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

Ankle Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00718302
• Other study ID #: H-27190
• Status: Completed
• Phase: N/A
• First received: July 16, 2008
• Last updated: March 5, 2013
• Start date: June 2008
• Est. completion date: December 2012

Study information

• Verified date: March 2013
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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). 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Fractures
• Ankle Injuries

Intervention

Device:
• Antiglide Plate
A plate is placed behind the broken ankle and secured with screws
• Lateral Plate
A metal plate is placed to the side of the broken ankle and is secured with screws

Locations

Country	Name	City	State
Canada	Dalhousie University	Halifax, Nova Scotia
United States	Boston Medical Center	Boston	Massachusetts
United States	Ohio State University Medical Center	Columbus	Ohio
United States	Orthopaedic Specialty Associates Fort Worth	Fort Worth	Texas
United States	Orthopaedic Associates of Michigan	Grand Rapids	Michigan
United States	Indiana University	Indianapolis	Indiana
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	New York Hospital for Joint Diseases	New York	New York
United States	University of Oklahoma/ Health Science	Oklahoma City	Oklahoma
United States	Barnes-Jewish Hospital	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Center

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Scores: SF12v2, SMFA, AOFAS ankle/hindfoot scale		Preoperative (or initial hospitalization), 6, 12, 26, and 52 week standard of care visits	No
Secondary	Comparison of functional scores in a priori subgroup: >60 vs <60 years old.		Discharge 6, 9, and 12 months post-operation	No
Secondary	Comparison in functional scores in a priori subgroup: Good bone quality vs poor bone quality		discharge 6, 9, and 12 months post-operation	No
Secondary	Comparison of functional scores in a priori subgroup: Those with syndesmotic injury versus those without.		discharge 6, 9, and 12 months post-operation	No