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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00718302
Other study ID # H-27190
Secondary ID
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


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
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