Clinical trial NCT00718302: A Multicenter Randomized Trial Comparing Antiglide and Lateral Plate Fixation in Ankle Fractures
Official title: Ankle Fracture Plating: A Multicenter Randomized Trial Comparing Lateral and Antiglide Plating in Displaced Lateral Malleolus Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Injuries
Keywords: Ankle Fractures
Displaced Lateral Malleolus Fractures
Antiglide Plating
Lateral Plating
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2008-07-18
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Nonpalpable Hardware
timeFrame: 3 months, 6 months, 12 months
Secondary outcomes:
measure: Percentage Normal Peroneal Tendons
timeFrame: 3 months, 6 months, 12 months
measure: American Orthopedic Foot and Ankle Society Score (AOFAS) Scores
timeFrame: 3 months, 6 months, 12 months
measure: The Short Musculoskeletal Functional Assessment (SMFA) Score
timeFrame: 3 months, 6 months, 9 months
measure: SMFA - Bother Index
timeFrame: 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Grand Rapids
country: United States
facility: Orthopaedic Associates of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: St. Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
city: New York
country: United States
facility: New York Hospital for Joint Diseases
state: New York
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma/ Health Science
state: Oklahoma
city: Fort Worth
country: United States
facility: Orthopaedic Specialty Associates Fort Worth
state: Texas
city: Halifax, Nova Scotia
country: Canada
facility: Dalhousie University
Study officials:
affiliation: Boston University / Boston Medical Center
name: Paul Tornetta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: Laura Phieffer, MD
role: PRINCIPAL_INVESTIGATOR
References: