Ankle FractureNCT02779244
Early Weight Bearing for Unstable Ankle Fractures Undergoing Operative Stabilization
A study testing Early Weight bearing + Cam Boot and Non-Weight Bearing + Cam Boot in people with Ankle Fracture, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this randomized, controlled trial is to estimate the safety of early weight bearing on post ankle surgery. Patients who are indicated to have surgery for unstable ankle fractures by an attending trauma physician will be consented for participation in the study. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ankle Fracture
- What is being tested?
- Early Weight bearing + Cam Boot and Non-Weight Bearing + Cam Boot
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 1 Jul 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Operative unstable ankle fractures
Who cannot join
- Requirement of syndesmotic fixation
- Pilon fractures
- Open fractures
- Patients with diabetic neuropathy
- BMI>40
- Polytrauma patients
- Patients who are unable to comply with non-weight bearing
- Patients who are unable to follow up
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University Langone Medical Center
New York, New York, 10016
About this study
Official title: Early Weight Bearing for Unstable Ankle Fractures Undergoing Operative Stabilization: Is It Safe and Does It Improve Outcomes?
The purpose of this randomized, controlled trial is to estimate the safety of early weight bearing on post ankle surgery.
Patients who are indicated to have surgery for unstable ankle fractures by an attending trauma physician will be consented for participation in the study. After surgery patients will be randomized to either weight bearing as tolerated at two weeks with a cam boot or non-weight bearing with a cam boot. Randomization will be performed by number allocation with odd numbers in the early weight bearing group and even numbers in the non-weight bearing group. The surgeon will be blinded to this until after the surgery. The patients will all be placed in a short leg cast post operative and made non-weight bearing for 2 weeks until sutures are removed which is current standard treatment. Both groups will be asked to initiate weight bearing at two weeks post operatively by wearing a cam boot that is non weight bearing in a cam boot, the latter being standard treatment.
- Conditions
- Ankle Fracture
- Being tested
- Early Weight bearing + Cam Boot, Non-Weight Bearing + Cam Boot
- Keywords
- Orthopedic, Post-operative, Weight bearing, Range of motion
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Weight bearing + Cam BootProcedure or surgery
Patients will be transitioned to weight bearing as tolerated in a cam boot.
Non-Weight Bearing + Cam BootProcedure or surgery
Subject will be transitioned to non weight bearing cam boot, standard treatment.
| Study group | Role | What they receive |
|---|---|---|
| Early Weight Bearing + Cam boot | Experimental | Not described Receives: Procedure: Early Weight bearing + Cam Boot |
| Standard Treatment Cam boot | Active comparator | Not described Receives: Procedure: Non-Weight Bearing + Cam Boot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Olerud Molander Ankle Score
The Olerud Molander score is scored between 0 - 100 as painless and functionally perfect ankle.
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 posted20 May 2016 (estimated)
- Study start1 Sep 2017
- Primary completion14 Jun 2022
- Study completion1 Jul 2023
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.
- More trials run by NYU Langone HealthThe 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nirmal Tejwan, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02779244
- Sponsor's protocol ID
- 16-00720
- Status last verified
- Nov 2023
- First submitted
- 16 May 2016
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Weight Bearing for Unstable Ankle Fractures Undergoing Operative Stabilization: Is It Safe and Does It Improve Outcomes?
- ClinicalTrials.gov ID
- NCT02779244
- Acronym / sponsor ID
- 16-00720
- Conditions
- Ankle Fracture
- Keywords
- Orthopedic, Post-operative, Weight bearing, Range of motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 14 Jun 2022 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 20 May 2016 (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 randomized, controlled trial is to estimate the safety of early weight bearing on post ankle surgery.
Patients who are indicated to have surgery for unstable ankle fractures by an attending trauma physician will be consented for participation in the study. After surgery patients will be randomized to either weight bearing as tolerated at two weeks with a cam boot or non-weight bearing with a cam boot. Randomization will be performed by number allocation with odd numbers in the early weight bearing group and even numbers in the non-weight bearing group. The surgeon will be blinded to this until after the surgery. The patients will all be placed in a short leg cast post operative and made non-weight bearing for 2 weeks until sutures are removed which is current standard treatment. Both groups will be asked to initiate weight bearing at two weeks post operatively by wearing a cam boot that is non weight bearing in a cam boot, the latter being standard treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Weight Bearing + Cam boot | Experimental | Procedure: Early Weight bearing + Cam Boot |
| Standard Treatment Cam boot | Active comparator | Procedure: Non-Weight Bearing + Cam Boot |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Operative unstable ankle fractures
Key exclusion criteria (8 listed)
- Requirement of syndesmotic fixation
- Pilon fractures
- Open fractures
- Patients with diabetic neuropathy
- BMI>40
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 |
|---|---|---|
| Early Weight bearing + Cam BootPatients will be transitioned to weight bearing as tolerated in a cam boot. | Procedure or surgery | Early Weight Bearing + Cam boot |
| Non-Weight Bearing + Cam BootSubject will be transitioned to non weight bearing cam boot, standard treatment. | Procedure or surgery | Standard Treatment Cam boot |
Primary outcome
Olerud Molander Ankle Score
Time frame: 1 year
The Olerud Molander score is scored between 0 - 100 as painless and functionally perfect ankle.
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 3 Nov 2023.
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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.
Nirmal Tejwan, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Weight bearing + Cam Boot and Non-Weight Bearing + Cam Boot in people with Ankle Fracture, run by NYU Langone Health at 1 site in United States.
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 8 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 3 Nov 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 United States. 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?
Olerud Molander Ankle Score (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 3 Nov 2023.