Ankle FracturesNCT03084263
Arthroscopic Assisted Open Reduction Internal Fixation Versus Open Reduction Internal Fixation in Ankle Fractures
A study testing Arthroscopic Assisted Open Reduction Internal Fixation and Open Reduction Internal Fixation in people with Ankle Fractures, run by Corewell Health West at 1 site in United States.
Trial summary
The objective of this study is to compare the functional outcomes of patients with ankle fractures treated by Arthroscopic assisted Open Reduction Internal Fixation (AORIF) versus Open Reduction Internal Fixation (ORIF). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankle Fractures
- What is being tested?
- Arthroscopic Assisted Open Reduction Internal Fixation and Open Reduction Internal Fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 1 May 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Closed ankle fractures (44A, 44B, 44C)
- Ages of 18-65
- Men or women, including pregnant women
- Willing to consent
Who cannot join
- Open fractures
- Other lower extremity injuries/conditions that affects functional outcomes
- Problems maintaining follow up (homeless, not willing to return for follow up)
- Prisoners
- Unable to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison Study of Arthroscopic Assisted Open Reduction Internal Fixation (AORIF) Versus Open Reduction Internal Fixation (ORIF) in Ankle Fractures: Does AORIF Improve Functional Outcomes?
The objective of this study is to compare the functional outcomes of patients with ankle fractures treated by Arthroscopic assisted Open Reduction Internal Fixation (AORIF) versus Open Reduction Internal Fixation (ORIF).
Read the detailed description
Prospective Randomized Clinical Trial evaluating patients with ankle fractures undergoing AORIF versus ORIF
Participants will be randomized into 2 different surgical groups, one group receiving only ORIF and the other group receiving AORIF.
As standard of care patients will follow up in the office at approximately 3 weeks, 6 weeks and 12 weeks post operatively. Patients will be immobilized in a splint and will be non-weight bearing until their 3 week post-op visit. At the 3 week post-op visit, the patient will be fitted in a boot, be instructed to begin self-directed ROM and to continue non-weight bearing. At the 6 week post-op visit, the patient will begin weight bearing in the boot.
In office study visit will occur at these same times. At each visit weight bearing status, return to sports, pain level, AOFAS and FAAM will be assessed. One additional study visit will be conducted over the phone or by mail at approximately one year post operatively and will consist of the FAAM.
- Conditions
- Ankle Fractures
- Being tested
- Arthroscopic Assisted Open Reduction Internal Fixation, Open Reduction 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.
Arthroscopic Assisted Open Reduction Internal FixationProcedure or surgery
Also called AORIF
Surgical fixation of ankle fractures with use of arthroscopy.
Open Reduction Internal FixationProcedure or surgery
Also called ORIF
Surgical fixation of ankle fractures.
| Study group | Role | What they receive |
|---|---|---|
| AORIF of Ankle Fractures | Experimental | Arthroscopic Assisted Open Reduction Internal Fixation of ankle fracture. Receives: Procedure: Arthroscopic Assisted Open Reduction Internal Fixation |
| ORIF of Ankle Fractures | Active comparator | Open Reduction Internal Fixation of ankle fracture. Receives: Procedure: Open Reduction Internal Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Orthopedic Foot and Ankle Score (AOFAS)
Compare AOFAS scores between AORIF versus ORIF of ankle fractures.
Measured: 6 month
Foot and Ankle Ability Measure (FAAM)
Compare FAAM scores between AORIF versus ORIF of ankle fractures.
Measured: 1 year
Rate of Return to Sports
Compare Return to Sports rates between AORIF versus ORIF of ankle fractures.
Measured: 1 year
Secondary outcomes (2)
Rates of Complications
Compare rates of Complication between AORIF versus ORIF of ankle fractures.
Measured: 1 year
Pain Scores
Compare Pain Scores between AORIF versus ORIF of ankle fractures.
