Ankle InjuriesNCT00718302
A Multicenter Randomized Trial Comparing Antiglide and Lateral Plate Fixation in Ankle Fractures
A study testing Antiglide Plate and Lateral Plate in people with Ankle Injuries, run by Boston Medical Center at 10 sites in 2 countries.
Trial summary
The role of operative fixation of unstable, displaced lateral malleolus fractures is well-established (Mayer, Mak, and Yablon). However, the optimal type of fixation remains the subject of debate. Lag screw fixation alone is only appropriate for long oblique fractures in younger patients (Tornetta). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ankle Injuries
- What is being tested?
- Antiglide Plate and Lateral Plate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Jun 2008to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 - 85
- Closed Unstable Supination Eversion type Weber B fibula fracture
- Soft tissue amenable to operative treatment
- Opt for surgical treatment of their fracture
- Willing to follow up for 1 year
- Consent to be randomized
Who cannot join
- Aged < 18 or over 85
- Open fracture
- Prisoners
- Unlikely to followup
- Non english speaking
- Pre-existing arthrosis of the ankle
Show all 9Show fewer
- Limitation in lower extremity function that would affect outcome scoring
- Significant anterior comminution precluding antiglide fixation
- Bilateral Fracture
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
Boston Medical Center
Boston, Massachusetts, 02118
Ohio State University Medical Center
Columbus, Ohio, 43210
Orthopaedic Specialty Associates Fort Worth
Fort Worth, Texas, 76104
Orthopaedic Associates of Michigan
Grand Rapids, Michigan, 49503
Indiana University
Indianapolis, Indiana, 46202
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
New York Hospital for Joint Diseases
New York, New York, 10003
University of Oklahoma/ Health Science
Oklahoma City, Oklahoma, 73190
Barnes-Jewish Hospital
St Louis, Missouri, 63110
About this study
Official title: Ankle Fracture Plating: A Multicenter Randomized Trial Comparing Lateral and Antiglide Plating in Displaced Lateral Malleolus Fractures
The role of operative fixation of unstable, displaced lateral malleolus fractures is well-established (Mayer, Mak, and Yablon). However, the optimal type of fixation remains the subject of debate. Lag screw fixation alone is only appropriate for long oblique fractures in younger patients (Tornetta). For all other patients, the choices for fibular stabilization most commonly involve the use of plates and screws which can be placed on either the lateral or posterior side of the bone, with or without lag screws. Lateral plating remains the most popular option, but since the description of posterior plating in 1982 (Brunner), reports in the literature have demonstrated some advantages of posterior over lateral plating (Ostrum, Treadwell, Winkler, and Wissing) . These advantages include less dissection, less palpable hardware, and decreased likelihood of intra-articular screw placement. However, there is only a single retrospective study in the published literature directly comparing these two methods (Lamontagne).
Read the detailed description
Since it was first described in 1982, posterior antiglide plating has been presented as an attractive alternative to lateral plating of distal fibula fractures. Biomechanical studies have shown it to be a stronger construct than lateral plating, and other purported advantages include less dissection, decreased potential for intra-articular screw placement, and less palpable hardware decreasing the need for hardware removal.However, although posterior plating has become an accepted technique for operative management of these injuries, there is little clinical information in the literature regarding this treatment, and only one published retrospective study directly comparing posterior to lateral plating.
In 1996, Ostrum published a prospective study evaluating posterior plating in 32 patients, but only compared his results to a cohort of patients treated with lateral plating that was not part of his actual study group.Patel et al. recently presented a retrospective comparison of both techniques, but their study only included 29 patients in the lateral plating group and 23 in the posterior group.In both these studies, posterior plating was felt to be superior to lateral plating based on both the decrease in complications/re-operations related to symptomatic hardware, and improved function and pain scores.
