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A Multicenter Randomized Trial Comparing Antiglide and Lateral Plate Fixation in Ankle Fractures

Ankle Fracture Plating: A Multicenter Randomized Trial Comparing Lateral and Antiglide Plating in Displaced Lateral Malleolus Fractures

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00718302
Enrollment
249
Registered
2008-07-18
Start date
2008-06-30
Completion date
2012-12-31
Last updated
2017-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Injuries

Keywords

Ankle Fractures, Displaced Lateral Malleolus Fractures, Antiglide Plating, Lateral Plating

Brief 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). 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.

Interventions

DEVICEAntiglide Plate

A plate is placed behind the broken ankle and secured with screws

DEVICELateral Plate

A metal plate is placed to the side of the broken ankle and is secured with screws

Sponsors

Boston Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Aged \< 18 or over 85 * Open fracture * Prisoners * Unlikely to followup * Non english speaking * Pre-existing arthrosis of the ankle * Limitation in lower extremity function that would affect outcome scoring * Significant anterior comminution precluding antiglide fixation * Bilateral Fracture

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Nonpalpable Hardware3 months, 6 months, 12 monthsPercentage of Participants with Nonpalpable Hardware

Secondary

MeasureTime frameDescription
Percentage Normal Peroneal Tendons3 months, 6 months, 12 monthsPercentage of Participants with Normal Peroneal Tendons
American Orthopedic Foot and Ankle Society Score (AOFAS) Scores3 months, 6 months, 12 monthsAmerican 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.
The Short Musculoskeletal Functional Assessment (SMFA) Score3 months, 6 months, 9 monthsThe 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.
SMFA - Bother Index3 months, 6 months, 12 monthsThe 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.

Countries

Canada, United States

Participant flow

Pre-assignment details

249 subjects were enrolled, but due to patient withdrawal or incomplete data from sites, only 233 subjects entered the flow.

Participants by arm

ArmCount
Antiglide Plate
A plate is placed behind the broken ankle and secured with screws.
119
Lateral Plate
A metal plate is placed to the side of the broken ankle and is secured with screws
114
Total233

Baseline characteristics

CharacteristicAntiglide PlateLateral PlateTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
12 Participants8 Participants20 Participants
Age, Categorical
Between 18 and 65 years
107 Participants106 Participants213 Participants
Sex: Female, Male
Female
66 Participants64 Participants130 Participants
Sex: Female, Male
Male
53 Participants50 Participants103 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
13 / 1198 / 114
serious
Total, serious adverse events
1 / 1191 / 114

Outcome results

Primary

Percentage of Nonpalpable Hardware

Percentage of Participants with Nonpalpable Hardware

Time frame: 3 months, 6 months, 12 months

Population: Participants analyzed at 3 months - 88 (AP) / 89 (LP) Participants analyzed at 6 months - 68 (AP) / 67 (LP) Participants analyzed at 12 months - 53 (AP) / 51 (LP)

ArmMeasureGroupValue (NUMBER)
Antiglide PlatePercentage of Nonpalpable Hardware3 months71 percentage of participants
Antiglide PlatePercentage of Nonpalpable Hardware6 months64 percentage of participants
Antiglide PlatePercentage of Nonpalpable Hardware12 months51 percentage of participants
Lateral PlatePercentage of Nonpalpable Hardware3 months55 percentage of participants
Lateral PlatePercentage of Nonpalpable Hardware6 months66 percentage of participants
Lateral PlatePercentage of Nonpalpable Hardware12 months44 percentage of participants
Secondary

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.

Time frame: 3 months, 6 months, 12 months

Population: Participants analyzed at 3 months - 88 (AP) / 89 (LP) Participants analyzed at 6 months - 68 (AP) / 67 (LP) Participants analyzed at 12 months - 53 (AP) / 51 (LP) Numbers differ due to incomplete data collection or subjects were lost to follow up.

