
- With Herscovici type D fractures, involving Lauge-Hansen SA2 fractures (supracollicular fracture - vertical, oblique or transverse direction of the plafond)
- With displaced posterior malleolus fractures that needs fixation in the judgement of the attending surgeon
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 |
|---|---|---|
| Non-operative treatmentPatients will be treated with a walker-orthosis for 6 weeks. Weightbearing as tolerated | Other | Non-operative treatment |
Primary outcome
Olerud Molander Score (OMAS) to measure a change over time
Time frame: 6 week, 12 weeks, 1year, 2 years
Condition specific, patient reported measure of ankle-fracture symptoms
6 secondary outcomes
Manchester-Oxford Foot Questionnaire (MOxFQ)
Time frame: 6 week, 12 weeks, 1year, 2 years
Range of Motion measured by a goniometer (ad modum Lindsjo)
Time frame: 6 week, 12 weeks, 1year, 2 years
Numeric Rating Scale (NRS)
Time frame: 6 week, 12 weeks, 1year, 2 years
Euroqol questionnaire (EQ- 5D)
Time frame: 6 week, 12 weeks, 1year, 2 years
Registrations of complications/adverse events
Time frame: 0-2 years
Posttraumatic osteoarthritis (OA)
Time frame: 2 years and 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Ankle Fracture, Bimalleolar
RecruitingObservational study
Use of Bioresorbable Magnesium Set Screws in Syndesmotic Injuries: a Pilot Study
Syndesmotic Injury, Trimalleolar Fracture
Active, not recruiting
Stability of Distal Tibiofibular Syndesmosis With or Without Fixation of Posterior Fragments in Bimalleolar Fractures
Ankle Fractures, Osteoarthritis, Ankle
Not yet recruitingPhase 1
Enhancing Wound Perfusion in High-Risk Lower Extremity Orthopaedic Surgery: A Study on Nitropaste Using Intraoperative SPY Imaging.
Achilles Tendon Repairs/Reconstructions, Pilon Fracture of Tibia
Recruiting
Fibulink Syndesmosis Repair System With Early Full-Weight Bearing
Ankle Fractures, Bimalleolar Fractures
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-operative treatment in people with Ankle Fracture, Bimalleolar and Ankle Fracture, Trimalleolar, run by Ostfold Hospital Trust 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 6 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 8 Aug 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marius Molund, PhD (0047 90093988, mariusmolund@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Olerud Molander Score (OMAS) to measure a change over time (time frame: 6 week, 12 weeks, 1year, 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 8 Aug 2023.