However, in a much larger study, Lamontagneet al. showed no differences in operative time, complications or hardware removal rates in 193 patients reviewed retrospectively, and concluded that they could not recommend one treatment method over the other. They even elected not to proceed with a planned prospective study based on their results.A recent retrospective analysis of 70 patients showed a 43% incidence of need for hardware removal due to pain, with 30% of these patients having peroneal tendon lesions identified intra-operatively.
- Conditions
- Ankle Injuries
- Being tested
- Antiglide Plate, Lateral Plate
- Keywords
- Ankle Fractures, Displaced Lateral Malleolus Fractures, Antiglide Plating, Lateral Plating
- Medical subject headings
- Ankle Injuries, Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antiglide PlateDevice
A plate is placed behind the broken ankle and secured with screws
Lateral PlateDevice
A metal plate is placed to the side of the broken ankle and is secured with screws
| Study group | Role | What they receive |
|---|---|---|
| Randomized treatment; antiglide plate | Experimental | Randomized treatment; antiglide plate Receives: Device: Antiglide Plate |
| Randomized treatment; lateral plate | Experimental | Randomized treatment; lateral plate Receives: Device: Lateral Plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Nonpalpable Hardware
Percentage of Participants with Nonpalpable Hardware
Measured: 3 months, 6 months, 12 months
Secondary outcomes (4)
Percentage Normal Peroneal Tendons
Percentage of Participants with Normal Peroneal Tendons
Measured: 3 months, 6 months, 12 months
American Orthopedic Foot and Ankle Society Score (AOFAS) Scores
American Orthopedic Foot and Ankle Society Score (AOFAS) score. The questionnaire consists of nine items that are distributed over three categories: Pain (40 points), function (50 points) and alignment (10 points). These are all scored together for a total of 100 points. A subject can score anywhere from 0-100, 100 being best.
Measured: 3 months, 6 months, 12 months
The Short Musculoskeletal Functional Assessment (SMFA) Score
The Short Musculoskeletal Functional Assessment (SMFA) score. The questionnaire consists of four categories: Daily Activities, Emotional Status, Arm and Hand Function, Mobility. All categories are scored together, totaling between 0-100. The lower the score, the better the subjects function.
Measured: 3 months, 6 months, 9 months
SMFA - Bother Index
The Bother Index is part of the SMFA. This section focuses on how much the injury is bothering the subject in terms of daily activities and use of injured area. The index totals are between 0-100. The lower the score, the less bothered the subject is by their injury.
Measured: 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ankle InjuriesStudies 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
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Tornetta, III, M.D., Boston Medical Center
- Investigators
- Paul Tornetta, MD, Principal investigator, Boston University / Boston Medical CenterLaura Phieffer, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00718302
- Sponsor's protocol ID
- H-27190
- Status last verified
- Feb 2017
- First submitted
- 16 Jul 2008
- Last updated
- 29 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ankle Fracture Plating: A Multicenter Randomized Trial Comparing Lateral and Antiglide Plating in Displaced Lateral Malleolus Fractures
- ClinicalTrials.gov ID
- NCT00718302
- Acronym / sponsor ID
- H-27190
- Conditions
- Ankle Injuries
- Keywords
- Ankle Fractures, Displaced Lateral Malleolus Fractures, Antiglide Plating, Lateral Plating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 18 Jul 2008 (estimated)
- Results
- Posted 29 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The role of operative fixation of unstable, displaced lateral malleolus fractures is well-established (Mayer, Mak, and Yablon). However, the optimal type of fixation remains the subject of debate. Lag screw fixation alone is only appropriate for long oblique fractures in younger patients (Tornetta). For all other patients, the choices for fibular stabilization most commonly involve the use of plates and screws which can be placed on either the lateral or posterior side of the bone, with or without lag screws. Lateral plating remains the most popular option, but since the description of posterior plating in 1982 (Brunner), reports in the literature have demonstrated some advantages of posterior over lateral plating (Ostrum, Treadwell, Winkler, and Wissing) . These advantages include less dissection, less palpable hardware, and decreased likelihood of intra-articular screw placement. However, there is only a single retrospective study in the published literature directly comparing these two methods (Lamontagne).