ArmMeasureGroupValue (MEAN)Dispersion
Antiglide PlateAmerican Orthopedic Foot and Ankle Society Score (AOFAS) Scores3 months81.6 units on a scaleStandard Deviation 12.8
Antiglide PlateAmerican Orthopedic Foot and Ankle Society Score (AOFAS) Scores6 months87.24 units on a scaleStandard Deviation 10.74
Antiglide PlateAmerican Orthopedic Foot and Ankle Society Score (AOFAS) Scores12 months90.11 units on a scaleStandard Deviation 9.52
Lateral PlateAmerican Orthopedic Foot and Ankle Society Score (AOFAS) Scores3 months82.8 units on a scaleStandard Deviation 11.69
Lateral PlateAmerican Orthopedic Foot and Ankle Society Score (AOFAS) Scores6 months87.43 units on a scaleStandard Deviation 12.06
Lateral PlateAmerican Orthopedic Foot and Ankle Society Score (AOFAS) Scores12 months89.44 units on a scaleStandard Deviation 11.08
Secondary

Percentage Normal Peroneal Tendons

Percentage of Participants with Normal Peroneal Tendons

Time frame: 3 months, 6 months, 12 months

Population: Participants analyzed at 3 months - 88 (AP) / 89 (LP) Participants analyzed at 6 months - 68 (AP) / 67 (LP) Participants analyzed at 12 months - 53 (AP) / 51 (LP) Numbers differ due to incomplete data collection or subjects were lost to follow up.

ArmMeasureGroupValue (NUMBER)
Antiglide PlatePercentage Normal Peroneal Tendons12 months88 percentage of participants
Antiglide PlatePercentage Normal Peroneal Tendons3 months88 percentage of participants
Antiglide PlatePercentage Normal Peroneal Tendons6 months91 percentage of participants
Lateral PlatePercentage Normal Peroneal Tendons12 months90 percentage of participants
Lateral PlatePercentage Normal Peroneal Tendons3 months88 percentage of participants
Lateral PlatePercentage Normal Peroneal Tendons6 months92 percentage of participants
Secondary

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.

Time frame: 3 months, 6 months, 12 months

Population: Participants analyzed at 3 months - 88 (AP) / 89 (LP) Participants analyzed at 6 months - 68 (AP) / 67 (LP) Participants analyzed at 12 months - 53 (AP) / 51 (LP) Numbers differ due to incomplete data collection or subjects were lost to follow up.

ArmMeasureGroupValue (MEAN)Dispersion
Antiglide PlateSMFA - Bother Index3 months23.1 units on a scaleStandard Deviation 19.05
Antiglide PlateSMFA - Bother Index6 months14.1 units on a scaleStandard Deviation 17.48
Antiglide PlateSMFA - Bother Index12 months12.8 units on a scaleStandard Deviation 18.09
Lateral PlateSMFA - Bother Index3 months25.9 units on a scaleStandard Deviation 20.07
Lateral PlateSMFA - Bother Index6 months19.1 units on a scaleStandard Deviation 20.09
Lateral PlateSMFA - Bother Index12 months16.6 units on a scaleStandard Deviation 22.04
Secondary

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.

Time frame: 3 months, 6 months, 9 months

Population: Participants analyzed at 3 months - 88 (AP) / 89 (LP) Participants analyzed at 6 months - 68 (AP) / 67 (LP) Participants analyzed at 12 months - 53 (AP) / 51 (LP) Numbers differ due to incomplete data collection or subjects were lost to follow up.

ArmMeasureGroupValue (MEAN)Dispersion
Antiglide PlateThe Short Musculoskeletal Functional Assessment (SMFA) Score3 months25.1 units on a scaleStandard Deviation 16.41
Antiglide PlateThe Short Musculoskeletal Functional Assessment (SMFA) Score6 months15.3 units on a scaleStandard Deviation 13.72
Antiglide PlateThe Short Musculoskeletal Functional Assessment (SMFA) Score12 months11.6 units on a scaleStandard Deviation 14.15
Lateral PlateThe Short Musculoskeletal Functional Assessment (SMFA) Score3 months27.2 units on a scaleStandard Deviation 19.36
Lateral PlateThe Short Musculoskeletal Functional Assessment (SMFA) Score6 months18.6 units on a scaleStandard Deviation 18.75
Lateral PlateThe Short Musculoskeletal Functional Assessment (SMFA) Score12 months15.6 units on a scaleStandard Deviation 17.6

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026