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 Mar 2017
- Study start1 May 2017 (estimated)
- Primary completion1 May 2018 (estimated)
- Study completion1 May 2019 (estimated)
Why it stopped: Withdrawn (No Participants Enrolled)
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.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health West
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Anderson, MD, Principal investigator, Corewell Health West
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03084263
- Sponsor's protocol ID
- 2017-061
- Status last verified
- May 2017
- First submitted
- 14 Mar 2017
- Last updated
- 25 May 2017
- 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 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Study of Arthroscopic Assisted Open Reduction Internal Fixation (AORIF) Versus Open Reduction Internal Fixation (ORIF) in Ankle Fractures: Does AORIF Improve Functional Outcomes?
- ClinicalTrials.gov ID
- NCT03084263
- Acronym / sponsor ID
- 2017-061
- Conditions
- Ankle Fractures
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn (No Participants Enrolled)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Corewell Health WestUniversity, hospital or other
- Study start
- 1 May 2017 (estimated)
- Primary completion
- 1 May 2018 (estimated)
- Study completion
- 1 May 2019 (estimated)
- First posted
- 20 Mar 2017 (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 objective of this study is to compare the functional outcomes of patients with ankle fractures treated by Arthroscopic assisted Open Reduction Internal Fixation (AORIF) versus Open Reduction Internal Fixation (ORIF).
Detailed description
Prospective Randomized Clinical Trial evaluating patients with ankle fractures undergoing AORIF versus ORIF
Participants will be randomized into 2 different surgical groups, one group receiving only ORIF and the other group receiving AORIF.
As standard of care patients will follow up in the office at approximately 3 weeks, 6 weeks and 12 weeks post operatively. Patients will be immobilized in a splint and will be non-weight bearing until their 3 week post-op visit. At the 3 week post-op visit, the patient will be fitted in a boot, be instructed to begin self-directed ROM and to continue non-weight bearing. At the 6 week post-op visit, the patient will begin weight bearing in the boot.
In office study visit will occur at these same times. At each visit weight bearing status, return to sports, pain level, AOFAS and FAAM will be assessed. One additional study visit will be conducted over the phone or by mail at approximately one year post operatively and will consist of the FAAM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AORIF of Ankle Fractures | Experimental | Procedure: Arthroscopic Assisted Open Reduction Internal FixationArthroscopic Assisted Open Reduction Internal Fixation of ankle fracture. |
| ORIF of Ankle Fractures | Active comparator | Procedure: Open Reduction Internal FixationOpen Reduction Internal Fixation of ankle fracture. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Closed ankle fractures (44A, 44B, 44C)
- Ages of 18-65
- Men or women, including pregnant women
- Willing to consent
Key exclusion criteria (5 listed)
- Open fractures
- Other lower extremity injuries/conditions that affects functional outcomes
- Problems maintaining follow up (homeless, not willing to return for follow up)
- Prisoners
- Unable to consent
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 |
|---|---|---|
| Arthroscopic Assisted Open Reduction Internal FixationAlso: AORIFSurgical fixation of ankle fractures with use of arthroscopy. | Procedure or surgery | AORIF of Ankle Fractures |
| Open Reduction Internal FixationAlso: ORIFSurgical fixation of ankle fractures. | Procedure or surgery | ORIF of Ankle Fractures |
Primary outcome
American Orthopedic Foot and Ankle Score (AOFAS)
Time frame: 6 month
Compare AOFAS scores between AORIF versus ORIF of ankle fractures.
Foot and Ankle Ability Measure (FAAM)
Time frame: 1 year
Compare FAAM scores between AORIF versus ORIF of ankle fractures.
Rate of Return to Sports
Time frame: 1 year
Compare Return to Sports rates between AORIF versus ORIF of ankle fractures.
2 secondary outcomes
Rates of Complications
Time frame: 1 year
Pain Scores
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2017.
- 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.
Kevin Anderson, MD principal investigator
Corewell Health West
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic Assisted Open Reduction Internal Fixation and Open Reduction Internal Fixation in people with Ankle Fractures, run by Corewell Health West 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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 25 May 2017. 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 was withdrawn before enrolling participants, so there are no results.
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 Orthopedic Foot and Ankle Score (AOFAS) (time frame: 6 month). The study lists 3 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 25 May 2017.