Detailed description
Since it was first described in 1982, posterior antiglide plating has been presented as an attractive alternative to lateral plating of distal fibula fractures. Biomechanical studies have shown it to be a stronger construct than lateral plating, and other purported advantages include less dissection, decreased potential for intra-articular screw placement, and less palpable hardware decreasing the need for hardware removal.However, although posterior plating has become an accepted technique for operative management of these injuries, there is little clinical information in the literature regarding this treatment, and only one published retrospective study directly comparing posterior to lateral plating.
In 1996, Ostrum published a prospective study evaluating posterior plating in 32 patients, but only compared his results to a cohort of patients treated with lateral plating that was not part of his actual study group.Patel et al. recently presented a retrospective comparison of both techniques, but their study only included 29 patients in the lateral plating group and 23 in the posterior group.In both these studies, posterior plating was felt to be superior to lateral plating based on both the decrease in complications/re-operations related to symptomatic hardware, and improved function and pain scores.
However, in a much larger study, Lamontagneet al. showed no differences in operative time, complications or hardware removal rates in 193 patients reviewed retrospectively, and concluded that they could not recommend one treatment method over the other. They even elected not to proceed with a planned prospective study based on their results.A recent retrospective analysis of 70 patients showed a 43% incidence of need for hardware removal due to pain, with 30% of these patients having peroneal tendon lesions identified intra-operatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Randomized treatment; antiglide plate | Experimental | Device: Antiglide PlateRandomized treatment; antiglide plate |
| Randomized treatment; lateral plate | Experimental | Device: Lateral PlateRandomized treatment; lateral plate |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged 18 - 85
- Closed Unstable Supination Eversion type Weber B fibula fracture
- Soft tissue amenable to operative treatment
- Opt for surgical treatment of their fracture
- Willing to follow up for 1 year
Key exclusion criteria (9 listed)
- Aged < 18 or over 85
- Open fracture
- Prisoners
- Unlikely to followup
- Non english speaking
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 |
|---|---|---|
| Antiglide PlateA plate is placed behind the broken ankle and secured with screws | Device | Randomized treatment; antiglide plate |
| Lateral PlateA metal plate is placed to the side of the broken ankle and is secured with screws | Device | Randomized treatment; lateral plate |
Primary outcome
Percentage of Nonpalpable Hardware
Time frame: 3 months, 6 months, 12 months
Percentage of Participants with Nonpalpable Hardware
4 secondary outcomes
Percentage Normal Peroneal Tendons
Time frame: 3 months, 6 months, 12 months
American Orthopedic Foot and Ankle Society Score (AOFAS) Scores
Time frame: 3 months, 6 months, 12 months
The Short Musculoskeletal Functional Assessment (SMFA) Score
Time frame: 3 months, 6 months, 9 months
SMFA - Bother Index
Time frame: 3 months, 6 months, 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Ankle Injuries
Recruiting
Lateral Ankle Treatment
Avulsion Fracture
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
Ankle Sprain, Ankle Sprain Strain
RecruitingObservational study
Use of Bioresorbable Magnesium Set Screws in Syndesmotic Injuries: a Pilot Study
Syndesmotic Injury, Trimalleolar Fracture
Not yet recruiting
Outpatient Floor Pedal Bike Utilization
Femur Fracture, Tibia Fracture
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
Ankle Sprains, Ankle Sprain Strain
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.
Paul Tornetta, MD principal investigator
Boston University / Boston Medical Center
Laura Phieffer, MD principal investigator
Ohio State University
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antiglide Plate and Lateral Plate in people with Ankle Injuries, run by Boston Medical Center at 10 sites in 2 countries.
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 9 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 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada. 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?
Yes. Results are posted in the registry (first posted 29 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Nonpalpable Hardware (time frame: 3 months, 6 months, 12 months). 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 29 Mar 2017.