Ankle FracturesNCT03625154
Operative Versus Non Operative Management Outcomes of Isolated Lateral Malleolar Weber B Ankle Fractures
A study testing ankle open reduction internal fixation and non operative management in people with Ankle Fractures, run by Cedars-Sinai Medical Center.
Trial summary
The primary objective of this study is to determine the failure rate and difference in clinical outcomes between operative and non operative treatment of patients with Weber B lateral malleolus ankle fractures with medial clear space widening on gravity stress views. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankle Fractures
- What is being tested?
- ankle open reduction internal fixation and non operative management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2018to 30 Dec 2020
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-65 years old
- able to provide informed consent
Who cannot join
- pregnancy
- prisoners
- psychiatric conditions that prevent ability to provide informed consent or present barriers to follow up
- insulin dependent diabetics
- patients with prior musculoskeletal issues affecting the same extremity
- Patients cannot simultaneously be enrolled in any other studies.
About this study
The primary objective of this study is to determine the failure rate and difference in clinical outcomes between operative and non operative treatment of patients with Weber B lateral malleolus ankle fractures with medial clear space widening on gravity stress views. All patients presenting will be treated non operatively, and compared to an observational group comprised of patients with Weber B lateral malleolus ankle fractures without medial clear space widening, for which the standard of care is non operative management.
Patients who decline non operative management and elect to undergo operative open reduction internal fixation with plates and screws will comprise an operative observational cohort.
All patients will be followed for a total of 12 months from the time of injury. Clinical outcomes will be based on radiographic monitoring for ankle mortise congruency, as well as standardized SF-36 and AOFAS questionnaire scores.
- Conditions
- Ankle Fractures
- Being tested
- ankle open reduction internal fixation, non operative management
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ankle open reduction internal fixationProcedure or surgery
Open Reduction and Internal Fixation with plates and screws
non operative managementOther
closed reduction and splinting followed by progressive weight bearing
| Study group | Role | What they receive |
|---|---|---|
| non operative control group | Active comparator | Patients with negative gravity stress (non-operative treatment/observational control group) Receives: Other: non operative management |
| non operative experimental group | Active comparator | Patients with positive gravity stress (medial clear space > 4 mm on initial injury pre-reduction x-rays, who undergo a reduction with closing of the medial clear space to <4mm. Plan for nonoperative treatment of all these patients with splint and subsequent walker boot. Receives: Other: non operative management |
| operative observational group | Active comparator | Patients with positive gravity stress (medial clear space > 4 mm) who undergo a reduction with closing of the medial clear space to <4mm who declined non-operative treatment but agree to be observed. These patients will undergo ORIF (Open Reduction and Internal Fixation) with plates and screws and function as a second observation group Receives: Procedure: ankle open reduction internal fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
radiographic outcome of ankle congruency
measurement of medial clear space between medial malleolus and medial talar dome, measurement of tibiofibular overlap 1cm superior to the plafond, and measurement of superior clear space between the tibial plafond and the talar dome
Measured: 1 year
Secondary outcomes (5)
functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) scoring system
total score 0-100, with 100 being the maximum best score. (pain (0-40 points), function (0-50 points) and alignment (0-10 points)
Measured: 1 year
additional functional outcome by Short Form Survey (SF-36) Score scoring system
0 to 100 range, 100 being the best; subscores Physical functioning (0-10), Role limitations due to physical health (0-4), Role limitations due to emotional problems (0-3), Energy/fatigue (0-4)Emotional well-being (0-5), Social functioning (0-2), Pain (0-2), General Health 0-5
Measured: 1 year
functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) - Pain score
none, mild occasional, moderate daily, severe and almost always present
Measured: 1 year
functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) - function - activity limitations, support requirements
no limitations and no support, no limitation of daily activities but limitation of recreational activities, limited daily and recreational activities, or severe limitation of daily and recreational activities
Measured: 1 year
functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) - alignment
good plantigrade, midfoot well aligned; fair plamtigrade, some degree of midfoot malalignment, poor with nonplantigrade foot, severe malalignment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start1 Sep 2018 (estimated)
- Primary completion18 Jul 2019 (estimated)
- Study completion30 Dec 2020 (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.
- More trials run by Cedars-Sinai Medical CenterThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles Moon, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03625154
- Sponsor's protocol ID
- Pro47932
- Status last verified
- Aug 2018
- First submitted
- 28 Jun 2018
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operative Versus Non Operative Management Outcomes of Isolated Lateral Malleolar Weber B Ankle Fractures
- ClinicalTrials.gov ID
- NCT03625154
- Acronym / sponsor ID
- Pro47932
- Conditions
- Ankle Fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 18 Jul 2019 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 10 Aug 2018 (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 primary objective of this study is to determine the failure rate and difference in clinical outcomes between operative and non operative treatment of patients with Weber B lateral malleolus ankle fractures with medial clear space widening on gravity stress views. All patients presenting will be treated non operatively, and compared to an observational group comprised of patients with Weber B lateral malleolus ankle fractures without medial clear space widening, for which the standard of care is non operative management.
Patients who decline non operative management and elect to undergo operative open reduction internal fixation with plates and screws will comprise an operative observational cohort.
All patients will be followed for a total of 12 months from the time of injury. Clinical outcomes will be based on radiographic monitoring for ankle mortise congruency, as well as standardized SF-36 and AOFAS questionnaire scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| non operative control group | Active comparator | Other: non operative managementPatients with negative gravity stress (non-operative treatment/observational control group) |
| non operative experimental group | Active comparator | Other: non operative managementPatients with positive gravity stress (medial clear space > 4 mm on initial injury pre-reduction x-rays, who undergo a reduction with closing of the medial clear space to <4mm. Plan for nonoperative treatment of all these patients with splint and subsequent walker boot. |
| operative observational group | Active comparator | Procedure: ankle open reduction internal fixationPatients with positive gravity stress (medial clear space > 4 mm) who undergo a reduction with closing of the medial clear space to <4mm who declined non-operative treatment but agree to be observed. These patients will undergo ORIF (Open Reduction and Internal Fixation) with plates and screws and function as a second observation group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-65 years old
- able to provide informed consent
Key exclusion criteria (6 listed)
- pregnancy
- prisoners
- psychiatric conditions that prevent ability to provide informed consent or present barriers to follow up
- insulin dependent diabetics
- patients with prior musculoskeletal issues affecting the same extremity
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 |
|---|---|---|
| ankle open reduction internal fixationOpen Reduction and Internal Fixation with plates and screws | Procedure or surgery | operative observational group |
| non operative managementclosed reduction and splinting followed by progressive weight bearing | Other | non operative control group, non operative experimental group |
Primary outcome
radiographic outcome of ankle congruency
Time frame: 1 year
measurement of medial clear space between medial malleolus and medial talar dome, measurement of tibiofibular overlap 1cm superior to the plafond, and measurement of superior clear space between the tibial plafond and the talar dome
5 secondary outcomes
functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) scoring system
Time frame: 1 year
additional functional outcome by Short Form Survey (SF-36) Score scoring system
Time frame: 1 year
functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) - Pain score
Time frame: 1 year
functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) - function - activity limitations, support requirements
Time frame: 1 year
functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) - alignment
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ankle open reduction internal fixation and non operative management in people with Ankle Fractures, run by Cedars-Sinai Medical Center.
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 6 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 10 Aug 2018. 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?
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?
radiographic outcome of ankle congruency (time frame: 1 year). 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 10 Aug 2018.