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

NCT ID: NCT00718302

Last Updated: 2017-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 249 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2012-12-31

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.

Conditions

Ankle Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Randomized treatment; antiglide plate

Randomized treatment; antiglide plate

Group Type: EXPERIMENTAL

Antiglide Plate

Intervention Type: DEVICE

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

Randomized treatment; lateral plate

Randomized treatment; lateral plate

Group Type: EXPERIMENTAL

Lateral Plate

Intervention Type: DEVICE

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

Interventions

Antiglide Plate

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

Intervention Type: DEVICE

Lateral Plate

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Paul Tornetta, III, M.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul Tornetta, MD

Role: PRINCIPAL_INVESTIGATOR

Boston University / Boston Medical Center

Laura Phieffer, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

Indiana University

Indianapolis, Indiana, United States

Boston Medical Center

Boston, Massachusetts, United States

Orthopaedic Associates of Michigan

Grand Rapids, Michigan, United States

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Barnes-Jewish Hospital

St Louis, Missouri, United States

New York Hospital for Joint Diseases

New York, New York, United States

Ohio State University Medical Center

Columbus, Ohio, United States

University of Oklahoma/ Health Science

Oklahoma City, Oklahoma, United States

Orthopaedic Specialty Associates Fort Worth

Fort Worth, Texas, United States

Dalhousie University

Halifax, Nova Scotia, , Canada

Countries

United States; Canada

Other Identifiers

H-27190

Identifier Type: -

Identifier Source: org_study_id